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| Sponsor: | National Institute on Aging (NIA) |
|---|---|
| Information provided by: | National Institute on Aging (NIA) |
| ClinicalTrials.gov Identifier: | NCT00362284 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Caregivers Stress Depression |
Behavioral: Enhanced Counseling and Support Behavioral: Usual care |
Phase III |
| Study Type: | Interventional |
| Study Design: | Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Expanded Counseling and Support for Adult Children Caring for Parents With Alzheimer's Disease or Similar Disorders |
| Estimated Enrollment: | 200 |
| Study Start Date: | September 2005 |
| Estimated Study Completion Date: | August 2010 |
| Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Behavioral: Enhanced Counseling and Support
Six individual and family consultation sessions (2 individual, 3 family, 1 individual) within the first 4 months with adult child caregivers; 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
|
| 2: Active Comparator |
Behavioral: Usual care
Usual care; information and referral support if needed
|
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:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Joseph E. Gaugler, PhD | 612-626-2485 | gaug0015@umn.edu |
| United States, Minnesota | |
| University of Minnesota, School of Nursing, 6-150 Weaver-Densford Hall | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Contact: Joseph E. Gaugler, PhD 612-626-2485 gaug0015@umn.edu | |
| Contact: Kristie Kellis, MA 612-625-1601 kell0394@umn.edu | |
| United States, New York | |
| Silberstein Institute for Aging and Dementia, Department of Psychiatry, NYU School of Medicine | Recruiting |
| New York, New York, United States, 10016 | |
| Contact: Mary S. Mittelman, DrPH 212-263-7560 mary.mittelman@med.nyu.edu | |
| Contact: Olanta Barton 212-263-5710 olanta.barton@med.nyu.edu | |
| 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 |
More Information
| Responsible Party: | University of Minnesota ( Joseph E. Gaugler, Ph.D. ) |
| Study ID Numbers: | IA0095, R01 AG022066 |
| Study First Received: | August 8, 2006 |
| Last Updated: | August 6, 2008 |
| ClinicalTrials.gov Identifier: | NCT00362284 History of Changes |
| Health Authority: | United States: Federal Government |
|
Alzheimer's disease coping quality of life caregiving |
|
Depression Alzheimer Disease Nervous System Diseases Central Nervous System Diseases Depressive Disorder Brain Diseases Neurodegenerative Diseases |
Behavioral Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Mood Disorders Dementia Tauopathies |