Increasing Cardiac Rehabilitation Participation Among Medicaid Enrollees

NCT ID: NCT02172820

Last Updated: 2019-06-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2018-02-28

Brief Summary

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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. Medicaid coverage and similar state-supported insurance are robust predictors of CR non-participation. There is growing recognition of the need to increase CR among patients with this form of insurance and other economically disadvantaged patients, but there are no evidence-based interventions available for doing so. In the present study we are examining the efficacy of using financial incentives for increasing CR participation among Medicaid patients. Financial incentives have been highly effective in altering other health behaviors among disadvantaged populations (e.g., smoking during pregnancy, weight loss). For this study are randomizing 130 CR-eligible Medicaid enrollees to a treatment condition where they receive financial incentives contingent on initiation of and continued attendance at CR sessions or to a "usual-care" condition where they will not receive these incentives. Treatment conditions will be compared on attendance at CR and end-of-intervention improvements in fitness, decision making and health-related quality of life. Cost effectiveness of the treatment conditions will also be examined by comparing the costs of the incentive intervention and usual care conditions with their effects on increasing CR initiation and adherence. Should this intervention be efficacious and cost-effective, it has the potential to substantially increase CR participation and significantly improve health outcomes among low-income cardiac patients.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Financial incentives

Participants receive financial incentives for completing exercise sessions.

Group Type EXPERIMENTAL

Financial incentives

Intervention Type BEHAVIORAL

Patients in the experimental group will receive financial incentives for completing exercise sessions.

Control

Participants receive an equal amount of clinical contact but no financial incentives for completing exercise visits.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Financial incentives

Patients in the experimental group will receive financial incentives for completing exercise sessions.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* A recent myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft, heart valve replacement or repair, or stable heart failure.
* Enrolled in a state-supported insurance plan for low income individuals
* Lives in and plans to remain in the greater Burlington, Vermont area (Chittenden County) for the next 12 mos.

Exclusion Criteria

* Dementia (MMSE\<20) or current untreated Axis 1 psychiatric disorder other than nicotine dependence as determined by medical history
* Non-English speaking
* Prior participation in cardiac rehabilitation
* Advanced cancer, advanced frailty, or other longevity-limiting systemic disease that would preclude CR participation
* Rest angina or very low threshold angina (\<2 METS) until adequate therapy is instituted
* Severe life threatening ventricular arrhythmias unless adequately controlled (e.g. intracardiac defibrillator)
* Class 4 chronic heart failure (symptoms at rest)
* Exercise-limiting non-cardiac disease such as severe arthritis, past stroke, severe lung disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role collaborator

University of Vermont

OTHER

Sponsor Role lead

Responsible Party

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Diann Gaalema

Assistant Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Vermont

Burlington, Vermont, United States

Site Status

Countries

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United States

References

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Gaalema DE, Elliott RJ, Savage PD, Rengo JL, Cutler AY, Pericot-Valverde I, Priest JS, Shepard DS, Higgins ST, Ades PA. Financial Incentives to Increase Cardiac Rehabilitation Participation Among Low-Socioeconomic Status Patients: A Randomized Clinical Trial. JACC Heart Fail. 2019 Jul;7(7):537-546. doi: 10.1016/j.jchf.2018.12.008. Epub 2019 May 8.

Reference Type DERIVED
PMID: 31078475 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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P20GM103644

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CRINCN9874

Identifier Type: -

Identifier Source: org_study_id

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