Coordinating Center for Caregiver Intervention Trial

This study has been completed.
Sponsor:
Collaborators:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00177489
First received: September 12, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

The primary goal of this study is to test a single multi-component intervention among family caregivers of persons with Alzheimer’s disease or related disorders. The overall objectives of study are to 1) identify and reduce modifiable risk factors among diverse family caregivers of patients with Alzheimer’s Disease or a related disorder, 2) enhance the quality of care of the care recipients, and 3) enhance the well-being of the caregivers.


Condition Intervention
Dementia
Alzheimer Disease
Procedure: multicomponent psychosocial intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Coordinating Center for Multisite Intervention Trial for Diverse Caregivers

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • multivariate quality of life indicator- assessed caregiver burden, depressive symptoms, self-care, social support and patient problem behaviors. Assessed at six months post-randomization.

Secondary Outcome Measures:
  • Caregiver clinical depression and patient institutional placement-six months post-randomization.

Estimated Enrollment: 600
Study Start Date: June 2002
Estimated Study Completion Date: August 2004
Detailed Description:

The proposed Coordinating Center (CC) will work with five sites and staff from the National Institute on Aging (NIA) and the National Institute of Nursing Research (NINR) to implement a multi-site caregiver intervention trial. The overall objective of this research program is to refine and test a multicomponent psychosocial intervention to reduce burden and depression among family caregivers of persons with Alzheimer's Disease or a related disorder. This competing renewal will build upon results obtained from its parent multi-site feasibility study, Resources for Enhancing Alzheimer’s Caregiver Health (REACH) funded by the NIA/NINR as a cooperative agreement (UO1-AG13305). In the study proposed here, five intervention sites (Birmingham, Memphis, Miami, Palo Alto, and Philadelphia) will recruit 600 (120 per site) caregiver-care recipient dyads consisting of equal numbers of African Americans/Blacks, Hispanics/Latinos, and Caucasians/Whites. Caregivers will be randomized to either an in-home multicomponent intervention condition or a standardized information-only control condition.

The Coordinating Center at the University of Pittsburgh will work with the intervention site investigators and the NIA/NINR to support the implementation of the intervention study at each site and to collect and analyze a common database across sites.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inclusion Criteria:

    1. Age: 21 years or older
    2. Family member of the care recipient
    3. Must live with care recipient or share cooking facilities
    4. Must have a telephone that will enable use of CTIS (Computer Telephone Integration System) system
    5. Must plan to remain in the recruitment area for the duration of the intervention and follow-up
    6. Caregiver role for more than 6 months
    7. Must provide on average 4 hours of supervision or direct assistance per day for the care recipient
    8. Risk Screening Tool: must have a total score of at least 1 for questions 1-3, and a total of at least 2 for questions 4-9

Exclusion Criteria:

  1. Non-English, non-Spanish speaking
  2. Active treatment (chemotherapy, radiation therapy) for cancer
  3. Imminent placement of care recipient into a nursing home or with another caregiver (within 6 months)
  4. Involvement in another clinical trial for caregivers
  5. Participant in REACH I study
  6. SPMSQ:> or = 4 errors*

    • If the caregiver has been inconsistent with answers or repeated answers during the screening process, then the interviewer administers the Short Portable Mental Status Questionnaire (SPMSQ). If the caregiver missed 4 or more questions, he/she was excluded from the study.

Care Recipient Inclusion/Exclusion Criteria

Inclusion Criteria:

a. NINCDS (MD diagnosis) of dementia or cognitive impairment (raw score on MMSE of 23 or less)

Exclusion Criteria:

  1. Non-English, non-Spanish speaking
  2. History of Parkinson’s Disease or a stroke with no reported decline in memory over the past year
  3. Active treatment (chemotherapy, radiation therapy) for cancer
  4. More than three acute medical hospitalizations in past year (other than psychiatric or Alzheimer’s Disease related admission)
  5. Schizophrenia (onset of delusions before age 45) or other severe mental illness
  6. Dementia secondary to head trauma (probable)
  7. Blindness or deafness if either disability prohibits them from completion of data collection or participation in the interventions
  8. MMSE = 0 and Bedbound (confined to a bed or chair for  22 hours per day, for at least 4 of the past 7 days)
  9. Planned nursing home admission in 6 months
  10. Participant in REACH I study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00177489

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-2041
United States, California
Stanford University and Veterans Affairs
Menlo Park, California, United States, 94025
United States, Florida
University of Miami at Miami, Center on Adult Development and Aging
Miami, Florida, United States, 33136
United States, Pennsylvania
Thomas Jefferson University at Philadelphia, Center for Applied Research on Aging and Health
Philadelphia, Pennsylvania, United States, 19107
United States, Tennessee
University of Tennessee Health Science Center
Memphis, Tennessee, United States, 38163
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Richard Schulz, Ph.D. Professor of Psychiatry and Director, University Center for Social and Urban Research, University of Pittsburgh
  More Information

Additional Information:
No publications provided by University of Pittsburgh

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00177489     History of Changes
Other Study ID Numbers: AG13305, AG13289, AG13313, AG20277, AG13265, NR004261
Study First Received: September 12, 2005
Last Updated: September 12, 2005
Health Authority: United States: Federal Government

Keywords provided by University of Pittsburgh:
Family Caregivers
Dementia
Alzheimer Disease
Randomized Controlled Trial
Intervention Studies

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on October 23, 2014