Improving Participation in Cardiac Rehabilitation Among Lower-Socioeconomic Status Patients: Efficacy of Early Case Management and Financial Incentives
| Registry | NCT03759873, acronym HeLP |
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| Status | Completed |
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| Phase | Phase 2 |
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| Study type | Interventional; randomized, parallel, masking: double, treatment |
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| Enrollment | 209 (Actual) |
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| Sponsor | University of Vermont (Other); collaborators: National Heart, Lung, and Blood Institute (NHLBI) |
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| Conditions | Cardiac Rehabilitation |
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| Interventions | Incentives, Case Management (Behavioral) |
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| Dates | start 2018-12-03, primary completion 2023-05-01, completion 2024-02-28, first posted 2018-11-30, last updated 2024-10-09 |
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| Locations | 1 site in United States |
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-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. 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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Incentives | Experimental | Behavioral: Incentives | Patient earns incentives for completing cardiac rehabilitation sessions. |
| Case Management | Experimental | Behavioral: Case Management | Patient is assigned a case manager while in hospital. |
| Incentives and Case Management | Experimental | Behavioral: Incentives; Behavioral: Case Management | Patient receives both the Incentives and Case Management interventions. |
| Usual care | No intervention | | This control condition does not receive either intervention. |
- Incentives (Behavioral): Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions.
- Case Management (Behavioral): A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.
+Outcome measures
Primary outcomes
- Cardiac Rehabilitation Attendance [Within 4 months of the intake assessment]: Number of cardiac rehabilitation sessions completed out of a possible 36
- Cardiac Rehabilitation Completion [Within 4 months of the intake assessment]: Proportion of patients who complete 30+ sessions of cardiac rehabilitation
Secondary outcomes
- Change in Fitness (Peak Oxygen Uptake) [Within 4 months of the intake assessment]: Changes in fitness level (peak oxygen uptake) will be measured from intake to completion of the intervention (4 months after intake).
- Change in Fitness (Estimated Metabolic Equivalent of Task) [Within 4 months of the intake assessment]: Changes in fitness level (Metabolic Equivalent of Tasks) will be measured from intake to completion of the intervention (4 months after intake).
- Change in Body Composition [Within 4 months of the intake assessment]: Changes in waist measurement will be measured from intake to completion of the intervention (4 months after intake).
- Changes in Smoking Status [Within 4 months of the intake assessment]: Changes in smoking status will be measured from intake to completion of the intervention (4 months after intake).
- Changes in Quality of Life - Cardiac Specific [Within 4 months of the intake assessment]: Changes in perceived quality of life (MacNew) questionnaires will be measured from intake to completion of the intervention (4 months after intake). The MacNew Heart Disease Health-Related Quality of Life Questionnaire was used. Scores range from 1 to 7, with higher scores indicating better outcomes.
- Changes in Quality of Life - Non-specific [Within 4 months of the intake assessment]: Changes in perceived quality of life (EuroQoL) questionnaires will be measured from intake to completion of the intervention (4 months after intake). The Visual Analogue Scale of the EuroQol-5D-3L was used. Scores range from 0 to 100, with higher scores indicating better outcomes.
- Changes in Mental Health [Within 4 months of the intake assessment]: Changes in mental health (Adult Self-Report) questionnaires will be measured from intake to completion of the intervention (4 months after intake) using the Achenbach System of Empirically Based Assessment (ASEBA). T-scores are reported. A T-score of 50 indicates the population mean, and 10 is the standard deviation. Higher T-scores indicate worse outcomes. T-scores above 63 indicate clinically significant problems, and those between 60 and 63 fall within the borderline clinical range.
- Changes in Depressive Symptoms [Within 4 months of the intake assessment]: Changes in reported depressive symptoms "The Beck Depression Inventory (BDI)" will be measured from intake to completion of the intervention (4 months after intake). BDI results will be back transformed due to data being square root transformed. Scores range from 0 to 63, with higher scores indicating worse outcomes.
- Changes in Executive Function (Delay Discounting) [Within 4 months of the intake assessment]: Changes in Executive function (delay discounting) will be measured from intake to completion of the intervention (4 months after intake). A 5-trial adjusting delay discounting task was used to calculate k values, numerical representations of the rate of discounting. k values range from 0 to 0.5, with larger values indicating steeper discounting (more impulsivity; greater propensity to devalue delayed rewards in favor of more immediate outcomes). k values were log(10) transformed for analysis. Larger log transformed k values indicate steeper discounting.
- Changes in Executive Function (DS) [Within 4 months of the intake assessment]: Changes in Executive function (digit span) will be measured from intake to completion of the intervention (4 months after intake). The Digit Span subtest of the Wechsler Adult Intelligence Scale-IV (WAIS-IV) was used. Scores range from 1 to 19, with higher scores indicating worse outcomes.
- Changes in Executive Function (Trail) [Within 4 months of the intake assessment]: Changes in Executive function (Trail making task) will be measured from intake to completion of the intervention (4 months after intake). The Trail-Making subtest of the Delis-Kaplan Executive Function System (D-KEFS) was used. Scores range from 1 to 19, with higher scores indicating worse outcomes.
- Changes in Executive Function (BRIEF) [Within 4 months of the intake assessment]: Changes in self-reported Executive function problems (BRIEF) will be measured from intake to completion of the intervention (4 months after intake). The Global Executive Composite (GEC) of the Behavior Rating Inventory of Executive Function (BRIEF) was used. T-scores are reported. A T-score of 50 indicates the population mean, and 10 is the standard deviation. Higher T-scores indicate worse outcomes. T-scores above 65 indicate clinically significant problems.
- Changes in Executive Function (SST) [Within 4 months of the intake assessment]: Changes in Executive function (Stop Signal Task) will be measured from intake to completion of the intervention (4 months after intake).
- Health Care Contacts [One year period starting at intake assessment.]: Combined measure of number of Emergency Department (ED) visits and overnight hospitalizations.
- Health Care Costs [One year period starting at intake assessment.]: Costs associated with combined Emergency Department (ED) visits and overnight hospitalizations.
Other outcomes
- Maintenance of Fitness Following Intervention (Peak Oxygen Uptake) [From completion of intervention (4 months) to follow-up (one-year).]: Changes in fitness level (peak oxygen uptake) will be measured from intervention completion until follow-up (8 months after intervention completion).
- Maintenance of Fitness Following Intervention (Estimated Metabolic Equivalent of Task) [From completion of intervention (4 months) to follow-up (one-year).]: Changes in fitness level (Estimated Metabolic Equivalent of Task) will be measured from intervention completion until follow-up (8 months after intervention completion).
- Maintenance of Waist Circumference Following Intervention. [From completion of intervention (4 months) to follow-up (one-year).]: Changes in waist circumference will be measured from intervention completion until follow-up (8 months after intervention completion).
- Maintenance of Smoking Status Following Intervention. [From completion of intervention (4 months) to follow-up (one-year).]: Changes in smoking status will be measured from intervention completion until follow-up (8 months after intervention completion).
- Maintenance of Quality of Life (Cardiac-specific) Following Intervention. [From completion of intervention (4 months) to follow-up (one-year).]: Changes in perceived quality of life (MacNew) questionnaires will be measured from intervention completion until follow-up (8 months after intervention completion). The MacNew Heart Disease Health-Related Quality of Life Questionnaire was used. Scores range from 1 to 7, with higher scores indicating better outcomes.
- Maintenance of Quality of Life (Noncardiac-specific) Following Intervention. [From completion of intervention (4 months) to follow-up (one-year).]: Changes in perceived quality of life (EuroQoL) questionnaires will be measured from intervention completion until follow-up (8 months after intervention completion). The Visual Analogue Scale of the EuroQol-5D-3L was used. Scores range from 0 to 100, with higher scores indicating better outcomes.
- Maintenance of Mental Health Following Intervention. [From completion of intervention (4 months) to follow-up (one-year).]: Changes in mental health (Adult Self-Report) questionnaires will be measured from intervention completion until follow-up (8 months after intervention completion) using the Achenbach System of Empirically Based Assessment (ASEBA). T-scores are reported. A T-score of 50 indicates the population mean, and 10 is the standard deviation. Higher T-scores indicate worse outcomes. T-scores above 63 indicate clinically significant problems, and those between 60 and 63 fall within the borderline clinical range.
- Maintenance of Depressive Symptoms Following Intervention. [From completion of intervention (4 months) to follow-up (one-year).]: Changes in reported depressive symptoms "The Beck Depression Inventory (BDI)" will be measured from intervention completion until follow-up (8 months after intervention completion). BDI results will be back transformed due to data being square root transformed. Scores range from 0 to 63, with higher scores indicating worse outcomes.
- Maintenance of Executive Function (Delay Discounting) Following Intervention. [From completion of intervention (4 months) to follow-up (one-year).]: Changes in Executive function (delay discounting) will be measured from intervention completion until follow-up (8 months after intervention completion). A 5-trial adjusting delay discounting task will be used to calculate k values, numerical representations of the rate of discounting. k values range from 0 to 0.5, with larger values indicating steeper discounting (more impulsivity; greater propensity to devalue delayed rewards in favor of more immediate outcomes). k values were log(10) transformed for analysis. Larger log transformed k values indicate steeper discounting.
- Maintenance of Executive Function (DS) Following Intervention. [From completion of intervention (4 months) to follow-up (one-year).]: Changes in Executive function (digit span) will be measured from intervention completion until follow-up (8 months after intervention completion). The Digit Span subtest of the Wechsler Adult Intelligence Scale-IV (WAIS-IV) was used. Scores range from 1 to 19, with higher scores indicating worse outcomes.
- Maintenance of Executive Function (BRIEF) Following Intervention. [From completion of intervention (4 months) to follow-up (one-year).]: Changes in self-reported Executive function problems (BRIEF) will be measured from intervention completion until follow-up (8 months after intervention completion). The Global Executive Composite (GEC) of the Behavior Rating Inventory of Executive Function (BRIEF) was used. T-scores are reported. A T-score of 50 indicates the population mean, and 10 is the standard deviation. Higher T-scores indicate worse outcomes. T-scores above 65 indicate clinically significant problems.
- Maintenance of Executive Function (SST) Following Intervention. [From completion of intervention (4 months) to follow-up (one-year).]: Changes in Executive function (stop signal task) will be measured from intervention completion until follow-up (8 months after intervention completion).
- Maintenance of Executive Function (Trail) Following Intervention. [From completion of intervention (4 months) to follow-up (one-year).]: Changes in Executive function (trail making task) will be measured from intervention completion until follow-up (8 months after intervention completion). The Trail-Making subtest of the Delis-Kaplan Executive Function System (D-KEFS) was used. Scores range from 1 to 19, with higher scores indicating worse outcomes.
- Cost-effectiveness [One year period starting at intake assessment.]: Cost-effectiveness of the intervention will be determined. Cost-effectiveness is a single outcome (cost per per quality-adjusted life year gained) that is calculated by integrating the cost of delivering the intervention, the cost to the patient of receiving the intervention, and the benefits both in quality of life and in reductions in healthcare utilization.
+Eligibility
Sex: All, ages: 18 Years to any
Inclusion Criteria:
* A recent myocardial infarction, coronary revascularization, diagnosis of congestive heart failure (CHF) or heart valve replacement or repair
* Enrolled in a state-supported insurance plan for low income individuals or receiving other state benefits that are based on financial need (housing subsidy, food stamps, etc.), or with a less than high school education.
* Lives in and plans to remain in the greater Burlington, Vermont area (Chittenden county) for the next 12 mos.
* Copley Hospital (Morrisville, VT) transfer patient (enrolled in a state-supported insurance plan for low income individuals or receiving other state benefits that are based on financial need)
* Northwestern Medical Center (St Albans, VT) transfer patient (enrolled in a state-supported insurance plan for low income individuals or receiving other state benefits that are based on financial need)
Exclusion Criteria:
* Dementia (MMSE<20) or current untreated Axis 1 psychiatric disorder other than nicotine dependence as determined by medical history
* 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
* Previous successful attendance at cardiac rehabilitation (defined as completing 6+ sessions in the past 10 years)
+Posted results
Participant flow
| Milestone | Incentives | Case Management | Incentives and Case Management | Usual Care |
|---|
| Started | 57 | 57 | 57 | 38 |
| Completed | 53 | 51 | 52 | 36 |
| Not completed | 4 | 6 | 5 | 2 |
Outcome results
- Cardiac Rehabilitation Attendance (Primary), Least squares mean, sessions of CR: Incentives 16.9 (12.7 to 21.1); Case Management 12.0 (7.7 to 16.1); Incentives and Case Management 24.1 (19.9 to 28.4); Usual Care 10.9 (5.8 to 15.9)
- Cardiac Rehabilitation Completion (Primary), Count of participants, Participants: Incentives 22; Case Management 13; Incentives and Case Management 32; Usual Care 4
- Change in Fitness (Peak Oxygen Uptake) (Secondary), Least squares mean, milliliters per kilogram per minute: Incentives 20.9 (20.0 to 21.9); Case Management 18.3 (17.3 to 19.3); Incentives and Case Management 18.6 (17.7 to 19.5); Usual Care 21.2 (19.8 to 22.6)
- Change in Fitness (Estimated Metabolic Equivalent of Task) (Secondary), Least squares mean, milliliters per kilogram per minute: Incentives 7.4 (6.8 to 8.1); Case Management 6.5 (5.8 to 7.2); Incentives and Case Management 7.0 (6.3 to 7.7); Usual Care 6.7 (5.7 to 7.8)
- Change in Body Composition (Secondary), Least squares mean, inches: Incentives 42.1 (41.6 to 42.6); Case Management 42.7 (42.1 to 43.2); Incentives and Case Management 42.1 (41.7 to 42.6); Usual Care 42.0 (41.3 to 42.7)
- Changes in Smoking Status (Secondary), Count of participants, Participants: Incentives 8; Case Management 10; Incentives and Case Management 11; Usual Care 5
- Changes in Quality of Life - Cardiac Specific (Secondary), Least squares mean, score on a scale: Incentives 5.4 (5.3 to 5.6); Case Management 5.4 (5.2 to 5.6); Incentives and Case Management 5.2 (5.1 to 5.4); Usual Care 5.4 (5.2 to 5.7)
- Changes in Quality of Life - Non-specific (Secondary), Least squares mean, score on a scale: Incentives 66.0 (61.9 to 70.2); Case Management 66.2 (61.5 to 70.9); Incentives and Case Management 70.3 (66.2 to 74.3); Usual Care 64.0 (57.7 to 70.4)
- Changes in Mental Health (Secondary), Least squares mean, T scores: Incentives 54.16 (52.45 to 55.86); Case Management 55.58 (53.70 to 57.46); Incentives and Case Management 55.41 (53.86 to 56.96); Usual Care 52.82 (50.33 to 55.31)
- Changes in Depressive Symptoms (Secondary), Least squares mean, score on a scale: Incentives 9.0 (7.3 to 10.8); Case Management 6.6 (5.1 to 8.3); Incentives and Case Management 9.1 (7.5 to 10.9); Usual Care 6.6 (4.7 to 8.8)
- Changes in Executive Function (Delay Discounting) (Secondary), Least squares mean, log of k: Incentives -1.82 (-2.11 to -1.52); Case Management -1.94 (-2.26 to -1.61); Incentives and Case Management -2.32 (-2.58 to -2.05); Usual Care -2.52 (-2.91 to -2.13)
- Changes in Executive Function (DS) (Secondary), Least squares mean, score on a scale: Incentives 8.51 (8.13 to 8.90); Case Management 8.21 (7.77 to 8.65); Incentives and Case Management 9.16 (8.82 to 9.51); Usual Care 8.87 (8.35 to 9.39)
- Changes in Executive Function (Trail) (Secondary), Least squares mean, score on a scale: Incentives 10.19 (9.59 to 10.78); Case Management 10.19 (9.46 to 10.93); Incentives and Case Management 10.29 (9.74 to 10.85); Usual Care 11.01 (10.22 to 11.80)
- Changes in Executive Function (BRIEF) (Secondary), Least squares mean, T scores: Incentives 55.35 (53.54 to 57.15); Case Management 56.64 (54.44 to 58.84); Incentives and Case Management 55.67 (53.96 to 57.39); Usual Care 54.91 (52.43 to 57.39)
- Changes in Executive Function (SST) (Secondary), Least squares mean, seconds: Incentives 180.86 (162.62 to 199.09); Case Management 182.53 (163.40 to 201.65); Incentives and Case Management 221.77 (206.75 to 236.80); Usual Care 165.26 (141.26 to 189.26)
- Health Care Contacts (Secondary), Number, number of visits: Incentives 113; Case Management 180; Incentives and Case Management 201; Usual Care 142
- Health Care Costs (Secondary)
- Maintenance of Fitness Following Intervention (Peak Oxygen Uptake) (Other pre specified), Mean, milliliters per kilogram per minute: Incentives 20.2 +/- 5.8; Case Management 18.5 +/- 6.3; Incentives and Case Management 21.3 +/- 7.4; Usual Care 19.0 +/- 7.4
- Maintenance of Fitness Following Intervention (Estimated Metabolic Equivalent of Task) (Other pre specified), Mean, milliliters per kilogram per minute: Incentives 6.4 +/- 3.3; Case Management 6.8 +/- 3.0; Incentives and Case Management 7.4 +/- 3.5; Usual Care 6.4 +/- 2.8
- Maintenance of Waist Circumference Following Intervention. (Other pre specified), Mean, inches: Incentives 42.5 +/- 7.1; Case Management 44.2 +/- 8.8; Incentives and Case Management 42.0 +/- 7.0; Usual Care 42.2 +/- 7.4
- 11 more outcome measures not shown.
Adverse events
Time frame: 1 Year
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|
| Incentives | 3/53 (5.7%) | 15/53 (28.3%) | 39/53 (73.6%) |
| Case Management | 5/51 (9.8%) | 25/51 (49.0%) | 42/51 (82.4%) |
| Incentives and Case Management | 3/52 (5.8%) | 20/52 (38.5%) | 42/52 (80.8%) |
| Usual Care | 0/36 (0.0%) | 16/36 (44.4%) | 27/36 (75.0%) |
Serious adverse events by term
| Term | Organ system | Incentives | Case Management | Incentives and Case Management | Usual Care |
|---|
| Abdominal Pain | Gastrointestinal disorders | 0/53 | 0/51 | 2/52 | 1/36 |
| Acute Kidney Injury | Renal and urinary disorders | 1/53 | 0/51 | 0/52 | 1/36 |
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/53 | 0/51 | 0/52 | 0/36 |
| Alcohol Intoxication | Injury, poisoning and procedural complications | 1/53 | 0/51 | 0/52 | 0/36 |
| Atrial Fibrillation | Cardiac disorders | 0/53 | 0/51 | 2/52 | 1/36 |
| Back Pain | Musculoskeletal and connective tissue disorders | 0/53 | 0/51 | 1/52 | 0/36 |
| Cardiac Arrest | Cardiac disorders | 1/53 | 1/51 | 0/52 | 0/36 |
| Cardiac Disorders - Other | Cardiac disorders | 1/53 | 0/51 | 1/52 | 1/36 |
| Cardiogenic Shock | Cardiac disorders | 0/53 | 1/51 | 0/52 | 0/36 |
| Chest Pain - Cardiac | Cardiac disorders | 2/53 | 4/51 | 5/52 | 7/36 |
| Cholecystitis | Hepatobiliary disorders | 0/53 | 1/51 | 0/52 | 0/36 |
| Colorectal Cancer | Gastrointestinal disorders | 0/53 | 1/51 | 0/52 | 0/36 |
| Coronary Artery Bypass | Cardiac disorders | 0/53 | 1/51 | 0/52 | 0/36 |
| Death NOS | General disorders | 3/53 | 4/51 | 2/52 | 0/36 |
| Dehydration | Metabolism and nutrition disorders | 0/53 | 0/51 | 1/52 | 0/36 |
| Diarrhea | Gastrointestinal disorders | 0/53 | 0/51 | 1/52 | 0/36 |
| Dizziness | Nervous system disorders | 0/53 | 1/51 | 0/52 | 0/36 |
| Dysarthria | Nervous system disorders | 0/53 | 0/51 | 1/52 | 0/36 |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | 2/53 | 5/51 | 1/52 | 3/36 |
| Edema Limbs | General disorders | 1/53 | 0/51 | 0/52 | 0/36 |
| Failure to Thrive | General disorders | 0/53 | 1/51 | 0/52 | 0/36 |
| Fall | Injury, poisoning and procedural complications | 1/53 | 1/51 | 0/52 | 0/36 |
| Gastric Hemorrhage | Gastrointestinal disorders | 0/53 | 1/51 | 1/52 | 0/36 |
| Gastrointestinal Disorders - Other | Gastrointestinal disorders | 0/53 | 1/51 | 1/52 | 0/36 |
| Heart Failure | Cardiac disorders | 1/53 | 1/51 | 1/52 | 0/36 |
| Hyperglycemia | Metabolism and nutrition disorders | 0/53 | 0/51 | 1/52 | 0/36 |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | 1/53 | 0/51 | 0/52 | 0/36 |
| Infections and Infestations - Other | Infections and infestations | 0/53 | 0/51 | 1/52 | 0/36 |
| Kidney Infection | Infections and infestations | 0/53 | 1/51 | 0/52 | 0/36 |
| Malaise | General disorders | 0/53 | 0/51 | 1/52 | 0/36 |
| Mania | Psychiatric disorders | 0/53 | 0/51 | 1/52 | 0/36 |
| Myocardial Infarction | Cardiac disorders | 0/53 | 1/51 | 0/52 | 0/36 |
| Pain | General disorders | 0/53 | 0/51 | 0/52 | 1/36 |
| Pneumonia | Infections and infestations | 0/53 | 0/51 | 1/52 | 0/36 |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | 1/53 | 0/51 | 0/52 | 0/36 |
| Psychosis | Psychiatric disorders | 0/53 | 0/51 | 1/52 | 0/36 |
| Sepsis | Infections and infestations | 1/53 | 0/51 | 0/52 | 0/36 |
| Small Intestinal Obstruction | Gastrointestinal disorders | 0/53 | 0/51 | 1/52 | 2/36 |
| Stroke | Nervous system disorders | 0/53 | 0/51 | 1/52 | 2/36 |
| Suicidal Ideation | Psychiatric disorders | 1/53 | 0/51 | 0/52 | 0/36 |
| Surgical and Medical Procedures - Other | Surgical and medical procedures | 4/53 | 7/51 | 2/52 | 4/36 |
| Syncope | Nervous system disorders | 1/53 | 1/51 | 2/52 | 0/36 |
| Thromboembolic Event | Vascular disorders | 0/53 | 1/51 | 0/52 | 0/36 |
| Urinary Tract Infection | Infections and infestations | 1/53 | 0/51 | 0/52 | 0/36 |
| Vaginal Infection | Infections and infestations | 0/53 | 1/51 | 0/52 | 0/36 |
| Ventricular Tachycardia | Cardiac disorders | 0/53 | 1/51 | 0/52 | 0/36 |
| Visceral Arterial Ischemia | Vascular disorders | 0/53 | 0/51 | 1/52 | 0/36 |
| Vomiting | Gastrointestinal disorders | 0/53 | 0/51 | 1/52 | 0/36 |
| Wound Complication | Injury, poisoning and procedural complications | 0/53 | 1/51 | 0/52 | 0/36 |
Other adverse events by term
| Term | Organ system | Incentives | Case Management | Incentives and Case Management | Usual Care |
|---|
| Abdominal distension | Gastrointestinal disorders | 0/53 | 1/51 | 1/52 | 0/36 |
| Abdominal pain | Gastrointestinal disorders | 1/53 | 3/51 | 4/52 | 7/36 |
| Agitation | Psychiatric disorders | 0/53 | 1/51 | 0/52 | 0/36 |
| Allergic reaction | Immune system disorders | 1/53 | 0/51 | 0/52 | 0/36 |
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | 0/53 | 0/51 | 1/52 | 0/36 |
| Anemia | Blood and lymphatic system disorders | 1/53 | 0/51 | 0/52 | 0/36 |
| Animal bite | Injury, poisoning and procedural complications | 0/53 | 1/51 | 0/52 | 0/36 |
| Anxiety | Psychiatric disorders | 0/53 | 1/51 | 1/52 | 0/36 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 0/53 | 1/51 | 0/52 | 0/36 |
| Arthritis | Musculoskeletal and connective tissue disorders | 1/53 | 1/51 | 3/52 | 0/36 |
| Atrial fibrillation | Cardiac disorders | 0/53 | 0/51 | 0/52 | 1/36 |
| Back pain | Musculoskeletal and connective tissue disorders | 1/53 | 4/51 | 3/52 | 4/36 |
| Blood and lymphatic system disorders - Other | Blood and lymphatic system disorders | 0/53 | 1/51 | 0/52 | 0/36 |
| Bone pain | Musculoskeletal and connective tissue disorders | 3/53 | 0/51 | 0/52 | 0/36 |
| Bruising | Injury, poisoning and procedural complications | 0/53 | 2/51 | 0/52 | 0/36 |
| Cardiac disorders - Other | Cardiac disorders | 1/53 | 1/51 | 4/52 | 1/36 |
| Chest pain - cardiac | Cardiac disorders | 6/53 | 9/51 | 8/52 | 7/36 |
| Chest Pressure | Cardiac disorders | 0/53 | 0/51 | 1/52 | 0/36 |
| Chest wall pain | Musculoskeletal and connective tissue disorders | 1/53 | 0/51 | 3/52 | 0/36 |
| Cholesterol high | Investigations | 1/53 | 0/51 | 0/52 | 0/36 |
| Colorectal cancer | Gastrointestinal disorders | 0/53 | 1/51 | 0/52 | 0/36 |
| Common Cold | Infections and infestations | 1/53 | 0/51 | 0/52 | 0/36 |
| Constipation | Gastrointestinal disorders | 1/53 | 0/51 | 0/52 | 0/36 |
| COPD | Respiratory, thoracic and mediastinal disorders | 1/53 | 0/51 | 0/52 | 0/36 |
| Cough | Respiratory, thoracic and mediastinal disorders | 1/53 | 3/51 | 1/52 | 0/36 |
| COVID-19 | Infections and infestations | 3/53 | 2/51 | 3/52 | 4/36 |
| Cystitis noninfective | Renal and urinary disorders | 0/53 | 1/51 | 0/52 | 0/36 |
| Death NOS | General disorders | 0/53 | 1/51 | 0/52 | 0/36 |
| Dehydration | Metabolism and nutrition disorders | 0/53 | 0/51 | 0/52 | 1/36 |
| Dental abscess | Infections and infestations | 0/53 | 1/51 | 0/52 | 0/36 |
| Depression | Psychiatric disorders | 0/53 | 2/51 | 0/52 | 1/36 |
| Diarrhea | Gastrointestinal disorders | 0/53 | 1/51 | 1/52 | 1/36 |
| Dizziness | Nervous system disorders | 3/53 | 2/51 | 5/52 | 1/36 |
| Domestic violence assault | Injury, poisoning and procedural complications | 0/53 | 1/51 | 0/52 | 0/36 |
| Dry eye | Eye disorders | 1/53 | 0/51 | 0/52 | 0/36 |
| Dysphagia | Gastrointestinal disorders | 0/53 | 0/51 | 0/52 | 1/36 |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | 5/53 | 5/51 | 4/52 | 6/36 |
| Dysuria | Renal and urinary disorders | 0/53 | 0/51 | 0/52 | 1/36 |
| Ear pain | Ear and labyrinth disorders | 0/53 | 0/51 | 1/52 | 1/36 |
| Edema | General disorders | 0/53 | 0/51 | 0/52 | 1/36 |
| Edema face | General disorders | 1/53 | 0/51 | 0/52 | 0/36 |
| Edema limbs | General disorders | 0/53 | 3/51 | 2/52 | 0/36 |
| Endocrine disorders - Other | Endocrine disorders | 0/53 | 0/51 | 3/52 | 0/36 |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 0/53 | 2/51 | 0/52 | 0/36 |
| Eye disorders - Other | Eye disorders | 1/53 | 0/51 | 0/52 | 0/36 |
| Eye infection | Infections and infestations | 1/53 | 0/51 | 1/52 | 0/36 |
| Eye pain | Eye disorders | 0/53 | 1/51 | 1/52 | 0/36 |
| Fall | Injury, poisoning and procedural complications | 1/53 | 2/51 | 5/52 | 5/36 |
| Fatigue | General disorders | 0/53 | 2/51 | 1/52 | 0/36 |
| Fever | General disorders | 1/53 | 0/51 | 0/52 | 0/36 |
| Flatulence | Gastrointestinal disorders | 0/53 | 0/51 | 0/52 | 1/36 |
| Flu like symptoms | General disorders | 1/53 | 2/51 | 0/52 | 1/36 |
| Fracture | Injury, poisoning and procedural complications | 0/53 | 2/51 | 0/52 | 0/36 |
| Gastroesophageal reflux disease | Gastrointestinal disorders | 1/53 | 3/51 | 1/52 | 0/36 |
| Gastrointestinal disorders - Other | Gastrointestinal disorders | 1/53 | 1/51 | 1/52 | 0/36 |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | 0/53 | 0/51 | 1/52 | 0/36 |
| Gum infection | Infections and infestations | 0/53 | 0/51 | 1/52 | 0/36 |
| Headache | Nervous system disorders | 1/53 | 2/51 | 0/52 | 1/36 |
| Hematoma | Vascular disorders | 1/53 | 0/51 | 1/52 | 0/36 |
| Hematuria | Renal and urinary disorders | 1/53 | 0/51 | 1/52 | 0/36 |
79 more terms not shown.
Limitations and caveats: Study was powered for attendance rather than clinical outcomes; Study was conducted exclusively within Vermont, which may limit generalizability; Some assessment data are limited due to COVID-19 restrictions
+Locations (1)
| Facility | City | Country | Status |
|---|
| University of Vermont Medical Center | Burlington, Vermont | United States | |
+Publications
- Results publication: Gaalema DE, Khadanga S, Savage PD, Yant B, Katz BR, DeSarno M, Ades PA. Improving Cardiac Rehabilitation Adherence in Patients With Lower Socioeconomic Status: A Randomized Clinical Trial. JAMA Intern Med. 2024 Sep 1;184(9):1095-1104. doi: 10.1001/jamainternmed.2024.3338. PMID 39037811
+Study documents