Telephone Resources and Assistance for Caregivers (TRAC) (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.

Study Overview

• Status: Completed
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Behavioral: Enhancing Physical Activity Intervention; Behavioral: CSBI

• Study Type: Interventional
• Enrollment (Actual): 211
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Physical activity and caregiver skill-building	Behavioral: Enhancing Physical Activity Intervention; Physical activity and caregiver skill-building; Other Names: EPAI
Active Comparator: Control; caregiver skill-building	Behavioral: CSBI; Caregiver skill-building

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
self-reported physical activity	18 months

Secondary Outcome Measures

Outcome Measure	Time Frame
caregiving burden	18 months
caregiver positive well-being	18 months
self-reported physical health	18 months
physical function	18 months

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Collaborators: Stanford University
• Investigators: Principal Investigator: Carol J Farran, PhD, Rush University Medical Center

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: July 22, 2008
• First Submitted That Met QC Criteria: July 23, 2008
• First Posted (Estimate): July 24, 2008

Study Record Updates

• Last Update Posted (Estimate): December 31, 2014
• Last Update Submitted That Met QC Criteria: December 30, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: caregiving, Alzheimer's disease, physical activity
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: 04092307