| August 8, 2006 |
| August 6, 2008 |
| September 2005 |
| August 2010 (final data collection date for 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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- Care recipient nursing home/institutional placement
- caregiver emotional stress
- caregiver depression
- caregiver social support
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| Complete list of historical versions of study NCT00362284 on ClinicalTrials.gov Archive Site |
- 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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- Caregiver subjective health
- secondary stressors
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| |
| Comprehensive Support for Alzheimer's Disease Caregivers |
| Expanded Counseling and Support for Adult Children Caring for Parents With Alzheimer's Disease or Similar Disorders |
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. |
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:
- Adult child caregivers in the treatment conditions of the University of Minnesota (UM) and NYU-ADRC will report similar decreases on measures of stress when compared to usual-contact controls;
- Adult child caregivers in the intervention conditions at both sites will develop improved social support resources and experience significantly greater decreases of family conflict in a similar manner;
- Adult child caregivers in the treatment conditions at UM and NYU-ADRC will report similar decreases on global measures of psychological distress, such as depression. Similarly, treatment caregivers will report greater increases in subjective health than their counterparts in the usual-contact control; and
- Membership in the treatment condition of the ECS and its benefits (e.g., increased social support, decreased stress) will lead to delayed institutionalization (e.g., nursing home placement) of care recipients at the UM and NYU-ADC sites.
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| Phase III |
| Interventional |
| Other, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
- Caregivers
- Stress
- Depression
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- Behavioral: Enhanced Counseling and Support
- Behavioral: Usual care
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| |
- Mittelman MS, Ferris SH, Shulman E, Steinberg G, Ambinder A, Mackell JA, Cohen J. A comprehensive support program: effect on depression in spouse-caregivers of AD patients. Gerontologist. 1995 Dec;35(6):792-802.
- Mittelman MS, Ferris SH, Steinberg G, Shulman E, Mackell JA, Ambinder A, Cohen J. An intervention that delays institutionalization of Alzheimer's disease patients: treatment of spouse-caregivers. Gerontologist. 1993 Dec;33(6):730-40.
- Mittelman MS, Ferris SH, Shulman E, Steinberg G, Levin B. A family intervention to delay nursing home placement of patients with Alzheimer disease. A randomized controlled trial. JAMA. 1996 Dec 4;276(21):1725-31.
- Mittelman MS, Roth DL, Coon DW, Haley WE. Sustained benefit of supportive intervention for depressive symptoms in caregivers of patients with Alzheimer's disease. Am J Psychiatry. 2004 May;161(5):850-6.
- Mittelman MS, Roth DL, Haley WE, Zarit SH. Effects of a caregiver intervention on negative caregiver appraisals of behavior problems in patients with Alzheimer's disease: results of a randomized trial. J Gerontol B Psychol Sci Soc Sci. 2004 Jan;59(1):P27-34.
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| |
| Recruiting |
| 200 |
| August 2010 |
| August 2010 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Participant (i.e., adult child) must be the 'primary' caregiver of the patient with a diagnosis of dementia (i.e., the first person called if the patient is in need of help) at the time of the baseline interview
- Must be a daughter, son, daughter-in-law, or son-in-law of the patient
- Patient must live in the community (i.e., at home, with the caregiver, with other relatives)
- Sees the individual with dementia once a week or more
Exclusion Criteria:
- Unable to understand or speak English comfortably
- Inadequate hearing
- Unwilling to participate in the study or sign the consent form
- Suffered from or received treatment for an emotional or psychological disorder, such as depression, anxiety, or some other type of psychotic episode, within the past 6 months
- Not physically able to participate
- Received counseling for problems arising as a caregiver
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| Both |
| 18 Years and older |
| Yes |
|
|
| United States |
| |
| NCT00362284 |
| Joseph E. Gaugler, Ph.D., University of Minnesota |
| IA0095, R01 AG022066 |
| National Institute on Aging (NIA) |
|
| Principal Investigator: |
Joseph E. Gaugler, PhD |
University of Minnesota, Center on Aging, Center for Gerontological Nursing, School of Nursing |
|
| Principal Investigator: |
Mary Mittelman, DrPH |
Silberstein Institute for Aging and Dementia, Department of Psychiatry, NYU School of Medicine |
|
|
| National Institute on Aging (NIA) |
| August 2008 |