Telephone Resources and Assistance for Caregivers (TRAC) - Full Text View

Sponsors and Collaborators:	Rush University Medical Center Stanford University
Information provided by:	Rush University Medical Center
ClinicalTrials.gov Identifier:	NCT00721383

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

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Caregivers Alzheimer's Disease Caregivers Dementia Mental Health

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment
Official Title:	Clinical Trial to Enhance Caregiver Physical Activity

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 Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Treatment: Experimental Physical activity and caregiver skill-building	Behavioral: Enhancing Physical Activity Intervention Physical activity and caregiver skill-building
Control: Active Comparator caregiver skill-building	Behavioral: CSBI Caregiver skill-building

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 (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
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 (Lewy body, multi-infarct, stroke, Pick's, 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
Active treatment for cancer
Live more than 60 miles round-trip from the medical center

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00721383

Contacts

Contact: Caryn D Etkin, PhD	(312) 942-5242	Caryn_Etkin@rush.edu
Contact: Diane Marston, PhD	(312) 942-4396	Diane_Marston@rush.edu

Locations

United States, California
Stanford University School of Medicine	Active, not recruiting
Stanford, California, United States, 94305
United States, Illinois
Rush University Medical Center	Recruiting
Chicago, Illinois, United States, 60612
Sub-Investigator: Judy J McCann, PhD

Sponsors and Collaborators

Rush University Medical Center

Stanford University

Investigators

Principal Investigator:

Carol J Farran, PhD

Rush University Medical Center

More Information

Responsible Party:	Rush University Medical Center ( Carol J. Farran )
Study ID Numbers:	04092307
Study First Received:	July 22, 2008
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00721383
Health Authority:	United States: Institutional Review Board

Keywords provided by Rush University Medical Center:

caregiving, Alzheimer's disease, physical activity

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases

Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Nervous System Diseases
Tauopathies

ClinicalTrials.gov processed this record on January 16, 2009