Coordinating Center for Enhancing ADRD Caregiving

September 13, 2005 updated by: University of Pittsburgh

Coordinating Center for Enhancing Alzheimer Disease and Related Disorder Caregiving

Established in 1995, Resources for Enhancing Alzheimer's Caregiver Health (REACH) is a unique, multi-site research program sponsored by the National Institute on Aging (NIA) and the National Institute on Nursing Research (NINR). The primary purpose of REACH is to carry out social and behavioral research on interventions designed to enhance family caregiving for Alzheimer's disease and related disorders. Specifically, REACH has two goals: to test the effectiveness of multiple different interventions and to evaluate the pooled effect of REACH interventions overall. REACH grew out of a National Institute of Health (NIH) initiative that acknowledged the well-documented burdens associated with family caregiving as well as the existence of promising family caregiver interventions reported in the literature.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Six sites (Boston, Birmingham, Memphis, Miami, Palo Alto, and Philadelphia) developed and evaluated a variety of multi-component interventions for family caregivers of persons with Alzheimer's Disease (AD) at the mild or moderate level of impairment. The multi-component interventions implemented across the six sites included: 1) Individual Information and Support strategies, 2) Group Support and Family Systems therapy, 3) Psychoeducational and Skill-based Training approaches, 4) Home-based Environmental interventions,, and 5) Enhanced Technology Support Systems. Although the interventions were derived from diverse theoretical models, they are all consistent with basic health-stress models in which the goal is to change the nature of specific stressors (e.g. problem behavior of the care recipient), their appraisal, and/or the caregivers response to the stressors. All of the REACH interventions were guided by detailed treatment manuals and certification procedures that assured that the interventions were delivered consistently over time at each site. Careful attention was also paid to the issue of treatment integrity. Different strategies were used at each site to induce and assess all three fundamental aspects of treatment integrity: delivery, receipt, and enactment (Burgio, et al., 2001). In addition, because the caregiving experience in race and ethnic minority families is particularly neglected in the field, there was a strong emphasis placed on the inclusion of African American and Hispanic caregivers. Thus, assessments as well as interventions were tailored at each site to meet the needs of culturally diverse racial/ethnic majority and minority populations.

All of the REACH sites shared several common goals, including: 1) designing theory-driven caregiving interventions to test hypotheses about intervention processes and their effect on family caregivers, 2) specifying intervention components that help us understand the pathways through which interventions produce desired outcomes, 3) developing a standardized outcome protocol to assess the impact of different strategies on caregivers and their care recipients within each site and across sites, and 4) creating a common database that would facilitate pooling data across sites. In addition, standard selection criteria were adopted by REACH.

Although REACH has some of the features of a traditional multi-site randomized controlled clinical trial (e.g., random assignment of participants to treatment and control conditions, common database and outcome measures, and identical measurement intervals across sites), it differs on one key dimension-the interventions varied across sites. REACH was designed to examine the feasibility and outcomes of multiple different intervention approaches, rather than to provide definitive information on the efficacy of one specific intervention strategy for enhancing caregiver outcomes. The strength of this approach is that it efficiently yields information about the effectiveness of different approaches to AD caregiving as well as the combined effects of active treatment versus controls, as reported in the planned meta-analysis.

REACH successfully randomized 1222 caregiver/care recipient dyads representing both majority and minority populations to 15 different conditions.

Study Type

Interventional

Enrollment

1200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-2041
        • University of Alabama at Birmingham
    • California
      • Menlo Park, California, United States, 94025
        • Stanford University and Veterans Affairs
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami at Miami, Center on Adult Development and Aging
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University at Philadelphia, Center for Applied Research on Aging and Health
    • Tennessee
      • Memphis, Tennessee, United States, 38163
        • University of Tennessee Health Science Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

CORE CARE RECIPIENT INCLUSION/EXCLUSION CRITERIA

Inclusion criteria:

  1. NINCDS -ADRDA Criteria for Alzheimer's Disease and/or DSM IV Criteria for Alzheimer's Disease or other dementia or MMSE score < 23.
  2. Functional impairment: presence of two IADL or one ADL impairments.

Exclusion criteria:

  1. Any terminal illness with life expectancy < 6 months
  2. Active treatment (chemotherapy, radiation therapy) for cancer
  3. More than three acute medical hospitalizations in past year (not for psychiatric or Alzheimer's Disease related admission)
  4. Schizophrenia (onset of delusions before age 45)
  5. Dementia secondary to head trauma (probable)
  6. Blindness or deafness if either disability prohibits them from completion of data collection or participation in the interventions
  7. MMSE = 0 and bedbound (confined to a bed or chair for > 22 hours per day, for at least 4 of the past 7 days)
  8. Planned nursing home admission in 6 months

CORE CAREGIVER INCLUSION/EXCLUSION CRITERIA

Inclusion criteria:

  1. Age: 21 years and older
  2. Language: site specific, must be competent either orally or written
  3. Lives with care recipient
  4. Family member
  5. Gender: Palo Alto/Los Angeles will only enroll women. All other sites will enroll men and women
  6. Must have a telephone
  7. At enrollment, plan to remain in area for the duration of the intervention and follow-up
  8. Caregiver role of at least 6 months
  9. Provides > 4 hours of supervision or direct assistance per day for the care recipient

Exclusion criteria:

  1. Any terminal illness with life expectancy < 6 months
  2. Active treatment (chemotherapy, radiation therapy) for cancer
  3. More than three acute medical hospitalizations in past year
  4. Involved in another clinical trial of interventions for caregivers (non drug study)

Second Level Review If the caregiver has been inconsistent with answers or repeated answers, then the interviewer will administer the SPMSQ. The interviewer will then discuss with the PI and coordinate another phone call with the caregiver.

If in the course of the telephone screen the research assistant believes that there may be difficulties for the caregiver regarding travel arrangements, hesitancy to answer questions, or other specific items (site-specific indications), the research assistant will refer to the PI for review.

All potential caregivers will receive a follow-up phone call for second level exclusion from the trial when appropriate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The outcomes were assessed 6 months after randomization and included a measure of burden and a measure of depression. Caregiver burden was assessed using the Revised Memory and Behavior Problem Checklist (RMBPC).
Emotional distress was determined by the Center for Epidemiological Studies Depression Scale (CES-D) a global measure of depression.

Secondary Outcome Measures

Outcome Measure
Long-term care placement of dementia patients and caregiver health and well-being
Use of cognitive enhancement medication
Clinical significance of caregiver interventions in diverse populations

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

National Institute of Nursing Research (NINR)
National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Richard Schulz, Ph.D., Professor of Psychiatry and Director, University Center for Social and Urban Research, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1996

Study Completion

November 1, 2001

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

September 15, 2005

Last Update Submitted That Met QC Criteria

September 13, 2005

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AG13305-01
  • NR13269
  • AG13313
  • AG13297
  • AG13289
  • AG13265
  • AG13255
  • AG13305

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dementia

Clinical Trials on Skill Training Condition - problem solving training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Dominican Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe