Coronary Artery Disease
Conditions
Keywords
cardiac rehabilitation, contingency management
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.
Interventions
Patients in the experimental group will receive financial incentives for completing exercise sessions.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Attendance at Cardiac Rehabilitation Exercise Sessions | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Physical Health | 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. |
| Changes in Mental Health/Cognition | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Maintenance of Physical Health Gains Following Intervention. | 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). |
| Costs of Attending Care | 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. |
| Maintenance of Mental Health/Cognition Scores Following Intervention. | 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). |
| Health Care Costs | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Financial Incentives Participants receive financial incentives for completing exercise sessions.
Financial incentives: Patients in the experimental group will receive financial incentives for completing exercise sessions. | 65 |
| Control Participants receive an equal amount of clinical contact but no financial incentives for completing exercise visits. | 65 |
| Total | 130 |
Baseline characteristics
| Characteristic | Control | Total | Financial Incentives |
|---|---|---|---|
| Age, Continuous | 55.8 years STANDARD_DEVIATION 9.2 | 57.1 years STANDARD_DEVIATION 10.2 | 58.5 years STANDARD_DEVIATION 11 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 61 Participants | 123 Participants | 62 Participants |
| Region of Enrollment United States | 65 participants | 130 participants | 65 participants |
| Sex: Female, Male Female | 21 Participants | 49 Participants | 28 Participants |
| Sex: Female, Male Male | 44 Participants | 81 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 65 | 2 / 65 |
| other Total, other adverse events | 25 / 65 | 30 / 65 |
| serious Total, serious adverse events | 26 / 65 | 27 / 65 |
Outcome results
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.
Time frame: Within 4 months of initial stress test
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Financial Incentives | Attendance at Cardiac Rehabilitation Exercise Sessions | 36 Participants |
| Control | Attendance at Cardiac Rehabilitation Exercise Sessions | 19 Participants |
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.
Time frame: Intake, 4 months
Population: Despite having 65 subjects in each of the two groups (financial incentives and control), only 55 and 57 subjects were analyzed respectively. Not every subject completed the initial intake (lost contact with 10 and 8 subjects, respectively).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Financial Incentives | Change in Physical Health | % change BMI | 0.53 percentage of change |
| Financial Incentives | Change in Physical Health | % change VO2 | 6.33 percentage of change |
| Financial Incentives | Change in Physical Health | % change Waist | -1.12 percentage of change |
| Financial Incentives | Change in Physical Health | % change cardiac-specific quality of life (MacNew) | 6.63 percentage of change |
| Control | Change in Physical Health | % change cardiac-specific quality of life (MacNew) | 10.73 percentage of change |
| Control | Change in Physical Health | % change BMI | 1.87 percentage of change |
| Control | Change in Physical Health | % change Waist | -0.23 percentage of change |
| Control | Change in Physical Health | % change VO2 | 12.54 percentage of change |
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).
Time frame: Changes in socio-cognitive measures will be measures from intake to completion of intervention (4 months)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Financial Incentives | Changes in Mental Health/Cognition | % change ASEABA | -2.03 percentage of change |
| Financial Incentives | Changes in Mental Health/Cognition | % change SSRT | 3.03 percentage of change |
| Financial Incentives | Changes in Mental Health/Cognition | % change BRIEF - A | -6.23 percentage of change |
| Control | Changes in Mental Health/Cognition | % change ASEABA | 1.03 percentage of change |
| Control | Changes in Mental Health/Cognition | % change SSRT | 16.10 percentage of change |
| Control | Changes in Mental Health/Cognition | % change BRIEF - A | 0.97 percentage of change |
Costs of Attending Care
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
Health Care Costs
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
Maintenance of Mental Health/Cognition Scores Following Intervention.
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.
Maintenance of Physical Health Gains Following Intervention.
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.