Coordinating Center for Caregiver Intervention Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Coordinating Center for Multisite Intervention Trial for Diverse Caregivers

Conditions
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Dementia, Alzheimer Disease

Intervention / Treatment
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* Behavioral: multicomponent psychosocial intervention
* Other: Control arm


Participation Criteria
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Eligibility Criteria
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Caregiver Inclusion/Exclusion 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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>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. | Behavioral: multicomponent psychosocial intervention<br>* 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.<br>|
| Other: Control<br>Caregivers in the control group received 2 brief check-in telphone calls during the 6 month intervention. | Other: Control arm<br>* Caregivers in the control group received 2 brief check-in telephone calls during the 6-month intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caregiver clinical depression and patient institutional placement-six months post-randomization. |  | six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Family Caregivers, Dementia, Alzheimer Disease, Randomized Controlled Trial, Intervention Studies