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Comprehensive Support for Alzheimer's Disease Caregivers

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ClinicalTrials.gov Identifier: NCT00362284
Recruitment Status : Completed
First Posted : August 9, 2006
Last Update Posted : February 11, 2022
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of Minnesota

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.

Condition or disease Intervention/treatment Phase
Caregivers Stress Depression Behavioral: NYUCI-AC Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 161 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
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

Arm Intervention/treatment
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.
Behavioral: NYUCI-AC
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.

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. caregiver depression [ Time Frame: baseline, 4, 8, 12, and 18 months; 24, 30, 36 months if possible ]
    The Geriatric Depression Scale.

  4. 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.

Secondary Outcome Measures :
  1. 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.

  2. secondary stressors [ Time Frame: baseline, 4, 8, 12, and 18 months; 24, 30, 36 months if possible ]
    Measures of family and role conflict.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00362284

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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
Sponsors and Collaborators
University of Minnesota
National Institute on Aging (NIA)
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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
Publications of Results:
Other Publications:
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT00362284    
Other Study ID Numbers: H13355B
R01AG022066 ( U.S. NIH Grant/Contract )
First Posted: August 9, 2006    Key Record Dates
Last Update Posted: February 11, 2022
Last Verified: February 2022
Keywords provided by University of Minnesota:
Alzheimer's disease
quality of life
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders