Increasing Cardiac Rehabilitation Participation Among Medicaid Enrollees
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Financial incentives
Sponsored by

About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring cardiac rehabilitation, contingency management
Eligibility Criteria
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
Sites / Locations
- University of Vermont
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Financial incentives
Control
Arm Description
Participants receive financial incentives for completing exercise sessions.
Participants receive an equal amount of clinical contact but no financial incentives for completing exercise visits.
Outcomes
Primary Outcome Measures
Attendance at Cardiac Rehabilitation Exercise Sessions
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.
Secondary Outcome Measures
Change in Physical Health
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.
Changes in Mental Health/Cognition
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).
Full Information
NCT ID
NCT02172820
First Posted
June 20, 2014
Last Updated
May 21, 2019
Sponsor
University of Vermont
Collaborators
National Institute of General Medical Sciences (NIGMS)
1. Study Identification
Unique Protocol Identification Number
NCT02172820
Brief Title
Increasing Cardiac Rehabilitation Participation Among Medicaid Enrollees
Official Title
Increasing Cardiac Rehabilitation Participation Among Medicaid Enrollees
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
April 2014 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
February 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont
Collaborators
National Institute of General Medical Sciences (NIGMS)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
cardiac rehabilitation, contingency management
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Financial incentives
Arm Type
Experimental
Arm Description
Participants receive financial incentives for completing exercise sessions.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants receive an equal amount of clinical contact but no financial incentives for completing exercise visits.
Intervention Type
Behavioral
Intervention Name(s)
Financial incentives
Intervention Description
Patients in the experimental group will receive financial incentives for completing exercise sessions.
Primary Outcome Measure Information:
Title
Attendance at Cardiac Rehabilitation Exercise Sessions
Description
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.
Time Frame
Within 4 months of initial stress test
Secondary Outcome Measure Information:
Title
Change in Physical Health
Description
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.
Time Frame
Intake, 4 months
Title
Changes in Mental Health/Cognition
Description
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).
Time Frame
Changes in socio-cognitive measures will be measures from intake to completion of intervention (4 months)
Other Pre-specified Outcome Measures:
Title
Maintenance of Physical Health Gains Following Intervention.
Description
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).
Time Frame
4 months and 1 year.
Title
Maintenance of Mental Health/Cognition Scores Following Intervention.
Description
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).
Time Frame
4 months and 1 year.
Title
Health Care Costs
Description
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.
Time Frame
From intake to one year follow-up
Title
Costs of Attending Care
Description
Costs to the patient of attending care (transportation, child/elder care, missed wages) will be calculated from study entry to one year follow-up.
Time Frame
Intake to 1 year follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
31078475
Citation
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.
Results Reference
derived
Learn more about this trial
Increasing Cardiac Rehabilitation Participation Among Medicaid Enrollees
We'll reach out to this number within 24 hrs