Telephone Resources and Assistance for Caregivers (TRAC)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Rush University Medical Center.
Recruitment status was  Active, not recruiting
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
  Purpose

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 Intervention
Alzheimer's Disease
Behavioral: Enhancing Physical Activity Intervention
Behavioral: CSBI

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Clinical Trial to Enhance Caregiver Physical Activity

Resource links provided by NLM:


Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:
  • self-reported physical activity [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 240
Study Start Date: May 2007
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: CSBI

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  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: NCT00721383

Locations
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
Investigators
Principal Investigator: Carol J Farran, PhD Rush University Medical Center
  More Information

No publications provided

Responsible Party: Carol J Farran, DNSc, RN, FAAN, MD, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT00721383     History of Changes
Other Study ID Numbers: 04092307
Study First Received: July 22, 2008
Last Updated: September 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Rush University Medical Center:
caregiving, Alzheimer's disease, physical activity

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

ClinicalTrials.gov processed this record on October 19, 2014