PROGRESS REPORTS

May 2000

Supported by:

National Institute on Aging

National Institute of Nursing Research

Prepared by:

REACH Coordinating Center

University of Pittsburgh

University Center for Social and Urban Research

121 University Place

Pittsburgh, Pennsylvania 15260

REACH Progress Report - Table of Contents

Title Page Number

Executive Summary…...………….………………………………………………….…….. 3

Listing of Program Administrators and Principal Investigators.……………………………7

University of Alabama ……………………………………………….……………….…… 8

Hebrew Rehabilitation Center for Aged, Research and Training Institute……………..….. 19

The University of Tennessee – Memphis…………………………………………….……. 31

University of Miami…………………………………………………………..……………. 38

VA Palo Alto Health Care System and Stanford University School of Medicine…………. 49

Thomas Jefferson University………………………………………………………………. 63

The University of Pittsburgh – Coordinating Center………………………………………. 73

Conceptual Framework Workgroup Progress Report……………………………………… 81

REACH Timeline of Activities for 9-Month Bridge Period and Proposed

Follow-up Phase…………………………………………………………………………….94

REACH Executive Summary

May 2000

Description of Project

Resources for Enhancing Alzheimer's Caregiver Health (REACH) is a five-year initiative that was established in 1995 by the National Institutes of Health under leadership of the National Institute on Aging. Its primary purpose is to carry out social and behavioral research on interventions designed to enhance family caregiving for Alzheimer's Disease and related disorders. Six research sites and a coordinating center have been funded through cooperative agreements with the National Institute on Aging and the National Institute of Nursing Research. These projects focus on characterizing and testing the most promising home and community based interventions for enhancing family caregiving, particularly with minority families. The interventions include psychoeducational support groups, behavioral skills training programs, family-based systems interventions, environmental modifications, and technological computer-based information and communication services. The coordinating center facilitates cooperation and standardization of the core protocol across all sites, and is responsible for developing and maintaining a common database as well as carrying out all cross-site analyses. A major outcome of this initiative will be the availability of a pooled database that will enable investigators to answer key questions about optimal intervention strategies for maintaining and improving the health and quality of life of caregivers of dementia patients. Psychological distress (e.g., depressive symptomatology) is the primary outcome of interest, but impacts on health status, health practices, and health care utilization will also be assessed.

Project Timeframe and Accomplishments (1995-2000)

Year 01: The first year was spent developing the common core assessment battery, study design, and manual of operations. Multiple measures were pretested prior to their implementation. Training and certification procedures for data collection and interventions were also developed for both core and site specific data and for the interventions implemented at each site.

Year 02: During the second year research staff were trained and certified for data collection; data entry and remote data transfer systems were developed and implemented, and personnel were trained in use of common computer hardware and software at the intervention sites. All sites entered the field and began recruitment and data collection. In addition, all follow-up batteries including those aimed at assessing the effects of bereavement and care recipient institutionalization were developed.

Year 03: Recruitment and all interventions continued in year three. Meeting recruitment goals was a primary focus during the year. Several additional assessment instruments were developed, including a Project Evaluation Form, Intervention Delivery Assessment Form and Interventionist Characteristics Form. Given the large number of requests for the REACH assessment battery, all forms as well as instructions for their use were prepared for dissemination on a CD-ROM, which is now available to investigators at a nominal cost.

One of the important contributions of the REACH investigators is the development of a conceptual framework aimed at characterizing diverse social/behavioral interventions and at facilitating cross-site analysis. At the suggestion of the External Advisory Committee REACH investigators began to explore the use of an innovative analytic approach called optimization analysis to the REACH data. If successful, this methodology will enable us to identify the optimal mix of intervention strategies for achieving maximal positive outcomes. During year three the group developed a broad conceptual framework for the REACH project as a whole and identified common metrics that might be used to characterize the interventions or components of interventions at each site.

Year 04: Recruitment closed this year for five of the six sites (one site joined the study late). Data management and quality control procedures, including annual site visits, were implemented to assure that the data are of the highest quality. Interviewer variability, attrition, randomization, intervention drift, and missing data continued to be monitored. Performance on all of these indicators was outstanding across all sites.

A major activity of the REACH group during year four was the further development of the conceptual framework. The interventions were allocated to the framework using Analytical Hierarchy Process and then validated by a group of internal raters. Preliminary optimization analyses were performed and demonstrated that statistical optimization techniques can be successfully applied to the REACH dataset.

A psychometric analytical approach was also developed during year four and preliminary analyses on the core assessment battery were completed. These analyses were presented to the REACH psychometric consultant, Dr. John Nesselroade, for approval and further suggestions. Plans were made for carrying out baseline and six-month psychometric analyses during year five once the final data set becomes available.

Dissemination activities for the REACH Team included a book to be published by Springer Publishing in 2000 entitled Handbook of Dementia Caregiving Intervention Research, several in press journal publications and chapters, and numerous symposia and other professional presentations. In addition REACH generated dozens of related journal publications. The REACH website (http://www.edc.gsp h.pitt.edu/reach/) continued to be updated and maintained.

Year 05 (Current Year): The fifth year of this five-year cooperative agreement began on September 1, 1999. Below are the ongoing and completed activities for Year 05:

· Recruitment closed at the sixth intervention site.

· Interventions are ongoing at all sites except Boston.

· Data collection is ongoing at all sites.

· Retention efforts have become a primary focus.

· Initial psychometric analyses are ongoing.

· Baseline and six-month outcomes data analyses are ongoing.

· Conceptual Framework activities include selecting optimization techniques that can be applied to the REACH dataset and developing models that specify the relationship between intervention mechanisms and outcomes. Analyses based on the conceptual framework will begin using the six-month dataset.

· The investigators continue to collaborate in the preparation of multi-site manuscripts and presentations as well as prepare and disseminate site-specific research findings resulting from this research program (in year 05 we will be limited to analysis of baseline and six-month data on non-primary outcomes).

The following major baseline papers are underway:

1. Description of AD caregivers - do caregivers differ by ethnicity in caregiving stressors, appraisal, coping responses, social support, formal supports, and mental and physical health?

2. Stress process model - within a stress process model, what factors predict individual differences in caregiver mental and physical health.

3. Psychometric analyses of instruments/scales used in REACH - multiple papers focused on specific measures will examine ethnic and age-related variation in the measurement properties of instruments used in REACH.

4. Resource utilization - examine resource utilization and cost by ethnicity, caregiver relationship, etc.

5. Recruitment and retention - descriptive paper characterizing process and outcomes.

Current Recruitment Status (Study Participant) as of March 31, 2000*

	University of Alabama	Hebrew Rehabilitation Center for Aged	University of Tennessee	University of Miami	VA Palo Alto Health Care System	Thomas Jefferson University (still recruiting)	All sites Combined
Randomized as of 3/31/00	140	100	245	225	257	255	1222
% White, Caucasian	57.14	79.00	58.37	49.78	57.20	48.24	55.97%
% Black, African American	42.86	16.00	39.59	0.00	0.00	47.84	24.14%
% Hispanic (Mexican)	0.00	0.00	0.00	0.00	29.96	0.00	6.30%
% Hispanic (Cuban)	0.00	0.00	0.41	50.22	0.78	0.00	9.49%
% Hispanic (Puerto Rican, Dominican, Other)	0.00	2.00	0.41	0.00	12.06	1.96	3.19%
% Other (Native American, Asian, No Primary)	0.00	3.00	0.82	0.00	0.00	1.96	0.82%
% Refused	0.00	0.00	0.41	0.00	0.00	0.00	0.08%

*Recruitment completed at all six sites as of 3/31/00

PROGRAM ADMINISTRATORS

Marcia Ory, Ph.D., MPH Mary Leveck, Ph.D., R.N.

National Institute on Aging National Institute of Nursing Research

Bethesda, Maryland Bethesda, Maryland Bethesda, Maryland

(301) 402-4156 (301) 594-5963

COORDINATING CENTER

Richard Schulz, Ph.D Joy Herrington, M.Ed.

Principal Investigator Project Coordinator

University of Pittsburgh University of Pittsburgh

Pittsburgh, Pennsylvania Pittsburgh, Pennsylvania

(412) 624-2311 (412) 624-9177

PRINCIPAL INVESTIGATORS INSTITUTE

Louis Burgio, Ph.D. Applied Gerontology Program

University of Alabama

Tuscaloosa, Alabama

(205) 348-7511

Robert Burns, M.D. University of Tennessee

Memphis, Tennessee

(901) 577-7433

Carl Eisdorfer, Ph.D., M.D. Center on Adult Development and Aging

University of Miami

Miami, Florida

(305) 355-9076

Dolores Gallagher-Thompson, Ph.D. Veterans Affairs Palo Alto Health Care System and Stanford University School of Medicine

Menlo Park, California

(415) 493-5000 x 22005

Laura Gitlin, Ph.D. Community and Homecare Research Division

Thomas Jefferson University

Philadelphia, Pennsylvania

(215) 503-2896

Diane Mahoney, Ph.D. Hebrew Rehabilitation Center for Aged,

Research and Training Institute

Boston, Massachusetts

(617) 363-8545

UNIVERSITY OF ALABAMA*

Skill Training for African American and White Caregivers

REACH Progress Report

May 2000

Louis D. Burgio, Ph.D., Principal Investigator

* Formerly located at the University of Alabama at Birmingham (UAB). The project was transferred to the University of Alabama (UA) in September 1998. Clinical and data collection activities continue at UAB at the direction of a subcontract from UA to UAB.

GOALS OF THE STUDY

Numerous studies have shown that caregiving stress places families at increased risk for high levels of burden, and for poorer well being in such areas as psychological, social, and physical health outcomes. Evidence suggests that African American and White caregivers have a number of problems in common, including managing similar care recipient behavior problems and self-care impairments, and similar reductions in social and leisure activities. This project examines the effects of an intervention designed to address the needs of both African American and White dementia caregivers. Our intervention program combines care recipient-focused behavior management skill training and caregiver-focused problem solving skill training. Behavior management skill training focuses on care recipient behavioral excesses and remediable deficits, which are major caregiver stressors. Caregiver problem solving skills target caregiver behaviors of increasing pleasant events and positive health behaviors; however, caregivers are free to target other problem areas. The effects of caregiver Skill Training is compared with a telephone-based Minimal Support Condition, which provides minimal therapist support to the caregiver. Through 10-20 minute phone contacts, caregivers in the Minimal Support Condition (MSC) receive active listening and empathy from research staff. Both groups receive therapeutic contact at the same intervals and receive non-specific written educational material on dementia and problems associated with the disease.

The project has three specific aims. The first aim is to evaluate the effects of a caregiver training and intervention program on a comprehensive set of measures, as compared with a telephone-based MSC. We hypothesize that the more active skill training based intervention will provide the caregiver with superior caregiving strategies, which may improve the caregiver’s physical and emotional well-being. The second aim is to assess the effects of the skill training intervention program on the behaviors of the dementia patients themselves. We are investigating the impact of the skill-training program on behavioral deficits (e.g., impairment in ADL/IADLs), behavioral excesses (e.g., disruptive vocalization), and a new measure of care recipient quality of life (QOL). The skill training intervention provides the caregiver with superior caregiving skills to address these difficult care recipient behaviors as compared to the MSC. The third aim is to investigate possible racial differences in caregiver skill acquisition and performance, differences in treatment effects on caregiver psychosocial and health related outcome measures, and any differences in the dementia patients' responsiveness to the interventions. Although our intervention has been designed to be culturally sensitive to the caregiving needs of both African Americans and Whites, we will explore differential responses to the intervention program.

SAMPLE RECRUITMENT AND RETENTION

Caregiver-care recipient (CG/CR) dyads were recruited from university sources and community based AD organizations. The UAB Alzheimer's Disease Center Memory Disorders Clinic (ADC; Lindy Harrell, MD, Director), geriatric clinics at UAB, and the UAB Alzheimer's Family Program served as university based recruitment sources. We also received referrals from community based agencies, including the Birmingham Area Visiting Nurses Association (VNA; Morris Hyatt, CEO) and Alzheimer’s of Central Alabama (ACA). All recruitment sites received periodic friendly reminders of our need for subjects. Recruitment and advertising efforts in the greater Birmingham area also resulted in a significant number of self-referrals.

University-based Recruitment Sources

UAB ADC Caregiver Recruitment. Dementia caregivers and their care recipients were identified through our Memory Disorders Clinic (Director, Lindy Harrell, M.D.), which is a multi-disciplinary clinic dedicated to diagnosing, treating, and following patients with cognitive decline. Currently, 400 new and 1200 return visits occur yearly, with African Americans representing 20% of this population and AD representing 90% of all diagnoses.

UAB Geriatric Clinic Caregiver Recruitment. We used the UAB Geriatric Primary Care Clinic (GPCC) and the Geriatric Assessment Clinic (GAC) as secondary sources for recruitment. The GPCC sees approximately 1200 patients per year, including 300 who are new to the UAB system. Twenty-four percent are African American. The GAC sees 250 new patients per year. Most of these patients are referred from outside of the UAB system.

UAB Alzheimer's Family Program. The UAB Alzheimer's Family Program also served as a secondary recruitment source. This program provides advice and information to the caregivers of people with Alzheimer's disease through regular meetings and outreach. In 1995, the Alzheimer's Family Program received approximately 2400 calls from care recipients seeking support. It is estimated that 25% were African American.

Community-based Recruitment Sources

Birmingham VNA Caregiver Recruitment. The Visiting Nurses Association (VNA) of Birmingham is a nonprofit community service organization. The VNA receives over 1200 new referrals per year. It is estimated by the VNA staff that at least 50% or 600 of these admissions are elderly individuals suffering from dementia; 85% (500) of these live with a family caregiver within a 50-mile radius of Birmingham. Approximately 60% of these individuals are African American. Our choice to expand recruitment beyond the university setting was based on two factors. First, accessing the VNA population facilitated our recruitment of a larger number of African American caregiver-care recipient dyads. Second, the RFA states explicitly that every effort should be made to recruit dementia patients with mild to moderate cognitive impairment. Although UAB's ADC has a very successful track record of recruiting African American caregivers and care recipients, African American dementia patients seen at our ADC present primarily with moderate to severe dementia. Recruiting through the VNA allows access to more African American care recipients with mild to moderate dementia. In addition, it broadened our pool of potential participants to include families who do not seek specialized dementia evaluations for their relatives.

Alzheimer’s of Central Alabama (ACA). ACA is a community-based, nonprofit organization serving Alzheimer’s patients and their caregivers. ACA provides direct services to AD patients and their caregivers, provides numerous educational opportunities for family and professional caregivers, funds small university-based research projects, and advocates for AD patients and caregivers on the local and state level. Hundreds of REACH brochures were distributed at ACA events and through their direct mailing. The REACH project was featured in all ACA newsletters.

Recruitment and Advertising Leading to Self-Referrals

Health Fairs. In our area, churches and civic organizations commonly host health fairs to inform people in the community of products and services. During such events, REACH was present to disseminate information about the project by talking with people, handing out flyers and brochures, and distributing REACH magnets.

Speeches/Talks in the Community. Churches, support groups, adult day-care centers, civic organizations (i.e., Civitan International), neighborhood associations and community health organizations asked REACH staff to present the project to their respective groups. These talks generally consisted of a brief description of Alzheimer’s Disease, the accompanying behavior problems, and the burden placed upon families and especially on caregivers. With this background, REACH was discussed in more detail and brochures were distributed to the audience.

Newspaper Ads. Advertising for REACH in newspapers was done in three ways. First, PSA’s were used extensively in smaller local papers such as The Community Messenger, Medwise, and The Birmingham Times. Second, articles were written in community newsletters that describe the REACH project and gave the number to call to inquire for more information. Third, we purchased advertising space for a REACH ad in local daily newspapers. These ads yielded a large proportion of participants enrolled in latter cohorts. This method proved to be very effective in reaching people not served by our recruitment sites.

Radio and Television Coverage. The REACH project was featured on numerous radio talk shows and on local and national television news shows. Drs. Burgio, Stevens or Guy all served as “guest” on local radio talk shows providing general information about AD and specific information on the REACH project. Television coverage was similar in format. One story interviewed a REACH subject who expressed her satisfaction with our program. Nationally broadcast news stories featuring the REACH project appeared on CNN and Headline News.

Mail Outs. During National Alzheimer Month (November), we distributed packets of material to 40 area churches. The packet included an introductory letter about Alzheimer’s Disease and how we can help, the national prayer for those suffering due to the disease, and our REACH brochure. REACH materials were sent to all of the adult day cares centers in the area, with an introductory letter describing the project, and REACH brochures to be displayed in the centers. We also mailed REACH materials to selected physicians serving the Birmingham area.

Entry Criteria

The entry criteria for caregivers and care recipients at the UAB site meet those determined by the REACH Sampling and Recruitment Working Group. The UAB site had three additional entry criteria. Care recipients must display clinically significant behavioral disturbances, defined as a caregiver’s report of at least three problem behaviors. A secondary caregiver who has a minimum of two hours of contact weekly with the caregiver must be available. Participants must identify their primary racial group as either Caucasian or African American.

Time line for Entry of Caregiver/Care Recipient Dyads into Conditions

A total of 140 caregiver/caregiver dyads were entered into the study. The dyads were equally divided into the two conditions: Skill Training (n=70), and MSC (n=70). Using our prediction of a 15% drop out rate, 60 subject dyads per group should complete 12 months, and 54 should complete 18 months. Subjects entered the study during months 12-51 of the project, which corresponded to the calendar dates of September 16, 1996 through May 31, 1999.

Thirteen cohorts of participants were formed and entered into the study. New cohorts were created approximately every 12 weeks. A minimum of ten CR/CG dyads composed each cohort. Cohort start dates were adjusted to reduce conflict with religious and national holidays.

Current Subject (Caregiver) Accrual

As of May 1, 2000, 140 caregivers and their care recipients were entered into the study, with enrollment ending in May of 1999.

	Black, not of Hispanic Origin	White, not of Hispanic Origin	Total
Female	50	61	111
Male	10	19	29
Total	60	80	140

Subject Retention

Continued participation is encouraged in two ways. First, caregivers have regularly scheduled contacts with the same interventionist throughout the course of the study, regardless of intervention condition. It is hoped that such rapport building will facilitate the desire to stay in the study. Second, caregivers receive Bereavement, Holiday, and Get Well cards from the REACH team. Special effort is made to consider the religious and cultural backgrounds of participants. For example, we do not send birthday or holiday cards to people who are Jehovah’s Witnesses.

As of May 1, 2000, the status of some participants has changed due to: 1) death of CR ; 2) placement of the CR into a long-term care setting, or 3) inactivation of participant (i.e., death of CG, CG declined further participation, CG unavailable for interview). Change in CG status may result in the use of the Bereavement or Placement follow-up battery or in complete discontinuation from the project. Information on the number of CG/CR dyads receiving either the Bereavement or Placement battery, or discontinuing participation at the six-month assessment point is summarized in the table below.

Bereavement	Placement	Discontinued
12	8	16

DATA COLLECTION

The study start-date was September 16, 1996. A formal pilot of all experiment procedures and assessments was conducted prior to formal data collection.

Core, Semi-Core and Site Specific measures are administered at four time points; Baseline, 6, 12, and 18 months. In addition to core measures collected by all REACH sites, we collect data to address specific components of our Skill Training and MSC conditions. Two measures, the Functional Independence Measure (FIM) and a problem solving self-efficacy measure, are collected in conjunction with other REACH sites that share similar intervention programs. The FIM is completed at the Alabama, Tennessee, and Philadelphia sites. The self-efficacy measure is completed at the Alabama and California sites. The Alabama site-specific measures include: the SDAT-Screener (a diagnostic interview used by a physician to establish a dementia diagnoses), the Desire to Institutionalize Scale, and the Affect Rating Scale (caregiver-care recipient interactions are videotaped for later scoring). At the Alabama site, we also have a secondary caregiver complete the Revised Memory and Problem Behavior Checklist at core data points. Also at each home visit, Behavioral Logs are collected on both caregiver goal behavior and care recipient behavior.

DATA MANAGEMENT AND ANALYSIS

Quality control procedures for both core and non-core data include case and form checks, data verification, type and range checks, reports for missing data and edits, intra-and-inter-form logical consistency checks, data security, and disaster recovery. Double data entry is used for both core and non-core data. Non-core data are entered into SPSS Data Entry II Database.

In general, statistical analyses will involve repeated measures multivariate analysis of variance with between-subjects factors of Group (Treatment/Comparison Group) and Race (White/African American). Preliminary analyses will be conducted to assure that assignment to group has been successful in assuring that subjects in the Skills Training and Minimal Support conditions have balanced pre-treatment characteristics, as should be the case given the minimization technique. Pre-treatment differences by Race will also be explored and considered closely in subsequent interpretation of treatment outcome data.

The success of the intervention will generally be indicated by significant Group x Time interaction effects. Differential effects of intervention by race would be indicated by Group x Race x Time interaction effects.

INTERVENTION PROTOCOL

Two interventions will be compared in this study: Skill Training and telephone-based Minimal Support.

Skill Training Condition

This intervention package combines care recipient-focused behavior management skill training and caregiver-focused problem solving skill training. Behavior management skill training focuses on care recipient behavioral excesses and remediable deficits, which are major caregiver stressors. Caregiver problem solving skills target caregiver behaviors of increasing pleasant events and positive health behaviors; however, caregivers are free to choose other problems. The Skill Training group participates in a 3-hour group workshop. Caregivers are provided with a skill training manual and videotapes, which demonstrate critical skills. Additional educational materials are provided (See MSC description). Fine-tuning of behavior management and self-management skills, and implementation of individualized caregiver and care recipient-focused behavioral programs is accomplished during home visits. Also during the Home visits, Interventionists observe the caregiver and care recipient while interacting in a social activity. This latter intervention component serves two primary functions: 1) it provides an opportunity to further customize skill training, and 2) it provides an opportunity to videotape the caregiver for later coding with the Affect Rating Scale. Caregivers are asked to complete the Behavioral Log on a daily basis throughout the 18-month study period. This task is made simple with use of the Behavioral Log.

Minimal Support Condition

The telephone-based Minimal Support Condition (MSC) provides telephone support on the same schedule as the home visits in the skill training group. Telephone support is supplemented with printed educational materials on AD and related disorders, and caregiving issues. The purpose of the MSC is to provide researcher contact and support to form a face-valid minimal intervention that will discourage differential drop-out between the more active intervention (Skill Training) and this comparison condition. The support provided by the Interviewer is minimal, consisting of active listening and empathic comments when appropriate. In these comments, the Interviewer neither makes recommendations nor provides additional information on dementia.

TRANSITION ACTIVITIES/CONTINUITY OF SERVICE

Due to our intensive recruitment efforts in the greater Birmingham area, the Alabama REACH project established working relationships with AD-related organizations and became a recognizable presence in the general community. To cultivate our community relations, we are planning events to show our appreciation to the community and have implemented policies to foster future recruitment efforts. Our efforts are outlined below.

1. Participant and Recruiting Agency Appreciation banquets. We will host a REACH participant appreciation banquet at the conclusion of data collection (Fall 2000). All REACH participants will be invited to attend and will receive a certificate of appreciation. A reception will be held to thank our recruitment agencies. The reception is intended to show appreciation for the agency’s staff and will be conducted within the agency.

2. Transition of Recruitment Activities. All of our recruitment activities have continued. The UA/UAB research team has three funded ongoing caregiving research studies. Individuals who inquire about the REACH project are told that the recruitment period has ended. They are offered participation in one of the three ongoing projects. The three projects are 1) Two Methods of Family Caregiver Skill Training (Linda Davis, Ph.D., PI; NINR), 2) ACCESS – Alzheimer’s Care, Compassion, Education, and Social Support (Alan Stevens, Ph.D., PI; NIA, and 3) START – Studying Therapeutic Activities and Recreation as Therapy (Alan Stevens, Ph.D., PI; Alzheimer’s Association).

3. Continuation of REACH’s Presence in the Community. We have continued to have a presence in the local caregiving community. REACH staff members continue to contribute articles to local caregiving newsletters, participate in fund raising events for non-profit organizations dedicated to Alzheimer’s disease, speak to neighborhood associations, and participate in community-based health fairs.

4. Dissemination of Findings. When findings become available, we will work with both the UA and UAB media offices to encourage news stories based on findings. In the past, both media offices have arranged newspaper, radio, and local and national television coverage of our project. A synopsis of the main findings will be mailed to REACH participants and to recruitment agencies.

5. Presentation of Findings to Local Caregiving Groups. When findings become available, we will present at local caregiving conferences and groups. Two annual caregiving training conferences are held in our area. One conference, held in Tuscaloosa, is hosted by Dr. Richard Powers and the Dementia Education Training Act (DETA), which is sponsored by the State of Alabama. The UAB Alzheimer’s Disease Research Center sponsors a second conference. The organizers of these conferences have expressed interest in REACH presentations by Drs. Burgio, Stevens, and Guy. In addition, findings will be presented as part of both UA an UAB scientific seminars.

ANCILLARY/PILOT STUDIES

Ancillary Studies

Two ancillary studies are being conducted. As a dissertation project, Tricia Wessel-Blaski is conducting a micro-analysis of CG and CR behaviors displayed during therapeutic interactions with REACH interventionists. Her project is entitled, “Direct Observation of Dementia Caregiving Interactions: Does Skill Training Influence Quality of Life”. Ms. Wessel-Blaski is currently coding the videotaped interactions between CGs and CRs.

The UA REACH project is serving as a valuable learning and research experience for Dr. Linda Davis. Dr. Davis recently received a Mentored Research Scientist Development Award (MRSDA) from the NINR. Dr. Davis is working with the UA REACH team to gain first hand knowledge and experience in the REACH comparison condition, the Minimal Support Condition (MSC). The MSC is a telephone-based intervention similar to that used by Dr. Davis in her project entitled, “Two Methods of Family Caregiver Skill Training”. To date, Dr. Davis has enrolled 64 CG/CR dyads into the research protocol. Her goal is to enroll 78 dyads. Findings from this study should contribute to the knowledge of methods of delivering skill-training interventions to rural family caregivers.

Pilot Study

Seven subjects were entered into our pilot study. Of this number, one subject failed to complete the core baseline battery, and a second subject asked to be excluded after several weeks of calls in the Minimal Support Condition. Both of these Caregivers were female. Of the remaining 5 dyads, 3 were African American and 2 were White.

The pilot project focused on the development and implementation of behavioral programs to address CR problem behaviors identified by the CR. We created behavior programs to address problem behaviors using the following techniques: distraction, orientation picture books of personal photos, a bulletin board for the dyad to use as a memory aid, reminder identification cards made like business cards to carry in the wallet, and detailed communications skills training.

The pilot study also assisted caregivers with the definition of personal goals that were addressed using problem solving techniques. One caregiver laid plans to have others stay with his wife while he was away from home. Another used these skills to complete construction of a room in her home -- a project that had languished for some time. One caregiver began an exercise program, and another researched day care centers in the area for future use. Upon completion of her research, this CG decided to use one of the centers she had found.

The piloting experience was invaluable to our project and staff for many reasons. Conducting the pilot allowed our team to address numerous issues of critical importance to the overall project. First, piloting allowed us to review issues related to subject referral, recruitment and retention. More specifically, telephone screening gave us data on the number of CG referrals who would be eligible for the study, and we experienced two “drop outs”, which allowed us to begin to identify ways to maximize retention. Second, the entire team gained experience in applying the therapeutic techniques with caregivers and care recipients. This experience included the process of identifying care recipient and caregiver goals, developing behavioral programs, tracking caregiver and care recipient progress, and developing and revising our filing system. Third, we fine- tuned the workshop experience, from presentations and videotaping to providing refreshments and determining the length of breaks.

UPDATE ON RELOCATION OF REACH TO UA AND ESTABLISHMENT OF THE REACH UAB SUBCONTRACT

In year four, the REACH project was relocated to the UA Alabama with clinical activities subcontracted to UAB. Alan Stevens, Ph.D., serves as PI of the Birmingham subcontract. Drs. Stevens and Burgio have a 7-year history of close collaboration on REACH and other NIH funded projects. Dr. Burgio has maintained adjunct appointments at UAB and is provided dedicated office space at both the UA and UAB campuses.

In continuation of the REACH operating procedures established in the first four years of the project, the PI, Co-PIs, Co-investigators and research staff have conducted weekly team meetings attended by staff from both UA and UAB sites. Clinical activities have been unchanged in year five. Dr. Burgio continues to chair the weekly clinical meeting in which case files of all REACH participants are reviewed.

The data entry and management core, along with the dedicated REACH computer and printer, are located on the UA campus in Tuscaloosa. All data entry management and analyses are conducted at UA. All hard data is maintained in Tuscaloosa (clinical files remain at UAB until the participant completes the 18-month assessment). Completed data forms are hand-carried from Birmingham to Tuscaloosa on a weekly basis.

Safe and timely delivery of data forms to the UA site is of highest priority. Data transmissions are coordinated and conducted by the UA data entry coordinator, Mr. Jeff Phillips, and UAB project coordinator, David Vance. Dr. Burgio oversees the data transmission process. To facilitate transition of data and data entry, Mr. Phillips spends one morning per week at the UAB site, this meeting coinciding with the weekly REACH team meeting. During Mr. Phillips’ visits to UAB, he 1) delivers data forms, 2) completes data tracking forms, 3) reviews data forms with Mr. Vance, 4) conducts individual meetings with the REACH interviewers regarding data entry questions, 5) enters treatment fidelity information filed at UAB, and 6) reviews other data concerns during REACH team meeting. Following meetings at UAB, Mr. Phillips hand delivers data forms to the data entry office in Tuscaloosa.

It is the PI’s opinion that from both a scientific and a practical prospective, this arrangement results in a seamless transfer of data from Birmingham to Tuscaloosa, and that subject recruitment and clinical activities have not been adversely affected by the transfer of the REACH project to UA and the establishment of the UAB subcontract.

PRESENTATIONS AND PUBLICATIONS

Burgio, L. D., (1996, November). Skill training for African American and White caregivers. Symposium presented at the 49th Annual Scientific Meeting of the Gerontological Society of America, Washington, D.C.

Burgio, L. D., (1997, May). Skill Training for African-American and White caregivers. In Resources for Enhancing Alzheimer’s Caregiver Health (REACH): Innovative Approaches to AD Caregiving Interventions. Presented at the 1997 annual meeting of the American Geriatrics Society and American Federation for Aging Research, Atlanta, GA.

Stevens, A. B. & Burgio, L. D. (1998, August). Geropsychologically Based Training for Caregivers of Patients With Alzheimer’s Disease. In D. S. Glenwick (Chair), Teaching Clinical Geropsychology to Traditional and Nontraditional Populations. Symposium conducted at the annual meeting of the American Psychological Association, San Francisco, CA.

Stevens, A. B. & Burgio, L.D. (2000, March). Skills Training for African American and White Caregivers. In L.N. Gitlin (Chair), Documenting and Implementing Innovative Home-Based Programs for Alzheimer’s Family Caregivers: Lessons from the REACH Study Cooperative. Symposium conducted at the annual meeting of the American Society on Aging, San Diego, CA.

Stevens, A. B. & Burgio, L.D. (2000, March). Skills Training for African American and White Caregivers. In P. Dilworth Anderson (Chair), Intergenerational Resources. Symposium conducted at the 21^st annual meeting of the Southern Gerontological Society, Raleigh, NC.

DATA COLLECTION

Individual study participants were followed at six-month intervals throughout an 18-month data collection period. Project data collection commenced in November of 1996 and ended April 2000. The initial baseline interview was conducted in the home to obtain written informed consent and to permit training on the TLC system to those randomized to the TLC intervention. Thereafter, data collection occurred by telephone interview at 6 months, 12months, and 18 months. Interviewers requested that the participants not mention their group assignment. Data collection measures at T6 did not identify TLC-AD use. At T12 the TLC-AD user satisfaction survey was administered at the end of the telephone interview to minimize interviewer bias. All subjects ended participation after the 18-month telephone interview. The New England Research Institutes (NERI) was responsible for the field work and data collection.

Every subject was asked the core measurement and site specific battery of questions. Boston site-specific non-core measures included:

Role Captivity (Pearlin) Role Overload (Pearlin), Caregiver Competence (Pearlin), Management of Situation (Pearlin), Mastery (Pearlin), Activity, (Pearlin), and items on Caregiver Health Counseling, Occupation and Income, Health Insurance Coverage and CG preference for assistance.

In addition, the following information was collected only during one measurement period. At baseline: Caregiver height, weight, medication usage, and CR medication usage. Post-intervention Satisfaction with information (both groups) and the Users evaluation of the TLC system (intervention group only).

The TLC data system and Octel voice mail system provided utilization data for all computerized aspects of the TLC intervention throughout the entire intervention period.

DATA MANAGEMENT AND ANALYSIS

Data management is under the purview of the New England Research Institutes. The site follows core data management protocols as developed and parallel their use for the site level data. NERI follows their standard procedures, which include: Maintenance of contact records for all participants; Use of a log to ensure that all data items have been completed for each participant; Central data editing and processing; Maintenance of cumulative production statistics and; Use of a back-up database system. Their Database Manager has been trained by the Coordinating Center in the use of the POP system. Double data entry is used for both core and non-core data. Non-core data is managed using Foxpro and converted to SPSS for windows for data analysis.

Overview of Analysis Plan

The primary evaluation will focus on the comparison of the TLC-AD and UC/control groups at the 12 month follow-up, which corresponds to the end of the intervention period. Additional data from the 6-month follow-up will give us information about initial effects of the TLC-AD system, and will allow us to compare utilization of the system from the first 6 months to the second 6 months of intervention. Additional data from the 18-month follow-up, 6 months after the end of the intervention period, will allow us to look for possible carry over effects of the TLC intervention.

The analysis plan for this study will consist of four stages. First, preliminary analyses will look at study enrollment, randomization, and loss to follow-up. Also, the distribution of study variables will be examined to determine the need for data transformation or recoding. The second stage of analysis will compare the TLC and UC groups on the primary study outcomes of stress and the manifestations of stress at the 12-month follow-up. The third stage will examine mediating and process variables to better understand how TLC impacts stress and the manifestations of stress. These analyses will include data from the 6 and 18-month follow-ups. Finally, the fourth stage of analysis will examine the secondary aims of describing the trajectory of CGs’ needs over the study period, and examine factors related to the use and acceptance of TLC-AD.

INTERVENTION PROTOCOL

There were two groups participating in this study, one the intervention group which receives the telephone based REACH for TLC system intervention, and the other a control group which received usual care.

Intervention Group - REACH FOR TLC

CGs randomized to the intervention group received training on how to use their telephone to access the TLC system. The TLC system offered four components that provided options to meet diverse CGs needs over time.

CG monitoring and Counseling Module. Once a week CGs called into Reach for TLC and it queried CGs about problematic behaviors exhibited by their CR. If none were detected, the CG was reminded about the other system options, given a choice to switch to them or end the conversation. If problematic behaviors were detected, the program branched to offer information about strategies to reduce them. If over a two-week period, the CG reported increasing stress and or CR behavioral problems, a computer generated alert was sent to the AD site liaison. If this continued in week 3, the system triage nurse was alerted to follow-up with the site liaison.

CG Voice Mail Bulletin Board. Designed to be an in-home support group,

any CG could anonymously ask all participating TLC CGs a question about caregiving issues or offer advice in response to questions by other CGs. They could also send and receive personal messages to others on the system through their individual mailbox.

Ask-the-Expert Module. CGs could call into the triage nurse’s voice mail and leave a question for her or the experts. The nurse specialist monitored this line and either responded directly or triaged the call to the appropriate expert on our Advisory Board and ensured that the questions were answered in a timely manner.

Activity/Distraction Module. This was an 18-minute conversation designed to engage the person with AD in a simple non-demanding conversation designed to distract the person from disruptive behavior. The conversation was individualized and used the CR’s name and fostered the recollection of favorite memories such as favorite activities, people, flowers, foods, and holidays. The system started when the CG called in and told the CR that the telephone call was for him/her and pressed 1 on the touch-tone telephone keypad. The conversation was designed to proceed even if the CR did not verbalize any responses. For non-verbal users, strategically placed timed pauses allowed the conversation to continue in order to keep their attention. For verbal users, as soon as they responded, the system proceeded to the next conversation point. The system was also able to adapt if a verbal user then changed to a non-verbal one, then the paused timing feature was automatically implemented.

Caregivers could access the REACH for TLC system modules 24 hrs a day.

In addition, CGs continued to receive the usual care and services provided through the AD site that referred them to this project.

Control Group - Usual Care

CGs randomized to the control group were given a resource guide that contained similar information to that available in the REACH for TLC CG’s Monitoring and Counseling Module, only in written format, not via the TLC system. They continued to receive the usual care and services provided through the AD site that referred them to this project. At the completion of their 18 months participation, the control group was offered use of the TLC respite call. Nine subjects requested use of the TLC system and were provided training and given access to the system.

Ongoing Community Dissemination Activities

Fufilled commitment to control group to offer use of intervention after 12-month participation and 9 of the control group respondents participated

· Statewide community and service agency AD training presentations (20 per year).

· Tarlow and Rosenberg attend monthly Multi-Cultural Partnership on Aging meetings.

HRCA/ REACH team conducted 5 workshops at annual educational conference.

Rosenberg is chair of State Alzheimer’s Association Research Committee.

· Mahoney:Faculty for

· Harvard’s Division on Aging Summer Institute on AD training,

· HRCA Annual symposium on AD ( for the public and service providers).

· Channel 5, two part series on aging with Janet Wu, reporter.

· Tarlow provided content for Boston Globe article on AD and Internet use.

· Brandeis University, Heller School symposium on caregiving / disadvantaged.

· ADRC education and training core project. Minority outreach component and ed.

· Consult to MA AD Chapter’s minority outreach workers to design data forms.

· HRCA (annual) / Minority outreach (3 times a year) Newsletters – 6000 on mailing list

· Tarlow provided a piece on AD and Eldercare Web sites, Service offerings.

· Subject requests for continued research participation can be linked to two other computer intervention projects, RECALL and ACISS and medical services can be linked to our memory loss clinic.

ANCILLARY/PILOT STUDIES

REACH Ancillary study

Brooke Harrow, Ph.D., Boston site senior investigator is completing the third year of her NINR funded study: Cost Impacts of Enhancing Alzheimer's Disease Caregiving. Dr. Harrow has collected intervention cost data from the Boston and Miami sites. She has presented her economic analytic plans at both the GSA and APHA. She has also begun analysis of the cost of community care for care recipients and caregiver health service use using core REACH data. She is the lead author/analyst of the resource utilization writing group. She has developed the analytic plan, ascertained 1996 values for cost adjustments and estimates and worked with the Coordinating Center statisticians who will be running the data. She is currently on maternity leave and anticipates that the data will be ready to review upon her return. At that time it is anticipated that a paper on the cost of caregiving will be submitted to a health economics journal.

Administrative supplement

Barbara Tarlow Ph.D., project director examined the cost and outcomes associated with multiple recruitment strategies used to enroll participants at the Boston REACH site. Analysis of the cost data reveals that the cost of recruiting one Alzheimer’s disease caregiver is $101. The total project recruitment costs were $10,127: $7,618 in personnel costs and $2,509 in materials. The higher personnel costs accurately reflect the long and many layered process of identifying appropriate referral sites and gaining their cooperation. Three recruitment methods evolved during the recruitment phase, each method having its own advantages and costs. Clearly the most effective recruitment method was to formally recruit at clinical sites with large pools of potential participants. The results of the cost analysis have been presented at the annual meeting of the Gerontological Society of America in November 1998, Philadelphia, PA. An article reporting these findings received approval from the P and P and was accepted for publication by the Journal of Aging and Health. The manuscript is scheduled for publication in the November 2000 issue. The supplement ended in 1998.

PRESENTATIONS AND PUBLICATIONS

Presentations:

Mahoney, D. Using technology to help Alzheimer’s caregivers. New Jersey Statewide Conference on Alzheimer’s Disease – Expanding Horizons in the community of care. Sponsored by the 3 New Jersey Chapters of the Alzheimer’s Association. Princeton, N.J. April 12, 2000.

Mahoney, D. Using information technology to increase user’s knowledge about Alzheimer’s disease and caregiving issues. Workshop organizer American Society on Aging. March, 2000, San Diego.

Tarlow, B. Reach for TLC (telephone linked care) system for Alzheimer’s family caregivers. American Society on Aging. March, 2000, San Diego.

Mahoney, D. Using a website for qualitative gerontological research: Issues and recommendations. American Medical Informatics Association (AMIA) Nov 9 1999.

Mahoney, D. Issues related to the use of a website for qualitative Research. Gerontological Society of America, (Technology and Aging, Special Interest Group Sponsorship). Nov.21, 1999, San Francisco.

Tarlow, B & Mahoney, D.. Verifying technology training in the Reach for TLC project.: Gerontological Society of America, (Technology and Aging, Special Interest Group Sponsorship). Nov.21, 1999, San Francisco.

Tennstedt, S. and Mahoney, D. Ethnic Differences in Social Support for Alzheimer’s Disease Caregivers. Part of the REACH Symposium, Gerontological Society of America, Nov. 20,1999, San Francisco

Mahoney, D. Heller School , Brandeis University’s Alumni 40^th Anniversary Conference on Social Welfare. The REACH project and caregiving reimbursement issues. Nov 13, 1999.

Tarlow, B. and Mahoney, D. Poster Session: The Cost of Recruiting Alzheimer’s Disease

Caregivers for Research. Symposium on Urban Health Care Policy, Innovative Health Care Policy for the Urban Community: Nursing’s Strategic Role. Sponsored by College of Nursing, University of Massachusetts, Boston, November 13, 1999.

Mahoney, D. Harvard Division on Aging, Japanese Exchange program– Innovative use of technology with Alzheimer’s family caregivers. August 3 1999, Cambridge, MA.

Mahoney, D. The REACH Initiative. Hebrew Rehabilitation Center for Aged. Research in Progress presentation, July 28, 1999.

Mahoney, D. Using technology to help Alzheimer’s caregivers. Alzheimer Association of Eastern Mass. Map Through the Maze, Interdisciplinary Conference for Professionals. May 12, 1999.

Tarlow, B. and Mahoney, D. The high cost of recruitment. Poster session, Alzheimer Association of Eastern Mass. Map through the Maze, Interdisciplinary Conference for Professionals. May 12, 1999.

Tarlow, B. Elder’s use of the WWW. Hebrew Rehabilitation Center for Aged. Research in Progress presentation, April 14, 1999.

Mahoney, D. A content analysis of website discussions by Alzheimer’s family caregivers. American Society on Aging 45^th Annual Meeting, Orlando, March 3-7, 1999.

Mahoney, D. A computer-mediated intervention for Alzheimer’s caregivers. Workshop: Supporting the Efforts of Alzheimer’s Caregivers Through Technology: A Description of Three Technology-based Interventions of the REACH Project. L. Gitlin, S. Czaja & D. Mahoney. American Society on Aging. Conference on June 30, 1998.

Mahoney, D. Using a website for qualitative gerontological research: Issues and recommendations. Gerontological Society of America 51^st Annual Scientific Meeting. Philadelphia, Nov 20-24, 1998.

Harrow, B., Mahoney, D., Czaja, S., & Eisdorfer, C. A plan for cost-effective analysis of interventions designed to enhance family caregiving for Alzheimer’s disease. Gerontological Society of America 51^st Annual Scientific Meeting. Philadelphia, Nov 20-24, 1998.

Mahoney, D. and Tarlow, B. Computer-mediated intervention for Alzheimer’s caregivers, REACH for TLC (Telephone Linked Care). Gerontological Society of America 51^st Annual Scientific Meeting. Philadelphia, Nov 20-24, 1998.

Mahoney, D., Mezey, M. and Zurakowski,T. Nursing special Interest Group Symposium:

In Pursuit of Life, Liberty and Happiness for Older Adults: Challenges and Opportunities for Nursing. Gerontological Society of America. Nov. 21, 1998, Philadelphia, PA.

Tarlow, B. and Mahoney, D. Poster Session: Identifying Cost Effective Recruitment

Strategies for Research Participation by Alzheimer’s Disease Caregivers, Gerontological Society of America. Nov. 21, 1998, Philadelphia, PA.

Mahoney, D. Tailoring technology to Alzheimer’s caregiving. Western Massachusetts Alzheimer’s Association Annual Conference, Nov 4, 1998.

Mahoney, D. Technological tools for Alzheimer’s caregivers. HRCA Alzheimer’s Symposium, October 2, 1998.

Harrow, B., Mahoney, D., Czaja, S., & Eisdorfer, C. Cost-effective approach to cost-effective analysis of interventions designed to enhance family caregiving for Alzheimer’s Disease. Association for Health Services Research, Washington, D.C., June 22, 1998.

Mahoney, D. Reach for TLC (Telephone-Linked Computer). Can technology help Alzheimer’s caregivers manage disruptive behaviors? REACH Symposium -Resources for Enhancing Alzheimer’s Caregiver Health (REACH). R. Burns , L. Burgio and D. Mahoney. American Geriatrics Society Annual Meeting May, 1997.

B. Tarlow, D. Mahoney, & J. Sandaire. Multi-media presentation, REACH for TLC (Telephone Linked Care) 1997. A Map through the Maze. Alzheimer’s Association of Eastern Mass. Interdisciplinary Conference for Professionals. May 12, 1998.

Mahoney, D. Challenges of implementing a telecommunication based intervention: Technical and user issues. Gerontological Society of America 50th Annual Scientific Meeting, November 17th - 21st, 1997, Ohio.

B. Tarlow, D. Mahoney, & J. Sandaire. Multi-media presentation, REACH for TLC (Telephone Linked Care). 1997. Massachusetts Veterans Administration Research Conference - Caring for Patients with Alzheimer’s Disease: Progress Through Knowledge and Caring. April 1997.

Mahoney, D. 1997 Nurse Practitioners Association for Continuing Education (NPACE) - New Models of Geriatric Care –Using technology in AD. (Keynote speaker ) March 15, Boston MA.

Mahoney, D. Reach for TLC (Telephone-Linked Computer). Can technology help Alzheimer’s Caregivers manage Disruptive Behaviors? Gerontological Society of America 49th Annual Scientific Meeting, November 17th - 21st, 1996, in Washington, DC. REACH Symposium -Innovative approaches to AD caregiving interventions, Marcia Ory, Ph.D., organizer.

Mahoney, D. 1996. Responding to Alzheimer’s Disease in Primary Care. Boston Medical Center, Internal Medicine Section Presentation.

Presentations by HRCA Recruitment Manager and Assistant

Rosenberg, R. Caregiving Across Cultures. Alzheimer’s Association of Eastern Mass. Map Through the Maze, Interdisciplinary Conference for Professionals. May 12, 1998.

Rosenberg, R. Issues in Minority Recruitment and Retention. American Society on Aging. Conference, June 30, 1998.

Rosenberg, R. Research Roundtable: An opportunity to bring researchers and African American potential study participants together for discussion about research. Hebrew Rehabilitation Center for Aged. May 7, 1998.

Rosenberg, R. The Aging Brain. Senior Group at People’s Baptist Church, Roxbury, MA March 24, 1998.

Rosenberg, R. Research and Memory. American Association of Retired People, Roxbury, MA Chapter. January 9, 1998.

Freeman, M. Research and Healthy Aging. Weeks House Senior Living, Newton. January 6, 1998.

Freeman, M. Research and Healthy Aging. Casselman House Senior Living, Newton. January 7, 1998.

Freeman, M. Research and Healthy Aging. Smith House Senior Living, Roxbury. January 22, 1998.

Freeman, M. Research and Healthy Aging. Hale House, Boston, MA. April 30, 1998.

Abstracts Under Review:

Gerontological Society of America Nov 2000, Washington DC. REACH symposium entitled: Innovative methodologies from the REACH project: Lessons learned tasks ahead. Boston site participants:

D. Mahoney Symposium organizer

B. Tarlow : Positive Aspects of Aging Caregiving Measure

B. Harrow Measuring the Cost of community based care for Alzheimer’s family caregivers

REACH PUBLICATIONS

Handbook on Dementia Caregiving. R. Shultz, ed. New York: Springer Publications.2000

Tennstedt, S. Chap 1. The extent and impact of family caregiving.

Tarlow, B. Chap 4. The Pragmatics of implementing intervention studies in the community.

Mahoney, D. & Harrow, B. Chapter 8, From intervention studies to public policy: Translating research into practice.

Mahoney, D., Tennstedt, S., Friedman, R. & Heeren, T. (1999) An automated telephone

system for monitoring the functional status of community-residing elders. The Gerontologist. 39(2) 229-234.

Mahoney, D. A content analysis of an Alzheimer family caregivers virtual focus group. (1998). American Journal of Alzheimer’s Disease. 13(6) 309-316.

Mahoney D., Tarlow, B.& Sandaire, J. (1998) A computer-mediated Intervention for Alzheimer’s Caregivers. Computers in Nursing, 16(4), 208-218.

Mahoney, D. (1998) Alzheimer’s Disease technology interventions for caregivers. Brown University, Quality Advisor. 10 (11) 2-3.

Mahoney, D. Nurses can use technology for the underserved. (1997). The American Nurse, 4:5.

Friedman, R. Stollerman, J., Mahoney, D. & Rozenblyum, L. (1997). Virtual Visit: Using Telecommunications Technology to take care of patients. Journal of the American Medical Informatics Association. 4:413-425.

Publication in Process:

Tarlow, B. & Mahoney, D. The cost of recruiting Alzheimer’s disease caregivers for research. Journal of Aging and Health. Scheduled for November 2000.

Publications Under Review:

Mahoney, D.F. Developing Technology Applications for Intervention Research: A Case Study. Computers in Nursing

Related Media/Press Coverage:

Mahoney, D. Consultant and quoted in Alzheimer’s disease: Glimmers of hope – Progress on prevention, early diagnosis, and more effective treatment and coping strategies. Consumer Reports – On Health 12(4),1-5. April 2000.

Mahoney, D. & Tarlow, B. Memory Loss feature – Channel 5, Boston evening news segment, March 31, 2000

Mahoney, D. Coming of Age. Two part TV News series on Channel 5, Boston by reporter Janet Wu. March, 2-3, 1999.

Mahoney, D. Alzheimer’s Disease. On Call Magazine, interview and quotes. Fall, 1999.

Awards:

Mahoney, D. National Library of Medicine, Medical Informatics Fellowship, June 1999.

THE UNVERSITY OF TENNESSEE – MEMPHIS

Providers and Alzheimer's Caregivers Together (PACT)

REACH Progress Report

May 2000

Robert Burns, M.D., Principal Investigator

GOALS OF THE STUDY:

The purpose of the Memphis PACT study is to examine which of three primary care-based interventions, varying in intensity, will be the most effective in relieving caregiver burden for those caring at home for relatives with Alzheimer’s disease and related dementia disorders. Each caregiver-patient pair is randomly assigned to one of three interventions: Information and Referral (Group A), Behavior Care (Group B), and Enhanced Care (Group C). Group A, the least intensive and extensive intervention, simulates usual care of dementia patients in the community with general written information about dementia. In Group B, the caregivers receive education sessions about behavior management of the care recipient, including problems such as ADLs and wandering. In Group C, specific stress/behavior management for the caregiver (including such topics as anger, grief, and guilt) is provided in addition to the general information received by Group A and the care recipient behavior modification taught to participants in Group B.

The primary goal of the study is to reduce caregiver burden and stress. The level of caregiver burden and stress should decrease from condition A to C. Caregivers who participate in intervention Groups B (Behavior Care) and C (Enhanced Care) should experience lower levels of stress, burden and health care utilization (lower use of psychotropic drugs, fewer scheduled/ unscheduled medical visits, lower rates of institutionalization) compared to those caregivers in Group A (Information and Referral).

SAMPLE RECRUITMENT AND RETENTION:

The Memphis PACT group has elected, at the 24-month assessment, to offer all participants the opportunity to extend participation for a third and fourth year. In year three, participants from Group A who elect to extend participation for a third year are individually re-randomized to either Group B or C. In year four, all participants who elect to extend participation for a fourth year are placed in Group C.

Recruitment Source

Our objective is to examine the feasibility of caregiver support within a primary care environment. As a result, recruitment for the study was focused on patients and their caregivers who were enrolled in the primary care practices targeted by this study. We enrolled 245 caregiver/patient dyads, exceeding our anticipated goal of 240. Seventy-eight participants were randomized to Group A, 85 to group B, and 82 to group C. Medical practices (geriatrics, internal medicine, and family practice) were our source for participant recruitment.

Recruitment of study participants was carried out in the medical practices in several ways. These include: referrals by physicians and medical staff in the primary care offices, medical records review by REACH Researchers of patients scheduled for a visit in the coming month, brochures sent to patients who were being followed in the study practices, information cards in the offices for people to fill out if they were interested in the study, and articles in practice/hospital newsletters.

Entry Criteria

The entry criteria for caregivers and care recipients were those developed by the REACH Sampling and Recruitment Workgroup. There were no additional site-specific criteria.

Current Subject Accrual

We screened 434 participants and approximately 22.4% were ineligible. Reasons for ineligibility were spread across the entry criteria. The number of randomized participants as of 1 June 1999 is shown in the Table below. As of the end of May1, 2000, 245 six-month, 237 twelve-month, and 182 eighteen-month follow-up interviews have been completed for participants.

	American Indian, Eskimo, Aleut	Hispanic	Black, Not of Hispanic Origin	White, Not of Hispanic Origin	Other	Total
Female	1	1	85	103	2	192
Male		1	14	38		53
Total	1	2	99	141	2	245

Subject Retention

A number of incentives were offered to caregivers and to practices in exchange for their assistance and time and use of their facilities. Caregiver incentives included a cash gift for each completed data collection visit, paid parking or nominal amount given for cab fare, and birthday and holiday cards for caregivers and care recipients. As of May 1, 2000, 22 participants had discontinued the study, see Table below.

Deaths/Bereavements	Discontinued	Placement
30	22	19

DATA COLLECTION:

Data collection began October 10, 1996. All data are collected at baseline, 6, 12, 18, and 24 months. In addition to core measures collected by all study sites, we are collecting data specific to the PACT study. One measure, the Functional Independence Measure (FIM), is collected in conjunction with some, but not all, study sites (“Semi-Core”). The Memphis site-specific measures (“Non-Core”) include: Cantril Ladders for Global Health Satisfaction, Global Life Satisfaction, Global Social Activity, Global Perception of Burden, Global Depression and Global Anger; Rand General Well-Being Scale, revised; Cognitive Status (Perlin); Mastery (Perlin), Personal Gain (Perlin); Loss of Self (Perlin); Blood Pressure; Caregiver Timed Performance; and Intervention Cost Analysis. Intervention measures include Enactment, Readiness, and Process of Care.

DATA MANAGEMENT AND ANALYSIS:

Data management and quality control procedures for Core data follow protocols developed by the Coordinating Center. Core data are entered and verified in the POP entry system by the Data Manager, who is trained and certified in use of the POP system. The Data Manager enters site specific data into an SPSS for Windows (v.9.0) data file. Site specific data are verified immediately after entry of each case, by visual comparison of the SPSS spreadsheet with the hard data form. Periodic range checks are also performed regularly. These methods have been effective in maintaining an accurate non-core database; errors in non-core data are corrected by the Data Manager, and discussed with interviewers if necessary. The Data Manager also carries out regular backup of non-core data to diskette.

Descriptive analyses of baseline core and non-core data have been initiated for internal use. Statistical analyses will focus mainly on comparison of outcomes between the three treatment groups, across the five data collection time points. These comparisons will be made using repeated measures multivariate analysis of variance, with treatment group (Information/Referral, Behavioral Care, Enhanced Care) as a between-subjects variable. Other between-subject variables will include Race and Sex of participants. A significant Treatment x Time interaction is predicted, which would indicate the success of interventions. In addition, the association between Process of Care variables and treatment effectiveness will be assessed.

INTERVENTION PROTOCOL:

A detailed protocol has been developed for each of the three intervention groups. Complete details of the intervention protocol are presented in the PACT Intervention Manual of Operations. This Manual is available upon request. The interventions are:

Information and Referral (Condition A)

The rationale for the information and referral intervention group is to simulate usual care of Alzheimer’s Disease patient in community based practices (control group). The phone numbers to the local Alzheimer’s Association and other national Alzheimer’s resources and pamphlets containing general information about Alzheimer’s Disease and related memory disorders are given to the caregiver at the conclusion of the first visit. The caregiver is provided a general information brochure regarding Alzheimer’s Disease and related health topics at each session. The 8-10 informational brochures do not address behavioral intervention or stress management.

Behavior Care (Condition B)

In addition to the telephone number and general information provided to the information and referral group (Group A), the caregiver receives interventionist directed educational sessions about behavior management of the care recipient. The rationale for this intervention is that through targeted educational sessions on how to manage the behavior problems of the care recipient, the caregiver will be better able to cope with these stressful situations. The intervention focuses on care recipient behaviors including Activities of Daily Living (ADL) tasks as well as specific behavior problems such as aggressive behavior or wandering. The interventionist meets with the caregiver at scheduled office visits and extends education sessions through phone calls between visits. Supplemental phone calls that include interventions occur every two weeks between the baseline intervention and the three-month intervention. After three months, caregivers are called once a month in the months that they are not seen in the primary care physician’s office until their 24-month visit. The caregiver also receives behavior specific handouts to reinforce the specific in-person and phone sessions.

Enhanced Care (Condition C)

The Enhanced Care intervention provides specific stress/behavior management for the caregiver in addition to the general information in Group A and the care recipient behavior modification of Group B. The caregiver meets with the interventionist at scheduled primary care office visits. The rationale for this intervention is that targeted educational sessions, which expand beyond behavior management to include instruction/education in intrapersonal efforts to change how the caregiver thinks or feels may reduce the emotional distress in the situation where the course of events cannot be changed. The specific nature of the cognitive - behavioral skills training includes such topics or concepts as relaxation training and steps to utilize to help cope with negative thoughts and feelings. Supplemental phone calls that include interventions occur every two weeks between the baseline intervention and the three month intervention. After three months, caregivers are called once a month in the months that they are not seen in the primary care physician’s office until their 24-month visit. The caregiver also receives behavior specific and stress management handouts to reinforce the specific in-person and phone sessions.

TRANSITION ACTIVITIES/CONTINUITY OF SERVICE

Listed below are the activities/strategies we plan to utilize in maintaining a presence in the community.

· At 24 months, caregivers in the control group are given the opportunity to extend participation to 36 months and, if they elect to do so, are then re-randomized to a treatment group.

· At 36 months, all caregivers that agree to extend participation to 48 months receive the enhanced care (behavior skills and stress reduction) intervention.

· At 24 months, caregivers are provided with a personalized, engraved medical alert/identification bracelet for the care recipient, or if they prefer, for themselves.

· Interventionists are compiling a list of caregivers who have indicated they would like copies of published REACH data when it becomes available.

· Site personnel will disseminate findings from REACH to the public, including multi-site, as well as site-specific, data.

· We will continue to participate in, and present results to, the local Alzheimer's Network, which is composed of members from the Alzheimer’s Association, other local Alzheimer’s organizations, hospital social workers, local universities/colleges, private and non-profit care managers, and other health and social service agencies serving Alzheimer’s patients and their CGs.

· We will continue to maintain a list of caregivers interested in future research participation.

· We will actively maintain ties with Senior Leaders, Inc., a non-profit senior leadership and empowerment group that has an active 650-person alumni association from its leadership classes and a bi-monthly newsletter that reaches 3600 older persons in the metropolitan area. Senior Leaders also operates the information and assistance Senior Link Hotline telephone service, which provides Alzheimer’s support group information to about 35 - 40 persons per month. We have provided REACH caregivers with the Senior Link Hotline telephone number and have distributed refrigerator magnets with that number throughout the community. We will continue to encourage caregivers to freely use this beneficial resource after the study concludes.

· We will continue to actively work with the local Alzheimer's Association and encourage caregivers to use this resource, including their hotline, library, and referral service.

· At the study's conclusion, we will provide caregivers with a current list of AD-related Web sites.

ANCILLARY/PILOT STUDIES:

Schaefer, A. The Correlation of the Cantril Self-Anchoring Scale and the Screen for Caregiver Burden in Measuring Burden in Caregivers of AD Patients. (10-10-96-05/21/97).

Investigator: Counseling Psychology Doctoral Student, University of Memphis.

Purpose: Determine the utility of Cantril self-anchoring scales in measuring the experience of burden and related constructs in caregivers of Alzheimer's disease patients. Methods: Study of 50 Caregivers of individuals with AD exploring the relationship between a Cantril self-anchoring scale of burden and the Screen for Caregiver Burden and Cantril scales and multiple-item scales of components of burden (including social activity, social support, life satisfaction, anger and depression).

Results: No significant relationship between the Cantril burden scale and the Screen for Caregiver Burden. Significant relationships between Cantril scales and multiple item measures of social activity, social support, and depression

Conclusion: For these three measures, a Cantril ladder, a one question visual scale can be used in place of multiple item scales.

Fichtel, J. The Relationship between Caregiver Stress and Blood Pressure. (06/01/98 – 08/17/98).

Investigator: NIH Summer Medical Student Researcher Award.

Purpose: Examine the relationship between perceived stress (as measured by depression and anxiety) associated with the caregiving role and one physiologic measure of health status (blood pressure).

Methods: Eight REACH Caregivers and eight Non-Caregivers over the age of 50, female, not on blood pressure medication, were administered a standardized questionnaire of stress/burden including depression, anxiety, perceived health, life satisfaction, anger, social activities and well being and wore a 24-hour ambulatory blood pressure monitor. REACH caregivers were administered the questionnaire by trained REACH interviewers and the non caregivers by the student investigator.

Results: All differences (except anger) between caregivers and non caregivers were in the expected direction; with caregivers reporting more stress and showing higher average blood pressure readings than non caregivers. However, none of the differences were statistically significant. Three measures (average overall systolic bp, average systolic bp from 1PM to 10PM, and satisfaction with social activities) approached statistical significance. Caregivers had higher average overall systolic blood pressure and average systolic blood pressure from 1PM to 10PM compared to non caregivers. Caregivers also had lower scores on satisfaction with social activities compared to non caregivers.

PRESENTATIONS AND PUBLICATIONS:

Presentations:

Nichols, L. & Martindale-Adams, J. Primary Care and Alzheimer's Disease: The Resources for Enhancing Alzheimer's Caregivers Health Project. Presented at the Alzheimer's Seminar Series, The Dementia Center and Department of Geriatrics, Little Rock, AR., April, 2000.

Nichols, L. Resources for Enhancing Alzheimer's Caregivers Health (REACH). Health Services Research and Policy Conference, Department of Preventive Medicine, University of Tennessee, Memphis, TN, June, 1998.

Burns, R. Dementia, Caregivers and REACH. University of Tennessee Continuing Education’s 31^st Annual Review Course for Family Practice, University of Tennessee, Memphis, TN, March, 1998.

Nichols, L. Dementia, Caregivers and REACH. Mid-South Hypertension Coalition Meeting, University of Tennessee, Memphis, TN, March, 1998.

Burns, R. Dementia, Caregivers and REACH. Presented at the Neurology Grand Rounds, University of Tennessee, Memphis, TN, November, 1997.

Nichols, L, Gitlin, L, & Burns, R. Interdisciplinary Approaches to Alzheimer’s Disease: Collaboration with Caregivers and Patients. Presented at the All Together Better Health: Improving Collaboration in Education and Practice (also The 19th Interdisciplinary Health Care Team Conference for the United States), London, UK, July, 1997.

Burns, R. Interventions in Primary Care, symposium presentation, "Resources for Enhancing Alzheimer’s Caregiving (REACH): Innovative approaches to AD caregiving interventions," American Geriatrics Society Annual Meeting, Atlanta, GA, May, 1997.

Burns, R. Providers and Alzheimer's Caregivers Together (PACT), symposium presentation, "Resources for Enhancing Alzheimer’s Caregiving (REACH): Innovative approaches to AD caregiving interventions, " 49^th Annual Scientific Meeting of The Gerontological Society, the Sheraton Washington Hotel, Washington, DC, November, 1996.

Publications:

Nichols LO, Malone C, Tarlow B, Loewenstein D. (2000). The pragmatics of implementing intervention studies in the community. In: Schulz R. (Ed), Handbook on dementia caregiving: Evidence-based interventions for family caregivers (pp. 127 -150). NY: Springer.

Mahoney D, Burns R, & Harrow B. (2000). From intervention studies to public policy: translating research into practice. In: Schulz R. (Ed.), Handbook on dementia caregiving: Evidence-based interventions for family caregivers (pp. 249-282). NY: Springer.

Switzer GE, Wisniewski SR, Belle SH, Burns R, Winter L, Thompson L, & Schulz R. (2000). Measurement issues in intervention research. In: Schulz R. (Ed.), Handbook on dementia caregiving: Evidence-based interventions for family caregivers (pp. 187-224). NY: Springer.

Gitlin, L., Corcoran, M., Martindale-Adams, J.L., Malone, C., Stevens, A., & Winter, L. (2000). Identifying mechanisms of action: Why and how does intervention work? In: Schulz R., Handbook on dementia caregiving: Evidence-based intervention for family caregivers (pp. 225-248). NY: Springer.

UNIVERSITY OF MIAMI

Family-Based Intervention for Caregivers

REACH Progress Report

May 2000

Carl Eisdorfer, Ph.D., M. D.,Principal Investigator

GOALS OF THE STUDY

The project employs a Family-Based Structural Multisystems In-Home Intervention (FSMII) to enhance family support for Caregivers of patients with dementia, and is investigating the efficacy of a Computer Telephone Integration System (CTIS) to further enhance the effects of the family intervention. The underlying assumption of this approach is that with rare exceptions, primary caregivers have resources within themselves as well as their families and communities that can be harnessed to reduce or solve problems associated with caregiving.

A particular focus of this study is to develop knowledge that is culturally specific. Specifically the study is examining the efficacy of FSMII and FSMII + CTIS on family functioning, caregiver burden, distress and well being in two groups with different cultural backgrounds (Cuban and White American). The efficacy of the interventions is being assessed relative to a telephone -administered minimal support condition (MSC). A further contribution of this research is the evaluation of using a multidisciplinary intervention that combines psychosocial and engineering solutions in enhancing the support systems of caregivers and alleviating the burden among family caregivers of persons with dementia.

SAMPLE RECRUITMENT AND RETENTION

A total of 224 families are enrolled in the study. The initial recruitment goal was only 216 families. There are at least 36 subjects per cell with a total of at least 72 per intervention collapsing across ethnic groups. The two primary clinical recruitment sites for the subjects were the Wien Center for Alzheimer's Disease and Memory Disorders located at Mount Sinai Medical Center and the University of Miami Memory Disorders Center. Both centers are directed by the project's Principal Investigator, Dr. Carl Eisdorfer. Subjects were also recruited from the community through advertisement (e.g. radio, newspaper, television). Within each family three kinds of subjects are defined for purposes of assessment: the Alzheimer’s Disease patient, the primary caregiver, and another family member. The clinical record of the Memory Disorder Clinics is used to identify the primary caregiver who is defined as the individual providing the most emotional and instrumental support to the AD patient. The family members are defined to include all individuals living in the household on a permanent basis, other immediate family members (sons, daughters, their spouses), or individuals considered to be part of their extended family who provide emotional and/or instrumental support to the AD patient or caregiver on at least a bi-weekly basis.

Entry Criteria

Potential participants were screened using the screening protocol developed by REACH to ensure that they meet the inclusion/exclusion criteria established for the study.

Additional site specific inclusion/exclusion criteria included:

1. The patient has a DSM-IV diagnosis of dementia.

2. To be included in the Cuban-American group, the primary caregiver must self-identify both him or herself and the care recipient as Cuban or Cuban-American. To be included in the White American group, the primary caregiver must self-identify both him or herself and the care recipient as White American.

3. There is at least one family member identified by the primary caregiver as potentially available for providing emotional or instrumental support to the primary caregiver or the patient who is willing to participate in the study

4. The patient must not be functionally blind or deaf.

Current Subject Accrual

The Miami site entered the field in April, 1997. As of March 31^st, 1999, when the recruitment phase of the study ended, 233 participants were enrolled in the study. Two hundred and twenty four of these subjects were randomized, and nine had participated in the project as pilot families. In terms of the follow up assessments we have experienced very few problems primarily related to illness, placement, death, and relocation. When the latter was the case, most subjects still agreed to answer a brief discontinuation battery that is administered over the telephone.

DEMOGRAPHICS

INTERVENTION ASSIGNMENT

ETHNICITY

MSC

FSMII

CTIS

Male

Female

Male

Female

Male

Female

White American

Cuban American

Total

Grand Total

224

Subject Retention

To maintain participation in the study, we try to develop a sense of commitment to the research among the participants by maintaining contact between scheduled assessments. For example, we send thank-you letters, holiday and birthday greetings, etc. We carefully track reasons for discontinuation in the study.

Death

Discontinued

Placement

As shown in the table above, there are 54 caregivers who have discontinued from the study. Many of the early discontinuations were directly related to subjects’ dissatisfaction with randomization on the MSC condition. These caregivers reported that “this condition was not the condition for them”. For example, one person even dropped right after initial assessment and randomization. Another common reason given by the caregiver was that “the presence of others in the home made my (CR) uncomfortable”. The observed increment in the number of caregivers who decided to discontinue from the project is apparent as the number of caregivers who reached the 18^th month mark has increased. Two major reasons have been identified as responsible for this increment: 1) As the number of care-recipients who died increased, caregivers lost interest in the project, and 2) Many caregivers themselves became ill with conditions such as cancer, which prevented them to have time and energy to complete the assessment. Finally, some of the discontinuation batteries could be recovered in the 18^th assessment. Some caregivers chose to temporarily discontinue their participation due to miscellaneous immediate reasons such as a house that burned down, or an emergency long trip to another state.

DATA COLLECTION

The Core battery and site specific measures are collected at baseline (T1), six months after baseline (T2), 12 months after baseline (T3), and 18 months after baseline (T4). The site specific measures include:

Acculturation/Biculturalism Scale (Szapocznik, Scopetta, Kurtines & Aranalde, 1978; Szapocznik Kurtines & Femández, 1980) is made up of a 24-item Behavioral Acculturation Scale and a 24-item Biculturalism Scale. This measure is essential when assessing an immigrant sample of Caregivers such as in the present study. It is also essential in looking at potential breakdowns in family communication due to varying levels of acculturation between parents and children.

The Structural Family Systems Ratings (SFSR; Szapocznik, Rio, Hervis, Mitrani, Kurtines & Faraci, 1991; Szapocznik & Kurtines, 1989; Szapocznik, Kurtines, Santisteban & Rio, 1990) is a family assessment procedure designed for use in evaluating family functioning on the basis of interactional patterns.

F-COPES (Olson & McCubbin, 1982) is a 30 item measure used to measure family coping.

CTIS Assessment Questionnaire Caregivers will be asked to evaluate, via questionnaire, ease of system use, likes and dislikes, usefulness of the system, and perceived benefits.

CTIS Therapist Questionnaire Therapists will be asked to evaluate, via questionnaire, ease of system use, likes and dislikes, usefulness of the system, and perceived benefits.

CTIS Usage Variables include frequency of system use and system features used call duration, date of call, time of call, and communication patterns.

Screen for Caregiver Burden (Vitaliano et al., 1991) is a 25 item scale used to assess subjective burden.

Direct Functional Assessment Scale (DAFS: Loewenstein et al., 1989) is a behaviorally based rating scale which involves the directly observed assessment of a broad range of functional capacities which are often compromised in Alzheimer’s Disease and related disorders

disorders. The DAFS is administered to the patient and will only need to be done at

follow-up assessments. It represents no additional time on the part of the caregiver.

Judgment of Patient Functional Capacity This instrument developed by Loewenstein and Argüelles (1994) is a questionnaire administered to the caregiver regarding functional capacity of the care recipient on tasks evaluated on the DAFS functional scale.

DATA MANAGEMENT AND ANALYSIS

Procedures have been developed for management of the Core and site-specific assessment measures. To ensure quality control of the data, a manual of operations documents the procedures for data collection and management for the Core and site measures. Separate databases have been developed for both the Core and site-specific measures. All data is double-entered by trained and certified data entry personnel. Both simple data range checking and customized data checks are performed on a regular basis to ensure accuracy of data entry. Data entry errors that are identified are reviewed and corrected by the Data Entry Manager.

Software continues to be developed for the CTIS system to refine the collection of continuous, real time system usage data.

INTERVENTION PROTOCOLS

This study employs a Family-Based Structural Multisystems In-Home Intervention (FSMII) and a Computer Telephone Integration System (FSMII + CTIS). Carefully trained and closely supervised family therapists provide treatment in both the FSMII and the FSMII+CTIS conditions. Treatment involves weekly in-home family therapy sessions for the first 4 months of the intervention period, bi-weekly sessions for months 5 and 6 and monthly booster sessions for months 7-12. The duration of each session is approximately 90 minutes.

Family-Based Structural Multisystems In-Home Intervention (FSMII)

The family-based therapeutic intervention is based on a systems approach pioneered by Szapocznik and colleagues for work with depressed elderly Cuban born individuals. Since this early work the intervention has been expanded to a more contextual and multisystemic approach where the individual is viewed as embedded in nested social and cultural systems.

With respect to caregivers, the goal of the intervention is to reduce the distress of managing and living with a person with a dementing illness and enhancing the functioning of the family. The challenge for the family-based intervention research is to identify specific problems caregivers are experiencing, the efficacy of family problem-solving styles and solutions, the range of useable family resources available and accessible to the family, and the capacity of caregivers and their families to collaborate in the caregiving effort. There are three types of therapeutic activities which take place in FSMII: 1) joining, the process of establishing a therapeutic relationship; 2) diagnosis, the identification of maladaptive interactional patterns; and 3) restructuring, defining the nature of the therapeutic interventions that the therapists uses to change the maladaptive patterns.

Computer Telephone Integration System (FSMII + CTIS)

The CTIS system serves to augment the therapeutic intervention. The technological component is comprised of a telephone-like device that is user friendly, and is intended to facilitate interactions between the caregiver, family members, therapist, and other support systems. The system involves the use of screen phones which marry basic telephones with computer inputs and outputs. Screen phones allow text and voice to be sent and received during an interaction session. The system is menu driven and the user is guided through the system by verbal prompts. A number of features are available on the system including: place a call; messaging (both individual and group); conferencing (up to 6 people simultaneously); access to pre-stored information; and other caregiver respite functions.

The system is bi-lingual; all text and voice messages are presented in English and Spanish, depending on the language of the participant.

Minimal Support Condition (MSC)

The control condition is a minimal support control. It consists of the treatment procedure currently used in the Memory Disorders Clinic, and constitutes the baseline that subjects in all conditions receive. In addition, in order to form a face valid minimal intervention subjects in this condition are contacted by a research assistant using the REACH MSC Protocol at approximately the same frequency as in the other two conditions. They will receive biweekly calls for the first six months, and monthly calls thereafter. Educational materials in English or Spanish will be sent to the participants using the protocol developed by REACH.

TRANSITION ACTIVITIES/CONTINUITY OF SERVICES

Below is a list of the activities that the Miami REACH site is proposing in order to maintain a presence in the community as the project is coming to an end:

1. Continue active involvement in efforts to disseminate information regarding the REACH program to the community. These efforts are being directed towards community organizations, health care providers, and families of persons with dementia and include:

2. Regular interaction with the local chapter of the Alzheimer’s Association and the North Miami Senior Foundation.

3. Active involvement in community support groups.

4. On-going contact with the local media via radio and television.

5. Presentation of the REACH program at the conference for health care professionals sponsored by the Miami Area Geriatric Education Center.

6. Presentation of a program on caregiving and the REACH program to the Geriatric Psychiatry Fellow and community Psychologists.

7. Thank you phone calls to REACH participants at the end of the 18 month-protocol.

8. Provision of continued assistance to REACH participants at the end of the 18-month protocol with issues such as placement, medical referrals, and bereavement.

Ancillary / Pilot Studies

The Miami Site has been awarded three minority supplements. All of them are progressing on scheduled as defined by their proposals.

Minority Supplement 1. Awarded to Soledad Argüelles, Ph.D. (11-06-96 to 08-31-98). The primary focus of the study is on the standardization of the caregiver Report of Functional Capacity Questionnaire (CRFP-R, Loewenstein & Argüelles, 1997) with a culturally diverse population. The outcomes of this study will provide valuable information regarding sources of stress for caregivers. Also, since little is known about the relationship between the caregiver’s perceptions of functional capacity and actual functional capacity of the care recipient (CR), it will impact the development of effective interventions for caregivers, which is also the goal of the parent study, by focusing on the mismatch between caregivers expectations and CR’s performance, and do it in light of a culturally diverse population. Furthermore, this information will be extremely valuable in the diagnostic process and will consequently have an impact in the treatment and management of both patients and caregivers. Through her study, Dr. Argüelles will assist us in: 1) determining the extent of the CR and caregiver biases on specific tests of functional capacity in different ethnic groups; and 2) assessing how a caregiver’s perception of functional capacity relative to a person’s actual performance can be influenced by culture and other factors, such as depression, etc. Dr. Argüelles has already completed her data collected and is currently in the manuscript preparation stages.

Minority Supplement 2. Awarded to Martha Corvea, Ph.D. (10-01-97 to 08-31-00)

This study will focus on the observation of recruiters and their clinical notes (10% of the cases) and Structured Interviews with them on randomly selected 50% of the cases for the Miami Site. Dr. Corvea will be responsible for the treatment fidelity aspects of the study, which requires her to be closely involved in all clinical research monitoring activities. She will be responsible to keep the investigators appraised of empirical findings that have implications for intervention implementation in addition to her ratings of treatment efficacy and engagement. Most of the data are rated and entered. Initial analyses have been completed. Further analyses are planned.

Minority Supplement 3. Awarded to Dolores Perdomo, LCSW. (10-01-98 to 08-31-00). Ms. Perdomo will explore the use of the CTIS intervention and the Palo Alto Psycho-educational class intervention on single caregivers. She has recruited 22 subjects; 18 of which are already participating in the group intervention. Three more groups are planned to begin by the end of May 2000.

PUBLICATIONS AND PRESENTATIONS

Argüelles, S., Argüelles, T., Czaja, S., Eisdorfer, C., Loewenstein, D., Mitrani, V., Rubert, M., & Szapocznik, J. (1998, November). Assisting caregiving families: challenges and new treatments. C. Eisdorfer & S. Czaja (Co-Chairs). Symposium presented in the 51^st Annual Scientific Meeting of the Gerontological Society of America. Philadelphia, PA.

Argüelles, S., Corvea, M., & Rubert, M. (1998, November). Cuban Americans and family therapy: Issues of engagement and treatment. M. Rubert & M. Ory (Organizers), Four Different Interventions with Minority Caregivers: Clinical Issues from the Resources for Enhancing Alzheimer’s Caregiver’s Health (REACH) Project. Symposium conducted at the 51^st Annual Scientific Meeting “The Changing Contexts of Aging: Opportunities and Challenges in the New Millennium” for the Gerontological Society of America. Philadelphia, PA.

Argüelles, S. & Loewenstein, D. (1999, November). The impact of three therapeutic interventions on the caregiver’s perceptions of functional abilities of family members with Alzheimer’s disease. In W. Haley (Discussant), Strategies to Maximize the Efficacy of Caregiver Interventions. Symposium conducted at the 52^nd Annual Scientific Meeting “New Perspectives on Aging in the Post Genome Era” for the Gerontological Society of America. San Francisco, CA.

Argüelles, S. & von Simson, A. (1999). Innovative family and technological interventions for encouraging leisure activities in caregivers of persons with Alzheimer’s disease, Activities, Adaptation, & Aging, 24 (2) 83-97.

Argüelles, S. & Loewenstein, D. (2000, March). Caregiver biases on the functional capacity of Alzheimer’s disease patients. In C. Eisdorfer & S. Czaja (Co-Chairs), Symposium: Strategies to Maximize the Efficacy of Caregiver Interventions. Symposium presented at the AAGP meeting. American Association for Geriatric Psychiatry. Miami, FL.

Argüelles, T. (2000, March). The success of an alternative marketing model in the recruitment of minority subjects into intervention research. In C. Eisdorfer & S. Czaja (Co-Chairs), Symposium: Strategies to Maximize the Efficacy of Caregiver Interventions. Symposium presented at the AAGP meeting. American Association for Geriatric Psychiatry. Miami, FL.

Argüelles, T. (1999, November). The success of an alternative marketing model in the recruitment of minority subjects into intervention research. In C. Eisdorfer & S. Czaja (Co-Chairs), Symposium: Strategies to Maximize the Efficacy of Caregiver Interventions. Symposium presented at the 52^nd Annual Scientific Meeting “New Perspectives on Aging in the Post Genome Era” for the Gerontological Society of America. San Francisco, CA.

Burgio, L. Bourgeois, M., Clark, K., Czaja, S., Gallagher-Thompson, D., Gittlin, L., Kramer, H., Leveck, M., Lichstein, K., Nichols, L., Ory, M., Stevens, S., Szapocznick, J., & Volicer, L. Cross-site comparison of caregiver interventions. Presentation at the Annual meeting of the Gerontological Society of America, 1997.

Burgio, L., Coon, D., Gallagher-Thompson, D., Menéndez, A., Guy, D., Vance, D., Four Different Interventions with Minority Caregivers: Clinical Issues From The Resources For Enhancing Alzheimer’s Caregiver Health (REACH) Project. M. Rubert & M. Ory (Co-Chairs) of a Symposium presented at the 1998 meeting of the Gerontological Society of America.

Burgio, L., Corcoran, M., Lichstein, K.L., Nichols, L., Czaja, S.J., Gallagher-Thompson, D., Bourgeouis, M., Stevens, A., & Ory, M. (Submitted for publication, 2000). Judging outcomes in psychosocial interventions for dementia caregivers: The problem of treatment implementation. The Gerontologist.

Czaja, S. J. (1999, March). The future role of technology in caregiving. Presentation at the 45^th Annual Meeting of the American Society on Aging. Orlando, FL.

Czaja, S.J. (1999, June). Information technology and the future of caregiving. Invited paper presented at the conference on The Next Generation of Caregiving. Las Vegas, NV.

Czaja, S.J. (1999, November). Ethnic differences in symptoms of depression. Paper presented at the 50^th Annual Scientific meeting of the Gerontological Society of America. San Francisco, CA.

Czaja, S.J. (1999, November). Fitting technology to the needs of caregivers. Paper presented at the 50^th Annual Scientific meeting of the Gerontological Society of America. San Francisco, CA.

Czaja, S.J. (2000, March). Family-based interventions for caregivers. Paper presented at the 46^th Annual Meeting of the American Society on Aging. San Diego, California.

Czaja, S.J. (2000, February). Telecommuncations technology as an aid to family caregivers. Invited paper presented at the Human Factors Interventions for the Health Care of Older Adults Conference. Destin, FL.

Czaja, S.J. (Submitted). Technology and family caregiving. In W.A. Rogers and A.D. Fisk (Eds.), Human Factors Interventions for the Health Care of Older Adults. New Jersey: Lawrence Erlbaum Association, Inc.

Czaja, S. J., Eisdorfer, C., and Schulz, R. (2000). Future directions in caregiving: Implications for intervention research. In R. Schulz and M. Ory (Eds.), Handbook on Dementia Caregiving (283-320). New York, NY: Springer Press.

Czaja, S.J., & Rubert, M. (2000, April). Using telecommunications technology to enhance support for family caregivers. Paper presented at the Annual Meeting of the American Association for Geriatric Psychiatry. Miami, FL.

Eisdorfer, C., Czaja, S., Szapocznik, J., Rubert, M., Mitrani, V., Loewenstein, D., Argüelles, S., & Argüelles, T. (1998, December). Family-based interventions for caregivers of Alzheimer’s patients. Poster session presented at the 4^th Annual Departmental Poster Session (Department of Psychiatry and Behavioral Sciences). Miami, FL.

Gallagher-Thompson, D., Arean, P., Menéndez, A., Takagi, K., Argüelles, T., Rubert, M., Loewenstein, D., & Szapocznik, J. (2000). Development and implementation of intervention strategies for culturally diverse caregiving populations. In R. Schulz (Eds.). Handbook on Dementia Caregiving. New York, NY: Springer Publishing Company, Inc.

Lee, Chin Chin (1999, April). The application of statistical optimization techniques to Psychobehavioral interventions. Thesis completed in partial fulfillment of the Masters of Science degree in Industrial Engineering. University of Miami, FL.

Loewenstein, D. A., & Argüelles, S., & Eisdorfer, C. (1999, November). Biased caregiver judgments of functional capacity and the relationship to perceived burden and psychological distress. In W. Haley (Discussant), Strategies to Maximize the Efficacy of Caregiver Interventions. Symposium presented at the 52^nd Annual Scientific Meeting “New Perspectives on Aging in the Post Genome Era” for the Gerontological Society of America. San Francisco, CA.

Mitrani, V.B., & Czaja, S.J. (in press). Family-based therapy for family caregivers: Clinical observations. Journal of Mental Health and Aging.

Rubert, M., Czaja, S., Eisdorfer, C. (November, 1997). The Integration of Technology and Family Therapy. Paper presented at the Annual Meeting of the Gerontological Society of America, Cincinnati, OH.

Rubert, M., Czaja, S.J. (Submitted). Telecommunications technology as an aid to family caregivers of persons with dementia. Rehabilitation Psychology.

Rubert, M., Eisdorfer, C., & Czaja, S. (1996). Family-based interventions for Caregivers. Paper presented at the Annual Meeting of Gerontological Society of America. Washington, DC.

Schulz, R., Gallagher-Thompson, D., Haley, W., & Czaja, S.J. (2000). Understanding the intervention procession: A theoretical/conceptual framework for intervention approaches to caregiving. In R. Schulz and M. Ory (Eds.), Handbook on Dementia Caregiving (33-60). New York, NY: Springer Press.

Schulz, R., Czaja, S.J., & Belle, S. (Submitted). Overview and intervention approaches to family caregiving: Decomposing complex psychosocial interventions. In W.A. Rogers and A.D. Fisk (Eds.), Human Factors Interventions for the Health Care of Older Adults. New Jersey: Lawrence Erlbaum Association, Inc.

Related Publications & Presentations

Argüelles, S. (2000, April). Caring for a family member with Alzheimer’s disease: The Cuban-American experience. The Psychology of Exile: The Cuban-American Experience. Miami, FL.

Argüelles, T. & Loewenstein, D. Recruitment and retention of minority subjects: Discussion of a contemporary conceptual framework. T. Argüelles & C. Eisdorfer (Chair and Discussant), Practical and theoretical subject recruitment and retention. (Symposium submitted to the 2000 meeting of the Gerontological Society of America).

Argüelles, T. The Center for Adult Development and Aging. An Overview of Four New Projects. Invited Presenter at the Florida Coalition on Hispanic Aging (FCHA). Miami, FL (March 21, 2000).

Argüelles, T. Providing Help to a Group of Special and Diverse People. In J. Bruce, M. Bastien, & T. Argüelles, (Symposium). Issues in Diversity: A Mandate for Accommodation. Moderator: Angela Aracena. A regional Alzheimer’s Disease Conference on a Unified Vision of Hope in a Diverse Society” for the Alzheimer’s Association. Davie, FL. (February, 1999).

Argüelles, T. Providing Help to a Group of Special and Diverse People. REACH. Invited presenter in EDU 667, Counseling Special and Diverse Populations, a graduate course in Diversity held at Saint Thomas University. Miami, FL (June 1998, July, 1999).

Argüelles, T. Community Resources - Recursos Comunitarios. Hispanic Caregivers Assistance Program. Wien Center for Alzheimer’s Disease and Memory Disorders. Miami Beach, FL (June 10, 1998).

Argüelles, T. La Salud Mental y la Cultura Hispana (Mental Health and the Hispanic Culture). Facilitando el Manejo del Cuidado en el Hogar. Annual Caregiver Training Seminar for Spanish-speaking Caregivers sponsored by the ADI (Alzheimer’s Disease Initiative). Miami, FL (February 28, 1998).

Argüelles, T., Bravo, M., & Gonzalez, Z. Psychopathology and Lifestyles of the Hispanic Elderly. Hispanic Family Conference. Hispanics 21. “Hispanics moving towards the XXIst Century.” Metro-Dade Department of Human Services. Office of Youth and Family Development. Miami, FL (October 3, 1997).

Eisdorfer, C. Care for the Caregiver. Presented in A regional Alzheimer’s Disease Conference on “A Unified Vision of Hope in a Diverse Society” for the Alzheimer’s Association. Davie, FL. (February, 1999).

Eisdorfer, C., Czaja, S.J., Szapocznik, J., Rubert, M., Mitrani, V., Loewenstein, D., Argüelles, S., & Argüelles, T. (1998, December). Family-based interventions for caregivers of Alzheimer’s patients. Poster session presented at the 4^th Annual Departmental (Psychiatry and Behavioral Sciences) Poster session. Miami, FL.

Schulz, R., Czaja, S.J., & Belle, S. (February, 2000). Alzheimer’s disease caregiving research. Presentation to the NIA. AD Working Group, Bethesda: MD.

VA PALO ALTO HEATLH CARE SYSTEM AND

STANFORD UNIVERSITY SCHOOL OF MEDICINE

Treatment of Distress in Hispanic and Anglo Caregivers

REACH Progress Report

May 2000

Dolores Gallagher-Thompson, Ph.D., Principal Investigator

GOALS OF STUDY

The relevant research literature has demonstrated that providing care for demented family members requires extensive time and labor that often produces significant burden for caregivers. In many cases, this burden drains the family caregiver’s social and psychological resources and leads to the development of substantial emotional distress. The primary goal of the California site’s research project remains the investigation of the relative effectiveness of three psychologically-based approaches to the treatment of distress in Hispanic and Anglo women who are the primary caregivers of demented family members. These three approaches include a psychoeducational class (Coping with Caregiving), and enhanced support group, and a telephone-based minimal support condition.

In addition, this study will extend the theoretical and clinical understanding of the caregiving experience to one group of minority families (the Hispanic family) whose proportion is steadily increasing in this country. The careful study of how Hispanic caregivers respond to their caregiving situations is an important question with policy implications that need to be addressed. As well, knowledge of which interventions help to reduce psychological distress in these women will provide new information relevant for the appropriate care of this group.

This project will contribute to improved scientific knowledge in the field of intervention research in two ways: 1) through rigorous investigation of the comparative effectiveness of three very practical interventions for improved well-being, and 2) through examination of the relationship between specific personal characteristics (e.g., caregiver’s style of handling frustration, and caregiver’s perceived social support) and actual physical and mental health outcomes. The latter, emphasizing how certain individual difference variables affect outcome, is a relatively new focus, with little empirical data that directly pertain to family caregivers. Thus, our project will help to answer the question of who is likely to benefit from which specific intervention. Finally, it provides the opportunity to determine if psychologically-oriented interventions have a discernible impact on the physical health of family caregivers. Such indices as type of psychotropic medications used on a regular basis, and number of hospital visits of the caregiver, will provide valuable information on health status that has been overlooked in comparable studies.

SAMPLE RECRUITMENT AND RETENTION

In designing this intervention project, local REACH staff planned to retain across the project 125 completers per ethnicity, including 25 minimal support group completers, 50 psychoeducational class completers, and 50 support group completers from each self-identified ethnic group. Over a 31-month recruitment period (October 1996 – April 1999), the project staff also set the ambitious goal of enrolling a total of 330 caregivers, which included an additional 40 caregivers per ethnicity (Anglo/White and Hispanic/Latino) beyond the 125 completers to help make up for subject discontinuation. This goal built in a sizeable discontinuation rate of over 24%. Our actual recruitment figures are presented below.

This site developed a thorough recruitment and retention plan that identifies key project staff dedicated to our outreach and recruitment efforts. This staff includes bilingual/bicultural outreach workers, interviewers, and interventionists with graduate training in psychology and/or gerontology. This recruitment plan describes key linkages to organizations from which study participants will be recruited. Publicity materials were designed and media sources were identified during the first two years of this grant to promote outreach, with special attention paid to identifying organizations and linkages that foster recruitment within our local Hispanic communities. In particular, we utilized a group of three highly experienced and respected Hispanic professionals as consultants to develop these key linkages and to assist in the implementation of our recruitment strategies and retention plans. In addition, a community advisory board composed of a diverse group of professionals was established and continued to assist with our recruitment and retention efforts this year. Well over 100 staff presentations were given to provide information on the diagnosis and treatment of dementia and the problems associated with caregiving, with at least half of them given to Hispanic/Latino staff dealing specifically with Latino elders and their families. These, of course, provided additional opportunities to promote Project REACH/ALCANCE. The California project staff also created step-by-step policies and processes for subject screening and referral, and delineated recruitment waves for the life of the project that target specific geographical locales. Key geographical locales include: the San Jose area, San Mateo County, the Davis/Modesto area, South Santa Clara County, San Francisco County, and Monterey County.

The Palo Alto site was “in the field” from October 1996 through April 1999, for a total of 31 months. In order to receive approval to enter the field, we had to complete a variety of tasks in both Spanish and English, including: 1) pilot-testing and translation of all CORE and site-specific interview measures; 2) finalization and translation of all three treatment protocols; 3) certification of staff to perform CORE interviews; 4) training of staff in the site-specific battery of measures, all quality control procedures, and all three interventions; 5) outreach and advertising of the project in both languages in order to generate referrals; 6) recruitment of participants (including pre-screen, screening, and obtaining informed consent); 7) finalization of the randomization procedures to be followed (this was particularly complex because two of the three interventions are group-based, meaning eight individuals who can meet at the same time and place, and who speak the same language, need to be randomized to the same condition before that particular class or support group can begin); and 8) actual implementation of all three types of interventions with appropriately randomized participants. Given all of the above, we ultimately enrolled 42 different subject waves, including 13 Coping with Caregiving classes, 14 Enhanced Support Groups, 11 Minimal Support Conditions, and 4 Assigned Minimal Support Conditions. 30 of these waves have been conducted in English and 12 have been conducted in Spanish.

Recruitment Sources

Caregivers were referred from the community through two linkage systems: 1) contacts within the VA Palo Alto Health Care System (VAPAHCS), and 2) local community contacts outside the VAPAHCS. Both professional and self-referrals were welcomed.

Primary sites (and organizations) within the VAPAHCS include the following:

Stanford/VA Alzheimer’s Diagnostic Resource Center: a center providing comprehensive assessments of individuals with memory problems, as well as information and referral services for these individuals and their family members.

Dementia Consortium: a multidisciplinary group of professionals working with individuals suffering from various dementias. Our program has already been presented to this group, and plans are underway to send group members flyers and a brief summary of the project over the VA e-mail system.

Dementia (Alzheimer’s) Care Program: a program established for veterans diagnosed with Alzheimer’s Disease and/or severe dementia of whatever etiology whose short and long-term memory impairments interfere with social and occupational functioning.

VA Clinic of Monterey: a multidisciplinary team of professionals who provide outpatient medical care to veterans and their families in Monterey, Santa Cruz, and San Benito counties. REACH referral services include social work, neurology, psychiatry, psychology, dermatology, and general medicine.

Primary sites (and organizations) identified through local community contacts include:

Alzheimer’s Association (local chapters): We continue to maintain a healthy working relationship with local Alzheimer’s Association administrators and staff by building a system of mutual information and referral. In addition, the Association hired a multicultural outreach coordinator and a bilingual/bicultural staff member during implementation of the REACH Project. Both posit

	American Indian or Alaskan Native	Asian or Pacific Islander	Black, not of Hispanic Origin	His-panic	White, not of Hispanic Origin	Other or Unknown	Total
Female	1	1	13	2	63	0	80
Male	0	0	3	0	16	1	20
Total	1	1	16	2	79	1	100

Supported by:

National Institute on Aging

National Institute of Nursing Research

REACH Progress Report - Table of Contents

Executive Summary…...………….………………………………………………….…….. 3

Project Timeframe and Accomplishments (1995-2000)

Bethesda, Maryland Bethesda, Maryland Bethesda, Maryland

Community-based Recruitment Sources

Subject Retention

TRANSITION ACTIVITIES/CONTINUITY OF SERVICE

Ancillary Studies

Pilot Study

Related Publications and Presentations

Native

Total

Total

DATA COLLECTION

Ongoing Community Dissemination Activities

REACH Ancillary study

Administrative supplement

Tennstedt, S. Chap 1. The extent and impact of family caregiving.

Carl Eisdorfer, Ph.D., M. D.,Principal Investigator

Entry Criteria

DATA COLLECTION

REACH Progress Report

GOALS OF STUDY

SAMPLE RECRUITMENT AND RETENTION

Recruitment Sources