Comprehensive Support for Alzheimer's Disease Caregivers
|ClinicalTrials.gov Identifier: NCT00362284|
Recruitment Status : Completed
First Posted : August 9, 2006
Last Update Posted : May 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Caregivers Stress Depression||Behavioral: NYUCI-AC||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||161 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Expanded Counseling and Support for Adult Children Caring for Parents With Alzheimer's Disease or Similar Disorders|
|Study Start Date :||September 2005|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||January 2012|
U.S. FDA Resources
Experimental: NYUCI-AC group
Adult children in this arm received the NYUCI-AC intervention, which consisted of 6 individual and family counseling sessions, the offering of an adult child specific support group, and the provision of ad hoc, or ongoing, consultation throughout the duration of participation.
Approximately six individual and family consultation sessions (2 individual, 3 family, 1 individual) within the first 4 months with adult child caregivers and/or their family members; support group participation (recommended at least once a month) after the completion of the individual and family consultation sessions for the duration of the project (up to 3 years after the intake interview); ad hoc consultation (ongoing in-person, telephone, or email support on an as-needed basis) for the duration of the project (up to 3 years after the intake interview); New York University Caregiver Intervention
No Intervention: Usual care control
Adult children randomly assigned to the usual care control did not receive the NYUCI-AC intervention. If they were in crisis or required support, the NYUCI-AC counselors provided information and referral on an as-needed basis.
- Care recipient nursing home/institutional placement [ Time Frame: baseline, 4, 8, 12, and 18 months; 24, 30, 36 months if possible ]Adult child caregivers self-reported whether the care recipient was admitted to a residential care setting and the date of admission.
- Caregiver emotional stress [ Time Frame: baseline, 4, 8, 12, and 18 months; 24, 30, 36 months if possible ]Measures of role captivity, role overload, and general perceived stress.
- caregiver depression [ Time Frame: baseline, 4, 8, 12, and 18 months; 24, 30, 36 months if possible ]The Geriatric Depression Scale.
- caregiver social support [ Time Frame: baseline, 4, 8, 12, and 18 months; 24, 30, 36 months if possible ]Three single items that measured perceptions of support received by the adult child caregiver.
- Caregiver subjective health [ Time Frame: baseline, 4, 8, 12, and 18 months; 24, 30, 36 months if possible ]Single item self-reported health as well as measures derived from the OARS.
- secondary stressors [ Time Frame: baseline, 4, 8, 12, and 18 months; 24, 30, 36 months if possible ]Measures of family and role conflict.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00362284
|United States, Minnesota|
|University of Minnesota, School of Nursing, 6-150 Weaver-Densford Hall|
|Minneapolis, Minnesota, United States, 55455|
|United States, New York|
|Silberstein Institute for Aging and Dementia, Department of Psychiatry, NYU School of Medicine|
|New York, New York, United States, 10016|
|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|