Telephone Resources and Assistance for Caregivers (TRAC)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Stanford University
Information provided by (Responsible Party):
Carol J Farran, DNSc, RN, FAAN, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT00721383
First received: July 22, 2008
Last updated: September 6, 2012
Last verified: September 2012

July 22, 2008
September 6, 2012
May 2007
February 2013   (final data collection date for primary outcome measure)
self-reported physical activity [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00721383 on ClinicalTrials.gov Archive Site
  • caregiving burden [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • caregiver positive well-being [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • self-reported physical health [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • physical function [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Telephone Resources and Assistance for Caregivers (TRAC)
Clinical Trial to Enhance Caregiver Physical Activity

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Alzheimer's Disease
  • Behavioral: Enhancing Physical Activity Intervention
    Physical activity and caregiver skill-building
    Other Name: EPAI
  • Behavioral: CSBI
    Caregiver skill-building
    Other Name: CSBI
  • Experimental: Treatment
    Physical activity and caregiver skill-building
    Intervention: Behavioral: Enhancing Physical Activity Intervention
  • Active Comparator: Control
    caregiver skill-building
    Intervention: Behavioral: CSBI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
240
February 2013
February 2013   (final data collection date for primary outcome measure)

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
Both
40 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00721383
04092307
Yes
Carol J Farran, DNSc, RN, FAAN, Rush University Medical Center
Rush University Medical Center
Stanford University
Principal Investigator: Carol J Farran, PhD Rush University Medical Center
Rush University Medical Center
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP