Coordinating Center for Enhancing ADRD Caregiving

Sponsor

University of Pittsburgh (Other)

Overall Status

Completed

CT.gov ID

NCT00178165

Collaborator

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

1,200

Enrollment

Locations

Duration (Months)

240

Patients Per Site

3.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Dementia Alzheimer Disease	Procedure: Skill Training Condition - problem solving training Procedure: REACH for TLC (Telephone Linked Computer) system	N/A

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 Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Coordinating Center for Enhancing Alzheimer Disease and Related Disorder Caregiving

Study Start Date :

Sep 1, 1996

Study Completion Date :

Nov 1, 2001

Outcome Measures

Primary Outcome Measures

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

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

CORE CARE RECIPIENT INCLUSION/EXCLUSION CRITERIA

Inclusion criteria:

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

Exclusion criteria:

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

CORE CAREGIVER INCLUSION/EXCLUSION CRITERIA

Inclusion criteria:

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

Exclusion criteria:

Any terminal illness with life expectancy < 6 months
Active treatment (chemotherapy, radiation therapy) for cancer
More than three acute medical hospitalizations in past year
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294-2041
2	Stanford University and Veterans Affairs	Menlo Park	California	United States	94025
3	University of Miami at Miami, Center on Adult Development and Aging	Miami	Florida	United States	33136
4	Thomas Jefferson University at Philadelphia, Center for Applied Research on Aging and Health	Philadelphia	Pennsylvania	United States	19107
5	University of Tennessee Health Science Center	Memphis	Tennessee	United States	38163

Sponsors and Collaborators

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

Investigators

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