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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| National Institute of Nursing Research (NINR) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | 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. |
|
| Control | Other | Caregivers in the control group received 2 brief "check-in" telphone calls during the 6 month intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| multicomponent psychosocial intervention | Behavioral | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Caregiver clinical depression and patient institutional placement-six months post-randomization. | six months |
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Caregiver Inclusion/Exclusion Criteria:
Inclusion Criteria:
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*
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:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Schulz, Ph.D. | Professor of Psychiatry and Director, University Center for Social and Urban Research, University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294-2041 | United States | ||
| Stanford University and Veterans Affairs |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17116917 | Result | Belle SH, Burgio L, Burns R, Coon D, Czaja SJ, Gallagher-Thompson D, Gitlin LN, Klinger J, Koepke KM, Lee CC, Martindale-Adams J, Nichols L, Schulz R, Stahl S, Stevens A, Winter L, Zhang S; Resources for Enhancing Alzheimer's Caregiver Health (REACH) II Investigators. Enhancing the quality of life of dementia caregivers from different ethnic or racial groups: a randomized, controlled trial. Ann Intern Med. 2006 Nov 21;145(10):727-38. doi: 10.7326/0003-4819-145-10-200611210-00005. | |
| 21391405 |
| Label | URL |
|---|---|
| REACH II website- click here for more information about this study | View source |
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There is no plan to make individual participant data available.
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| ID | Term |
|---|---|
| D003704 | Dementia |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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| Control arm | Other | Caregivers in the control group received 2 brief "check-in" telephone calls during the 6-month intervention. |
|
| Menlo Park |
| California |
| 94025 |
| United States |
| University of Miami at Miami, Center on Adult Development and Aging | Miami | Florida | 33136 | United States |
| Thomas Jefferson University at Philadelphia, Center for Applied Research on Aging and Health | Philadelphia | Pennsylvania | 19107 | United States |
| University of Tennessee Health Science Center | Memphis | Tennessee | 38163 | United States |
| Derived |
| Nichols LO, Martindale-Adams J, Burns R, Graney MJ, Zuber J. Typical and atypical dementia family caregivers: systematic and objective comparisons. Int J Aging Hum Dev. 2011;72(1):27-43. doi: 10.2190/AG.72.1.b. |
| 20122038 | Derived | Elliott AF, Burgio LD, Decoster J. Enhancing caregiver health: findings from the resources for enhancing Alzheimer's caregiver health II intervention. J Am Geriatr Soc. 2010 Jan;58(1):30-7. doi: 10.1111/j.1532-5415.2009.02631.x. |
| D001523 | Mental Disorders |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |