Coordinating Center for Multisite Intervention Trial for Diverse Caregivers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pittsburgh
- Enrollment
- 613
- Locations
- 10
- Primary Endpoint
- multivariate quality of life indicator- assessed caregiver burden, depressive symptoms, self-care, social support and patient problem behaviors. Assessed at six months post-randomization.
Study Overview
Brief Summary
The primary goal of this study is to test a single multi-component intervention among family caregivers of persons with Alzheimer's disease or related disorders. The overall objectives of study are to 1) identify and reduce modifiable risk factors among diverse family caregivers of patients with Alzheimer's Disease or a related disorder, 2) enhance the quality of care of the care recipients, and 3) enhance the well-being of the caregivers.
Detailed Description
The proposed Coordinating Center (CC) will work with five sites and staff from the National Institute on Aging (NIA) and the National Institute of Nursing Research (NINR) to implement a multi-site caregiver intervention trial. The overall objective of this research program is to refine and test a multicomponent psychosocial intervention to reduce burden and depression among family caregivers of persons with Alzheimer's Disease or a related disorder. This competing renewal will build upon results obtained from its parent multi-site feasibility study, Resources for Enhancing Alzheimer's Caregiver Health (REACH) funded by the NIA/NINR as a cooperative agreement (UO1-AG13305). In the study proposed here, five intervention sites (Birmingham, Memphis, Miami, Palo Alto, and Philadelphia) will recruit 600 (120 per site) caregiver-care recipient dyads consisting of equal numbers of African Americans/Blacks, Hispanics/Latinos, and Caucasians/Whites. Caregivers will be randomized to either an in-home multicomponent intervention condition or a standardized information-only control condition.
The Coordinating Center at the University of Pittsburgh will work with the intervention site investigators and the NIA/NINR to support the implementation of the intervention study at each site and to collect and analyze a common database across sites.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age: 21 years or older
- •Family member of the care recipient
- •Must live with care recipient or share cooking facilities
- •Must have a telephone that will enable use of CTIS (Computer Telephone Integration System) system
- •Must plan to remain in the recruitment area for the duration of the intervention and follow-up
- •Caregiver role for more than 6 months
- •Must provide on average 4 hours of supervision or direct assistance per day for the care recipient
- •Risk Screening Tool: must have a total score of at least 1 for questions 1-3, and a total of at least 2 for questions 4-9
Exclusion Criteria
- •Non-English, non-Spanish speaking
- •Active treatment (chemotherapy, radiation therapy) for cancer
- •Imminent placement of care recipient into a nursing home or with another caregiver (within 6 months)
- •Involvement in another clinical trial for caregivers
- •Participant in REACH I study
- •SPMSQ:> or = 4 errors*
- •If the caregiver has been inconsistent with answers or repeated answers during the screening process, then the interviewer administers the Short Portable Mental Status Questionnaire (SPMSQ). If the caregiver missed 4 or more questions, he/she was excluded from the study.
- •Care Recipient Inclusion/Exclusion Criteria
- •Inclusion Criteria:
- •a. NINCDS (MD diagnosis) of dementia or cognitive impairment (raw score on MMSE of 23 or less)
- •Exclusion Criteria:
- •Non-English, non-Spanish speaking
- •History of Parkinson's Disease or a stroke with no reported decline in memory over the past year
- •Active treatment (chemotherapy, radiation therapy) for cancer
- •More than three acute medical hospitalizations in past year (other than psychiatric or Alzheimer's Disease related admission)
- •Schizophrenia (onset of delusions before age 45) or other severe mental illness
- •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
- •Participant in REACH I study
Outcomes
Primary Outcomes
multivariate quality of life indicator- assessed caregiver burden, depressive symptoms, self-care, social support and patient problem behaviors. Assessed at six months post-randomization.
Time Frame: six months
Secondary Outcomes
- Caregiver clinical depression and patient institutional placement-six months post-randomization.(six months)
Investigators
Richard Schulz
Professor of Psychiatry
University of Pittsburgh