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| Descriptive Information Fields | |||||||||
| Brief Title † | Comprehensive Support for Alzheimer's Disease Caregivers | ||||||||
| Official Title † | Expanded Counseling and Support for Adult Children Caring for Parents With Alzheimer's Disease or Similar Disorders | ||||||||
| Brief Summary | The purpose of this study is to determine the effectiveness of a comprehensive counseling and support intervention for people who care for parents with Alzheimer's disease (AD) or other dementias on outcomes such as stress, depression and ability to postpone or avoid nursing home placement. |
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| Detailed Description | Although a range of studies have examined the stress and depression of family caregivers of persons suffering from dementia, the effectiveness of psychosocial interventions to assist caregiving families and their disabled elderly relatives is uncertain. The comprehensive support protocol to be implemented, the Enhanced Counseling and Support (ECS) program, has been successfully implemented at the Silberstein Aging and Dementia Research Center of New York University School of Medicine (NYU-ADRC) over the past 19 years. However, the initial evaluation of the ECS was limited to a single geographic area (New York City proper) and a specific type of dementia caregiver (spouses). The specific aims of this 4-year project are as follows: 1) Examine whether the ECS can achieve positive outcomes for adult child caregivers. Few psychosocial interventions are directed specifically at adult child caregivers, and evaluating the ECS in adult child caregiving situations, which few studies have done, will further demonstrate the effectiveness of this program and add considerably to the AD caregiver intervention literature; and 2) Determine if the ECS, an intervention of proven efficacy for AD caregivers in a northern U.S. urban community (New York City), will also be effective in alleviating negative outcomes among AD caregivers at a Midwestern project site. The study will ascertain whether the comprehensive support program developed at NYU is generalizable to caregivers from areas other than the New York City area and leads to similar benefits that are maintained over long periods of time (i.e., up to 3.5 years). In order to accomplish the specific aims of the project, the following study hypotheses have been proposed:
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| Study Phase | Phase III | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Other, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | Care recipient nursing home/institutional placement [ Time Frame: baseline, 4, 8, 12, and 18 months; 24, 30, 36 months if possible ] [ Designated as safety issue: No ] caregiver emotional stress [ Time Frame: baseline, 4, 8, 12, and 18 months; 24, 30, 36 months if possible ] [ Designated as safety issue: No ] caregiver depression [ Time Frame: baseline, 4, 8, 12, and 18 months; 24, 30, 36 months if possible ] [ Designated as safety issue: No ] caregiver social support [ Time Frame: baseline, 4, 8, 12, and 18 months; 24, 30, 36 months if possible ] [ Designated as safety issue: No ] |
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| Secondary Outcome Measure † | Caregiver subjective health [ Time Frame: baseline, 4, 8, 12, and 18 months; 24, 30, 36 months if possible ] [ Designated as safety issue: No ] secondary stressors [ Time Frame: baseline, 4, 8, 12, and 18 months; 24, 30, 36 months if possible ] [ Designated as safety issue: No ] |
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| Condition † | Caregivers Stress Depression |
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| Intervention † | Behavioral: Enhanced Counseling and Support Behavioral: Usual care |
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| MEDLINE PMIDs | 8557206, 8314099, 8940320, 15121650, 14722336 | ||||||||
| Links | |||||||||
| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 200 | ||||||||
| Start Date † | September 2005 | ||||||||
| Completion Date | August 2010 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00362284 | ||||||||
| Organization ID | IA0095 | ||||||||
| Secondary IDs †† | R01 AG022066 | ||||||||
| Study Sponsor † | National Institute on Aging (NIA) | ||||||||
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| Investigators † |
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| Information Provided By | National Institute on Aging (NIA) | ||||||||
| Verification Date | August 2008 | ||||||||
| First Received Date † | August 8, 2006 | ||||||||
| Last Updated Date | August 6, 2008 | ||||||||