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Comprehensive Support for Alzheimer's Disease Caregivers
This study is currently recruiting participants.
Study NCT00362284   Information provided by National Institute on Aging (NIA)
First Received: August 8, 2006   Last Updated: August 6, 2008   History of Changes

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 ]
  • Care recipient nursing home/institutional placement
  • caregiver emotional stress
  • caregiver depression
  • caregiver social support
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 ]
  • Caregiver subjective health
  • secondary stressors
 
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:

  1. 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;
  2. 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;
  3. 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
  4. 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.
Phase III
Interventional
Other, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
  • Caregivers
  • Stress
  • Depression
  • Behavioral: Enhanced Counseling and Support
  • Behavioral: Usual care
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
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
Both
18 Years and older
Yes
Contact: Joseph E. Gaugler, PhD 612-626-2485 gaug0015@umn.edu
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP