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Completed Phase 2 Interventional Results available

Incentives and Case Management to Improve Cardiac Care: Healthy Lifestyle Program

ClinicalTrials.gov ID: NCT03759873

Public ClinicalTrials.gov record NCT03759873. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 12:42 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Improving Participation in Cardiac Rehabilitation Among Lower-Socioeconomic Status Patients: Efficacy of Early Case Management and Financial Incentives

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03759873
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
University of Vermont
Other
Enrollment
209 participants

Conditions and interventions

Interventions

Behavioral

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 2, 2018
Primary completion
Apr 30, 2023
Completion
Feb 27, 2024
Last update posted
Oct 8, 2024

2018 – 2024

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
University of Vermont Medical Center Burlington Vermont 05405

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03759873, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 8, 2024 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03759873 live on ClinicalTrials.gov.

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