Coordinating Center for Enhancing ADRD Caregiving
|ClinicalTrials.gov Identifier: NCT00178165|
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : September 15, 2005
|Condition or disease||Intervention/treatment|
|Dementia Alzheimer Disease||Procedure: Skill Training Condition – problem solving training Procedure: REACH for TLC (Telephone Linked Computer) system|
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 (Clinical Trial)|
|Estimated Enrollment :||1200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Coordinating Center for Enhancing Alzheimer Disease and Related Disorder Caregiving|
|Study Start Date :||September 1996|
|Estimated Study Completion Date :||November 2001|
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00178165
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294-2041|
|United States, California|
|Stanford University and Veterans Affairs|
|Menlo Park, California, United States, 94025|
|United States, Florida|
|University of Miami at Miami, Center on Adult Development and Aging|
|Miami, Florida, United States, 33136|
|United States, Pennsylvania|
|Thomas Jefferson University at Philadelphia, Center for Applied Research on Aging and Health|
|Philadelphia, Pennsylvania, United States, 19107|
|United States, Tennessee|
|University of Tennessee Health Science Center|
|Memphis, Tennessee, United States, 38163|
|Principal Investigator:||Richard Schulz, Ph.D.||Professor of Psychiatry and Director, University Center for Social and Urban Research, University of Pittsburgh|