Coordinating Center for Caregiver Intervention Trial (REACH)

January 4, 2016 updated by: Richard Schulz, University of Pittsburgh

Coordinating Center for Multisite Intervention Trial for Diverse Caregivers

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

613

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alabama
      • Birmingham, Alabama, United States, 35294-2041
        • University of Alabama at Birmingham
    • California
      • Menlo Park, California, United States, 94025
        • Stanford University and Veterans Affairs
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami at Miami, Center on Adult Development and Aging
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University at Philadelphia, Center for Applied Research on Aging and Health
    • Tennessee
      • Memphis, Tennessee, United States, 38163
        • University of Tennessee Health Science Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Caregiver Inclusion/Exclusion 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
The intervention addressed caregiver depression, burden, self-care, and social support and care recipient problem behaviors through 12 in-home and telephone sessions over 6 months.
The intervention addressed caregiver depression, burden, self-care, and social support and care recipient problem behaviors through 12 in-home and telephone sessions over 6 months.
Other: Control
Caregivers in the control group received 2 brief "check-in" telphone calls during the 6 month intervention.
Caregivers in the control group received 2 brief "check-in" telephone calls during the 6-month intervention.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Caregiver clinical depression and patient institutional placement-six months post-randomization.
Time Frame: six months
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Richard Schulz, Ph.D., Professor of Psychiatry and Director, University Center for Social and Urban Research, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2002

Primary Completion (Actual)

September 1, 2005

Study Completion (Actual)

September 1, 2005

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

January 5, 2016

Last Update Submitted That Met QC Criteria

January 4, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

There is no plan to make individual participant data available.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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