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Comprehensive Support for Alzheimer’s Disease Caregivers

This study is currently recruiting participants.
Verified by National Institute on Aging (NIA), June 2007

Sponsored by: 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
Phase III

MedlinePlus related topics:   Alzheimer's Caregivers   Alzheimer's Disease   Caregivers   Dementia   Depression   Nursing Homes   Stress  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Other, Randomized, Single Blind, 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

Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:
  • Care recipient nursing home/institutional placement
  • caregiver emotional stress
  • caregiver depression
  • caregiver social support

Secondary Outcome Measures:
  • Caregiver subjective health
  • secondary stressors

Estimated Enrollment:   200
Study Start Date:   September 2005
Estimated Study Completion Date:   July 2010

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.
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00362284

Contacts
Contact: Joseph E. Gaugler, PhD     612-626-2485     gaug0015@umn.edu    

Locations
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    

Sponsors and 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    
  More Information

Publications:

Study ID Numbers:   IA0095, R01 AG022066
First Received:   August 8, 2006
Last Updated:   June 13, 2007
ClinicalTrials.gov Identifier:   NCT00362284
Health Authority:   United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
Alzheimer's disease  
coping  
quality of life  
caregiving  

Study placed in the following topic categories:
Delirium, Dementia, Amnestic, Cognitive Disorders
Depression
Alzheimer Disease
Quality of Life
Central Nervous System Diseases
Stress
Neurodegenerative Diseases
Brain Diseases
Dementia
Depressive Disorder
Cognition Disorders
Delirium

Additional relevant MeSH terms:
Mental Disorders
Nervous System Diseases
Tauopathies
Behavioral Symptoms

ClinicalTrials.gov processed this record on July 03, 2008




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