Coordinating Center for Caregiver Intervention Trial
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Purpose
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 |
|---|---|
|
Dementia Alzheimer Disease |
Procedure: multicomponent psychosocial intervention |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Coordinating Center for Multisite Intervention Trial for Diverse Caregivers |
- multivariate quality of life indicator- assessed caregiver burden, depressive symptoms, self-care, social support and patient problem behaviors. Assessed at six months post-randomization.
- Caregiver clinical depression and patient institutional placement-six months post-randomization.
| 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.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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
Contacts and Locations| 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 |
More Information
Additional Information:
No publications provided by University of Pittsburgh
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00177489 History of Changes |
| Other Study ID Numbers: | AG13305, AG13289, AG13313, AG20277, AG13265, NR004261 |
| Study First Received: | September 12, 2005 |
| Last Updated: | September 12, 2005 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Pittsburgh:
|
Family Caregivers Dementia Alzheimer Disease Randomized Controlled Trial Intervention Studies |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013