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Clinical Trial 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 value of the interventions will be modeled based on increases in participation rates, intervention costs, long-term medical costs, and health outcomes after a coronary event. This systematic examination of promising interventions will allow testing of the efficacy and cost-effectiveness of approaches that have the potential to substantially increase CR participation and significantly improve health outcomes among lower-SES cardiac patients.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03759873
Study type Interventional
Source University of Vermont
Contact
Status Completed
Phase Phase 2
Start date December 3, 2018
Completion date February 28, 2024

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