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Sponsors and Collaborators: |
University of Pittsburgh National Institute on Aging (NIA) National Institute of Nursing Research (NINR) |
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Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00177489 |
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.
Condition | Intervention |
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Dementia Alzheimer Disease |
Procedure: multicomponent psychosocial intervention |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Coordinating Center for Multisite Intervention Trial for Diverse Caregivers |
Estimated Enrollment: | 600 |
Study Start Date: | June 2002 |
Estimated Study Completion Date: | August 2004 |
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.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Inclusion Criteria:
Exclusion Criteria:
SPMSQ:> or = 4 errors*
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:
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 |
Study ID Numbers: | AG13305, AG13289, AG13313, AG20277, AG13265, NR004261 |
Study First Received: | September 12, 2005 |
Last Updated: | September 12, 2005 |
ClinicalTrials.gov Identifier: | NCT00177489 |
Health Authority: | United States: Federal Government |
Family Caregivers Dementia Alzheimer Disease Randomized Controlled Trial Intervention Studies |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Alzheimer Disease Central Nervous System Diseases Neurodegenerative Diseases |
Brain Diseases Dementia Cognition Disorders Delirium |
Nervous System Diseases Tauopathies |