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Incentives and Case Management to Improve Cardiac Care: Healthy Lifestyle Program
Phase 2 trial testing Incentives in Cardiac Rehabilitation in 209 participants. Completed in 28 February 2024.
| Lead sponsor | University of Vermont |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 209 |
| Start date | 3 December 2018 |
| Primary completion | 1 May 2023 |
| Estimated completion | 28 February 2024 |
| Sites | 1 location across United States |
University of Vermont
18 and older, any sex, with Cardiac Rehabilitation. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of cardiac rehabilitation sessions completed out of a possible 36
| Group | Value | 95% CI |
|---|---|---|
| Incentives | 16.9 | 12.7 – 21.1 |
| Case Management | 12.0 | 7.7 – 16.1 |
| Incentives and Case Management | 24.1 | 19.9 – 28.4 |
| Usual Care | 10.9 | 5.8 – 15.9 |
Proportion of patients who complete 30+ sessions of cardiac rehabilitation
| Group | Value | 95% CI |
|---|---|---|
| Incentives | 22 | |
| Case Management | 13 | |
| Incentives and Case Management | 32 | |
| Usual Care | 4 |
Changes in fitness level (peak oxygen uptake) will be measured from intake to completion of the intervention (4 months after intake).
| Group | Value | 95% CI |
|---|---|---|
| Incentives | 20.9 | 20.0 – 21.9 |
| Case Management | 18.3 | 17.3 – 19.3 |
| Incentives and Case Management | 18.6 | 17.7 – 19.5 |
| Usual Care | 21.2 | 19.8 – 22.6 |
Changes in fitness level (Metabolic Equivalent of Tasks) will be measured from intake to completion of the intervention (4 months after intake).
| Group | Value | 95% CI |
|---|---|---|
| Incentives | 7.4 | 6.8 – 8.1 |
| Case Management | 6.5 | 5.8 – 7.2 |
| Incentives and Case Management | 7.0 | 6.3 – 7.7 |
| Usual Care | 6.7 | 5.7 – 7.8 |
Changes in waist measurement will be measured from intake to completion of the intervention (4 months after intake).
| Group | Value | 95% CI |
|---|---|---|
| Incentives | 42.1 | 41.6 – 42.6 |
| Case Management | 42.7 | 42.1 – 43.2 |
| Incentives and Case Management | 42.1 | 41.7 – 42.6 |
| Usual Care | 42.0 | 41.3 – 42.7 |
Changes in smoking status will be measured from intake to completion of the intervention (4 months after intake).
| Group | Value | 95% CI |
|---|---|---|
| Incentives | 8 | |
| Case Management | 10 | |
| Incentives and Case Management | 11 | |
| Usual Care | 5 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Incentives | 5.4 | 5.3 – 5.6 |
| Case Management | 5.4 | 5.2 – 5.6 |
| Incentives and Case Management | 5.2 | 5.1 – 5.4 |
| Usual Care | 5.4 | 5.2 – 5.7 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Incentives | 66.0 | 61.9 – 70.2 |
| Case Management | 66.2 | 61.5 – 70.9 |
| Incentives and Case Management | 70.3 | 66.2 – 74.3 |
| Usual Care | 64.0 | 57.7 – 70.4 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Incentives | 54.16 | 52.45 – 55.86 |
| Case Management | 55.58 | 53.70 – 57.46 |
| Incentives and Case Management | 55.41 | 53.86 – 56.96 |
| Usual Care | 52.82 | 50.33 – 55.31 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Incentives | 9.0 | 7.3 – 10.8 |
| Case Management | 6.6 | 5.1 – 8.3 |
| Incentives and Case Management | 9.1 | 7.5 – 10.9 |
| Usual Care | 6.6 | 4.7 – 8.8 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Incentives | -1.82 | -2.11 – -1.52 |
| Case Management | -1.94 | -2.26 – -1.61 |
| Incentives and Case Management | -2.32 | -2.58 – -2.05 |
| Usual Care | -2.52 | -2.91 – -2.13 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Incentives | 8.51 | 8.13 – 8.90 |
| Case Management | 8.21 | 7.77 – 8.65 |
| Incentives and Case Management | 9.16 | 8.82 – 9.51 |
| Usual Care | 8.87 | 8.35 – 9.39 |
Time frame: 1 Year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Incentives | Case Management | Incentives and Case Manage… | Usual Care |
|---|---|---|---|---|---|
| Chest Pain - Cardiac | Cardiac disorders | — | — | — | — |
| Surgical and Medical Procedures - Other | Surgical and medical procedures | — | — | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Death NOS | General disorders | — | — | — | — |
| Abdominal Pain | Gastrointestinal disorders | — | — | — | — |
| Atrial Fibrillation | Cardiac disorders | — | — | — | — |
| Small Intestinal Obstruction | Gastrointestinal disorders | — | — | — | — |
| Stroke | Nervous system disorders | — | — | — | — |
| Syncope | Nervous system disorders | — | — | — | — |
| Acute Kidney Injury | Renal and urinary disorders | — | — | — | — |
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — |
| Alcohol Intoxication | Injury, poisoning and procedural complications | — | — | — | — |
| Back Pain | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Cardiac Arrest | Cardiac disorders | — | — | — | — |
| Cardiac Disorders - Other | Cardiac disorders | — | — | — | — |
| Cardiogenic Shock | Cardiac disorders | — | — | — | — |
| Cholecystitis | Hepatobiliary disorders | — | — | — | — |
| Colorectal Cancer | Gastrointestinal disorders | — | — | — | — |
| Coronary Artery Bypass | Cardiac disorders | — | — | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — | — | — |
| Diarrhea | Gastrointestinal disorders | — | — | — | — |
| Dizziness | Nervous system disorders | — | — | — | — |
| Dysarthria | Nervous system disorders | — | — | — | — |
| Edema Limbs | General disorders | — | — | — | — |
| Failure to Thrive | General disorders | — | — | — | — |
| Reaction | System | Incentives | Case Management | Incentives and Case Manage… | Usual Care |
|---|---|---|---|---|---|
| Chest pain - cardiac | Cardiac disorders | — | — | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — | — |
| Suicidal ideation | Psychiatric disorders | — | — | — | — |
| Surgical and medical procedures - Other | Surgical and medical procedures | — | — | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Dizziness | Nervous system disorders | — | — | — | — |
| Fall | Injury, poisoning and procedural complications | — | — | — | — |
| Skin and subcutaneous tissue disorders - Oth | Skin and subcutaneous tissue disorders | — | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Cardiac disorders - Other | Cardiac disorders | — | — | — | — |
| COVID-19 | Infections and infestations | — | — | — | — |
| Hyperglycemia | Metabolism and nutrition disorders | — | — | — | — |
| Hypertension | Vascular disorders | — | — | — | — |
| Arthritis | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Bone pain | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Chest wall pain | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Edema limbs | General disorders | — | — | — | — |
| Endocrine disorders - Other | Endocrine disorders | — | — | — | — |
| Gastroesophageal reflux disease | Gastrointestinal disorders | — | — | — | — |
| Hypoglycemia | Metabolism and nutrition disorders | — | — | — | — |
| Pain | General disorders | — | — | — | — |
| Urinary tract infection | Infections and infestations | — | — | — | — |
| Bruising | Injury, poisoning and procedural complications | — | — | — | — |
| Depression | Psychiatric disorders | — | — | — | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Fatigue | General disorders | — | — | — | — |
| Flu like symptoms | General disorders | — | — | — | — |
| Fracture | Injury, poisoning and procedural complications | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — |
| Hypotension | Vascular disorders | — | — | — | — |
| Palpitations | Cardiac disorders | — | — | — | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — | — | — | — |
| Seizure | Nervous system disorders | — | — | — | — |
| Skin ulceration | Skin and subcutaneous tissue disorders | — | — | — | — |
| Syncope | Nervous system disorders | — | — | — | — |
| Tooth infection | Infections and infestations | — | — | — | — |
| Vision decreased | Eye disorders | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — |
Most-reported serious reactions: Chest Pain - Cardiac, Surgical and Medical Procedures - Other, Dyspnea, Death NOS, Abdominal Pain, Atrial Fibrillation, Small Intestinal Obstruction, Stroke.
Data from ClinicalTrials.gov NCT03759873 adverse events section.
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.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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