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NCT04113057 · ClinicalTrials.gov registry record · NA
Home-based Walking Program With Smart Devices
A NA study, sponsored by Dallas VA Medical Center.
- Terminated
- Registry status
- NA
- Development phase
- 12
- Enrollment target
NCT04113057 is a NA study that was terminated before completion, run by Dallas VA Medical Center. The registered enrollment target is 12 participants.
The verdict
NCT04113057, a NA study, was terminated before completion, sponsored by Dallas VA Medical Center.
- TERMINATED
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
Study Summary
Intermittent claudication (IC), the most common manifestation of peripheral artery disease (PAD), represents not only a significant detriment in quality of life, but also an increased risk for atherosclerotic cardiovascular disease (ASCVD), including progression of PAD, coronary artery disease (CAD) and cerebrovascular disease. Guideline directed therapy for IC includes supervised exercise, smoking cessation and optimal medical management to decrease overall risk of ASCVD. In the VA Health Care System, implementation of supervised exercise therapy through cardiac rehabilitation or physical therapy programs is limited by distances that patients must travel to VA facilities that provide these services. Furthermore, one of the most common failure points in exercise therapy programs is poor patient compliance. Improved patient participation and compliance in exercise programs for IC represents an unmet need, without which the majority of patients with life-style limiting PAD may not be receiving optimal medical management. Small studies have demonstrated the effectiveness of home-based exercise programs as an alternative to supervised exercise therapy; however, the success of the home-based exercise programs require remote coaching and/or regular provider feedback. The wide-spread availability of smart phones and smart devices has accelerated the implementation of telehealth programs that may supplement or may eventually replace in-person encounters for health care delivery. The role of provider feedback in addition to real-time feedback from smart devices remains completely unexplored. Our central hypothesis is that in individuals with IC, regular provider feedback on smart-device-based remote health monitoring data, which is available to the patient in real time, will augment the benefits of home-based exercise programs. We propose a randomized trial in patients with IC to test the central hypothesis through two Specific Aims: 1. To determine the effect of provider
Interventions
- OTHER Remote Coaching
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2019-08-09 |
| Est. Completion | 2021-05-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04113057
The ClinicalTrials.gov registry entry for NCT04113057 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dallas VA Medical Center, which has 20 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Remote Coaching is the first listed.
NCT04113057 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04113057 about?
NCT04113057 is a clinical study titled "Home-based Walking Program With Smart Devices". Intermittent claudication (IC), the most common manifestation of peripheral artery disease (PAD), represents not only a significant detriment in quality of life, but also an increased risk for atherosclerotic cardiovascular disease (ASCVD), including progression of PAD, coronary artery disease (CAD)...
What is the current status of trial NCT04113057?
This trial is currently terminated. It is a NA study. The enrollment target is 12 participants. The study started on 2019-08-09. Estimated completion is 2021-05-31.
What interventions are being tested in trial NCT04113057?
The interventions under investigation include: Remote Coaching (OTHER).
Who is sponsoring clinical trial NCT04113057?
This trial is sponsored by Dallas VA Medical Center, which has 20 total clinical trials registered on ClinicalTrials.gov.
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