Telephone Resources and Assistance for Caregivers (TRAC)

NCT00721383 | Completed DMC

• 1 other identifier: 04092307
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 2

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.

Conditions

Alzheimer's Disease

Keywords

caregiving, Alzheimer's disease, physical activity

Outcome Measures

Primary Outcomes (1)

• self-reported physical activity

  18 months

Secondary Outcomes (4)

• caregiving burden

  18 months

• caregiver positive well-being

  18 months

• self-reported physical health

  18 months

• physical function

  18 months

Study Arms (2)

Treatment

EXPERIMENTAL

Physical activity and caregiver skill-building

Behavioral: Enhancing Physical Activity Intervention

Control

ACTIVE COMPARATOR

caregiver skill-building

Behavioral: CSBI

Interventions

Enhancing Physical Activity Intervention BEHAVIORAL

Physical activity and caregiver skill-building

Also known as: EPAI

Treatment

CSBI BEHAVIORAL

Caregiver skill-building

Control

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead
• Stanford University: collaborator

Study Sites (2)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Motor Activity

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Behavior

Study Officials

• Carol J Farran, PhD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 22, 2008
• First Posted: July 24, 2008
• Study Start: May 1, 2007
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: December 31, 2014

Record last verified: 2014-12

Locations

US (2)