Increasing Cardiac Rehabilitation Participation Among Medicaid Enrollees

May 21, 2019 updated by: Diann Gaalema, University of Vermont
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Vermont
      • Burlington, Vermont, United States, 05401
        • University of Vermont

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Financial incentives
Participants receive financial incentives for completing exercise sessions.
Behavioral: Financial incentives
Patients in the experimental group will receive financial incentives for completing exercise sessions.
No Intervention: Control
Participants receive an equal amount of clinical contact but no financial incentives for completing exercise visits.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Attendance at Cardiac Rehabilitation Exercise Sessions
Time Frame: Within 4 months of initial stress test
The number of patients who completed cardiac rehabilitation (CR) as defined as greater than or equal to 30 sessions. Must have been completed within 4 months of the entry stress test.
Within 4 months of initial stress test

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Physical Health
Time Frame: Intake, 4 months
Secondary outcomes included changes between baseline and 4-month assessment in fitness (peak oxygen uptake directly measured by expired gas analysis or estimated by metabolic equivalents), body composition (body mass index, waist circumference), and quality of life (MacNew).The MacNew was designed to evaluate how daily activities and physical,emotional and social functioning are affected by heart disease and its treatment. It consists of 27 questions grouped into 3 domains: physical, mental and social functioning. Both subscales and summary score are interpreted as scores between 1 and 7; higher scores are better, and a change of at least 0.5 is a useful indicator of the minimal important difference.Changes over time were assessed using paired differences in scores from intake to four months. Due to non-normal distributions, Wilcoxon Signed Rank Test was used. Contributions of other variables to changes in secondary outcomes were examined using analyses of covariance.
Intake, 4 months
Changes in Mental Health/Cognition
Time Frame: Changes in socio-cognitive measures will be measures from intake to completion of intervention (4 months)
The Achenbach System of Empirically Based Assessment (ASEABA) is an integrated system of multi-informant assessments, including self-reports, to measure adaptive functioning and problems. The problem items have been factor-analytically reduced to 8 syndrome scales that are consistent across age, informant and culture. Higher scores represent higher symptoms (e.g. emotional/behavioral problems). The Stop Signal Reaction Time (SSRT) task measures the ability to inhibit incorrect responses. Lower scores represent a better ability to inhibit reactions. The BRIEF-A is a rating scale developed to look at everyday behaviors associated with specific domains of executive functions in adults ages 18-90.T-scores (standardized scores) are used to interpret the individual's level of executive functioning (EF). Higher scores represent more self-reported problems. A score of 50 represents the mean.A difference of 10 from the mean indicates a difference of one standard deviation (SD).
Changes in socio-cognitive measures will be measures from intake to completion of intervention (4 months)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maintenance of Physical Health Gains Following Intervention.
Time Frame: 4 months and 1 year.
Changes in measures of physical health and fitness (peak oxygen uptake, metabolic equivalents, waist circumference, BMI, treadmill time, smoking status, perceived quality of life) will be measured from completion of intervention (4 months) to 8 months later (1 year follow-up).
4 months and 1 year.
Maintenance of Mental Health/Cognition Scores Following Intervention.
Time Frame: 4 months and 1 year.
Changes in measures of mental health (Beck Depression Inventory, Adult Self-Report) as well as changes in measures of executive function (Trail Making and Tower tasks, Delay Discounting, Time Perspective Questionnaire, Stop Signal Task, Behavior Rating Inventory of Executive Function) will be measured from completion of intervention (4 months) to 8 months later (1 year follow-up).
4 months and 1 year.
Health Care Costs
Time Frame: From intake to one year follow-up
Health care costs (cost of delivering care at the cardiac rehabilitation clinic as well as hospital costs) will be calculated from study entry to one year follow-up.
From intake to one year follow-up
Costs of Attending Care
Time Frame: Intake to 1 year follow-up
Costs to the patient of attending care (transportation, child/elder care, missed wages) will be calculated from study entry to one year follow-up.
Intake to 1 year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Vermont

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of General Medical Sciences (NIGMS)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CRINCN9874
  • P20GM103644 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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