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NCT00721383 · ClinicalTrials.gov registry record · NA
Telephone Resources and Assistance for Caregivers (TRAC)
A NA study, sponsored by Rush University Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 211
- Enrollment target
NCT00721383 is a NA study that has completed, run by Rush University Medical Center. The registered enrollment target is 211 participants.
The verdict
NCT00721383, a NA study, has completed, sponsored by Rush University Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 211 participants
- Enrollment target
Study 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 suppor
Interventions
- BEHAVIORAL Enhancing Physical Activity Intervention
- BEHAVIORAL CSBI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 211 participants |
| Start Date | 2007-05 |
| Est. Completion | 2013-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00721383
The ClinicalTrials.gov registry entry for NCT00721383 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 211 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rush University Medical Center, which has 320 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Enhancing Physical Activity Intervention is the first listed.
NCT00721383 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00721383 about?
NCT00721383 is a clinical study titled "Telephone Resources and Assistance for Caregivers (TRAC)". 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 t...
What is the current status of trial NCT00721383?
This trial is currently completed. It is a NA study. The enrollment target is 211 participants. The study started on 2007-05. Estimated completion is 2013-02.
What interventions are being tested in trial NCT00721383?
The interventions under investigation include: Enhancing Physical Activity Intervention (BEHAVIORAL), CSBI (BEHAVIORAL).
Who is sponsoring clinical trial NCT00721383?
This trial is sponsored by Rush University Medical Center, which has 320 total clinical trials registered on ClinicalTrials.gov.
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