Alzheimer Disease, Dementia
Conditions
Keywords
Family Caregivers, Dementia, Alzheimer Disease, Randomized Controlled Trial, Intervention Studies
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.
Interventions
BEHAVIORALmulticomponent psychosocial intervention
The intervention addressed caregiver depression, burden, self-care, and social support and care recipient problem behaviors through 12 in-home and telephone sessions over 6 months.
OTHERControl arm
Caregivers in the control group received 2 brief check-in telephone calls during the 6-month intervention.
Sponsors
National Institute on Aging (NIA)
National Institute of Nursing Research (NINR)
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Caregiver Inclusion/
Exclusion criteria
* Inclusion Criteria: 1. Age: 21 years or older 2. Family member of the care recipient 3. Must live with care recipient or share cooking facilities 4. Must have a telephone that will enable use of CTIS (Computer Telephone Integration System) system 5. Must plan to remain in the recruitment area for the duration of the intervention and follow-up 6. Caregiver role for more than 6 months 7. Must provide on average 4 hours of supervision or direct assistance per day for the care recipient 8. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| multivariate quality of life indicator- assessed caregiver burden, depressive symptoms, self-care, social support and patient problem behaviors. Assessed at six months post-randomization. | six months |
Secondary
| Measure | Time frame |
|---|---|
| Caregiver clinical depression and patient institutional placement-six months post-randomization. | six months |
Countries
United States
Outcome results
None listed