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NCT03759873 · ClinicalTrials.gov registry record · Phase 2
Incentives and Case Management to Improve Cardiac Care: Healthy Lifestyle Program
A Phase 2 study, sponsored by University of Vermont.
- Completed
- Registry status
- Phase 2
- Development phase
- 209
- Enrollment target
NCT03759873 is a Phase 2 study that has completed, run by University of Vermont. The registered enrollment target is 209 participants.
The verdict
NCT03759873, a Phase 2 study, has completed, sponsored by University of Vermont.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 209 participants
- Enrollment target
Study Summary
Participation in outpatient cardiac rehabilitation (CR) decreases morbidity and mortality for patients hospitalized with myocardial infarction, coronary bypass surgery or percutaneous revascularization. Unfortunately, only 10-35% of patients for whom CR is indicated choose to participate. Lower socioeconomic status (SES) is a robust predictor of CR non-participation. There is growing recognition of the need to increase CR among economically disadvantaged patients, but there are almost no evidence-based interventions available for doing so. The present study will examine the efficacy of using early case management and financial incentives for increasing CR participation among lower-SES patients. Case management has been effective at promoting attendance at a variety of health-related programs (e.g. treatment for diabetes, HIV, asthma, cocaine dependence) as well as reducing hospitalizations. Financial incentives are also highly effective in altering health behaviors among disadvantaged populations (e.g., smoking during pregnancy, weight loss) including CR participation in a prior trial. For this study 209 CR-eligible lower-SES patients will be randomized to: a treatment condition where patients are assigned a case manager while in hospital who will facilitate CR attendance and coordinate cardiac care, a treatment condition where patients receive financial incentives contingent on initiation of and continued attendance at CR sessions, a combination of these two interventions, or to a "usual-care" condition. Participants in all conditions will complete pre- and post-treatment assessments. Treatment conditions will be compared on attendance at CR and end-of-intervention improvements in fitness, executive function, and health-related quality of life. Cost effectiveness of the treatment conditions will also be examined by comparing the costs of delivering the interventions and the usual care condition, taking into account increases in CR participation. Furthermore, the va
Interventions
- BEHAVIORAL Case Management
- BEHAVIORAL Incentives
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 209 participants |
| Start Date | 2018-12-03 |
| Est. Completion | 2024-02-28 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03759873
The ClinicalTrials.gov registry entry for NCT03759873 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 209 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Vermont, which has 162 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Case Management is the first listed.
NCT03759873 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03759873 about?
NCT03759873 is a clinical study titled "Incentives and Case Management to Improve Cardiac Care: Healthy Lifestyle Program". Participation in outpatient cardiac rehabilitation (CR) decreases morbidity and mortality for patients hospitalized with myocardial infarction, coronary bypass surgery or percutaneous revascularization. Unfortunately, only 10-35% of patients for whom CR is indicated choose to participate. Lower soci...
What is the current status of trial NCT03759873?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 209 participants. The study started on 2018-12-03. Estimated completion is 2024-02-28.
What interventions are being tested in trial NCT03759873?
The interventions under investigation include: Case Management (BEHAVIORAL), Incentives (BEHAVIORAL).
Who is sponsoring clinical trial NCT03759873?
This trial is sponsored by University of Vermont, which has 162 total clinical trials registered on ClinicalTrials.gov.
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