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Telephone Resources and Assistance for Caregivers (TRAC) (TRAC)

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enhancing Physical Activity Intervention
CSBI
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alzheimer's Disease focused on measuring caregiving, Alzheimer's disease, physical activity

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Care recipient:

  • Diagnosis of probable AD or related dementia (using NINCDS/ADA criteria)
  • Reside in the community
  • Receive assistance from a primary caregiver

Caregiver:

  • Are a spouse or other close family member of the person with AD/dementia
  • Age ≥ 40 years
  • English-speaking
  • Live with the care recipient (or close as in 5-10 miles)
  • Provide ≥ 10 hours of care per week
  • Caregiver for at least 6 months
  • Are physically inactive, defined as accumulating ≤ 60 minutes of regular PA on a weekly basis for the past 6 months
  • Reporting some to moderate levels of strain
  • Are cognitively intact
  • Have no major debilitating health problems that would prevent intervention participation
  • Must have a telephone
  • Willing to increase levels of physical activity
  • Agree to assignment of treatment condition

Exclusion Criteria:

Care receiver:

  • Other dementias such as stroke or Parkinson's
  • Terminal illness with life expectancy of less than six months
  • Bedfast or confined to a bed or chair at least 22 hours a day for at least 3 of the previous 7 days
  • ≥ 3 acute or medical or psychiatric hospitalizations in last year

Caregiver:

  • Are involved in another caregiver clinical trial
  • Have a terminal illness with life expectancy of less than 6 months
  • Receiving active treatment for cancer

Sites / Locations

  • Stanford University School of Medicine
  • Rush University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment

Control

Arm Description

Physical activity and caregiver skill-building

caregiver skill-building

Outcomes

Primary Outcome Measures

self-reported physical activity

Secondary Outcome Measures

caregiving burden
caregiver positive well-being
self-reported physical health
physical function

Full Information

First Posted
July 22, 2008
Last Updated
December 30, 2014
Sponsor
Rush University Medical Center
Collaborators
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT00721383
Brief Title
Telephone Resources and Assistance for Caregivers (TRAC)
Acronym
TRAC
Official Title
Clinical Trial to Enhance Caregiver Physical Activity
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rush University Medical Center
Collaborators
Stanford University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this randomized clinical trial is to test a 12-month multi-component health promotion intervention with home-based family caregivers of persons with Alzheimer's Disease and other related dementias. Specific aims are to: 1) Test the primary hypothesis: The Enhancing Physical Activity treatment intervention will be more effective in increasing caregiver lifestyle physical activity than the Standard Care Intervention; 2) Test secondary hypotheses: The Enhancing Physical Activity treatment intervention will be more effective than the Standard Care Intervention in improving the following caregiver secondary outcomes: mental health, physical health and physical function; and 3) Evaluate the process of implementing a lifestyle physical activity intervention with family caregivers. The Standard Care Intervention focuses on well-established care-related education and support needs. The Enhancing Physical Activity treatment intervention focuses on two areas: increasing lifestyle physical activity and addressing well-established care-related concerns that are likely to interfere with increasing physical activity. A total of 190 middle-age to older community-based primary caregivers of persons with Alzheimer's disease or other related dementias who report some to moderate strain with caregiving activities will be randomly assigned to either the Enhancing Physical Activity or Standard Care Intervention. Data will be collected at baseline, 3, 6, 9, 12 and 18 months and include self-report and direct observational methods. Data will be analyzed by using repeated measures models using the generalized estimating equation approach. Family caregivers are a stressed population who experience changes in their mental and physical health. However, effect sizes have been minimal for interventions designed to only affect caregiver mental health. No study known to us, has tested the added value of physical activity adoption in conjunction with more traditional caregiver support and skill building. Study findings will enable us to evaluate the behavioral , physical, and health-related quality of life effects achieved by the combined intervention; and will add knowledge about the most effective ways of intervening with family caregivers and other chronically stressed middle-age and older adult populations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
caregiving, Alzheimer's disease, physical activity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
211 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Physical activity and caregiver skill-building
Arm Title
Control
Arm Type
Active Comparator
Arm Description
caregiver skill-building
Intervention Type
Behavioral
Intervention Name(s)
Enhancing Physical Activity Intervention
Other Intervention Name(s)
EPAI
Intervention Description
Physical activity and caregiver skill-building
Intervention Type
Behavioral
Intervention Name(s)
CSBI
Intervention Description
Caregiver skill-building
Primary Outcome Measure Information:
Title
self-reported physical activity
Time Frame
18 months
Secondary Outcome Measure Information:
Title
caregiving burden
Time Frame
18 months
Title
caregiver positive well-being
Time Frame
18 months
Title
self-reported physical health
Time Frame
18 months
Title
physical function
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Care recipient: Diagnosis of probable AD or related dementia (using NINCDS/ADA criteria) Reside in the community Receive assistance from a primary caregiver Caregiver: Are a spouse or other close family member of the person with AD/dementia Age ≥ 40 years English-speaking Live with the care recipient (or close as in 5-10 miles) Provide ≥ 10 hours of care per week Caregiver for at least 6 months Are physically inactive, defined as accumulating ≤ 60 minutes of regular PA on a weekly basis for the past 6 months Reporting some to moderate levels of strain Are cognitively intact Have no major debilitating health problems that would prevent intervention participation Must have a telephone Willing to increase levels of physical activity Agree to assignment of treatment condition Exclusion Criteria: Care receiver: Other dementias such as stroke or Parkinson's Terminal illness with life expectancy of less than six months Bedfast or confined to a bed or chair at least 22 hours a day for at least 3 of the previous 7 days ≥ 3 acute or medical or psychiatric hospitalizations in last year Caregiver: Are involved in another caregiver clinical trial Have a terminal illness with life expectancy of less than 6 months Receiving active treatment for cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol J Farran, PhD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Telephone Resources and Assistance for Caregivers (TRAC)

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