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Comprehensive Support for Alzheimer's Disease Caregivers

This study is currently recruiting participants.
Study NCT00362284.   Last updated on August 6, 2008.   Information provided by National Institute on Aging (NIA)

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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.

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:

  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.
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 ]
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 ]
Condition  Caregivers
Stress
Depression
Intervention  Behavioral: Enhanced Counseling and Support
Behavioral: Usual care
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:

  • 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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers Yes
Contacts ††
Contact: Joseph E. Gaugler, PhD     612-626-2485     gaug0015@umn.edu    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00362284
Organization ID IA0095
Secondary IDs †† R01 AG022066
Study Sponsor  National Institute on Aging (NIA)
Collaborators ††
Investigators 
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    
Information Provided By National Institute on Aging (NIA)
Verification Date August 2008
First Received Date  August 8, 2006
Last Updated Date August 6, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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