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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00721383
Recruitment Status : Completed
First Posted : July 24, 2008
Last Update Posted : December 31, 2014
Stanford University
Information provided by (Responsible Party):
Carol J Farran, DNSc, RN, FAAN, Rush University Medical Center

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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Behavioral: Enhancing Physical Activity Intervention Behavioral: CSBI Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 211 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Clinical Trial to Enhance Caregiver Physical Activity
Study Start Date : May 2007
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Arm Intervention/treatment
Experimental: Treatment
Physical activity and caregiver skill-building
Behavioral: Enhancing Physical Activity Intervention
Physical activity and caregiver skill-building
Other Name: EPAI
Active Comparator: Control
caregiver skill-building
Behavioral: CSBI
Caregiver skill-building

Primary Outcome Measures :
  1. self-reported physical activity [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. caregiving burden [ Time Frame: 18 months ]
  2. caregiver positive well-being [ Time Frame: 18 months ]
  3. self-reported physical health [ Time Frame: 18 months ]
  4. physical function [ Time Frame: 18 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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


  • 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


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

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 identifier (NCT number): NCT00721383

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Stanford University
Principal Investigator: Carol J Farran, PhD Rush University Medical Center

Responsible Party: Carol J Farran, DNSc, RN, FAAN, MD, Rush University Medical Center Identifier: NCT00721383     History of Changes
Other Study ID Numbers: 04092307
First Posted: July 24, 2008    Key Record Dates
Last Update Posted: December 31, 2014
Last Verified: December 2014

Keywords provided by Carol J Farran, DNSc, RN, FAAN, Rush University Medical Center:
caregiving, Alzheimer's disease, physical activity

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders