A Phase 2 interventional study of Incentives and Case Management in Cardiac Rehabilitation, sponsored by University of Vermont. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-09.
Sponsored by University of Vermont · Phase 2, Interventional, and Treatment
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.
University of Vermont is the lead sponsor of 215 studies on the registry; 28 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 9 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patient earns incentives for completing cardiac rehabilitation sessions.
Behavioral: Incentives
Patient is assigned a case manager while in hospital.
Behavioral: Case Management
Patient receives both the Incentives and Case Management interventions.
Behavioral: Incentives · Behavioral: Case Management
This control condition does not receive either intervention.
Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions.
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.
Cardiac Rehabilitation Attendance
Number of cardiac rehabilitation sessions completed out of a possible 36
Time frame: Within 4 months of the intake assessment
Cardiac Rehabilitation Completion
Proportion of patients who complete 30+ sessions of cardiac rehabilitation
Time frame: Within 4 months of the intake assessment
Change in Fitness (Peak Oxygen Uptake)
Changes in fitness level (peak oxygen uptake) will be measured from intake to completion of the intervention (4 months after intake).
Time frame: Within 4 months of the intake assessment
Change in Fitness (Estimated Metabolic Equivalent of Task)
Changes in fitness level (Metabolic Equivalent of Tasks) will be measured from intake to completion of the intervention (4 months after intake).
Time frame: Within 4 months of the intake assessment
Change in Body Composition
Changes in waist measurement will be measured from intake to completion of the intervention (4 months after intake).
Time frame: Within 4 months of the intake assessment
Changes in Smoking Status
Changes in smoking status will be measured from intake to completion of the intervention (4 months after intake).
Time frame: Within 4 months of the intake assessment
Changes in Quality of Life - Cardiac Specific
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.
Time frame: Within 4 months of the intake assessment
Changes in Quality of Life - Non-specific
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.
Time frame: Within 4 months of the intake assessment
Changes in Mental Health
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.
Time frame: Within 4 months of the intake assessment
Changes in Depressive Symptoms
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.
Time frame: Within 4 months of the intake assessment
Changes in Executive Function (Delay Discounting)
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.
Time frame: Within 4 months of the intake assessment
Changes in Executive Function (DS)
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.
Time frame: Within 4 months of the intake assessment
Changes in Executive Function (Trail)
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.
Time frame: Within 4 months of the intake assessment
Changes in Executive Function (BRIEF)
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.
Time frame: Within 4 months of the intake assessment
Changes in Executive Function (SST)
Changes in Executive function (Stop Signal Task) will be measured from intake to completion of the intervention (4 months after intake).
Time frame: Within 4 months of the intake assessment
Health Care Contacts
Combined measure of number of Emergency Department (ED) visits and overnight hospitalizations.
Time frame: One year period starting at intake assessment.
Health Care Costs
Costs associated with combined Emergency Department (ED) visits and overnight hospitalizations.
Time frame: One year period starting at intake assessment.
Maintenance of Fitness Following Intervention (Peak Oxygen Uptake)
Changes in fitness level (peak oxygen uptake) will be measured from intervention completion until follow-up (8 months after intervention completion).
Time frame: From completion of intervention (4 months) to follow-up (one-year).
Maintenance of Fitness Following Intervention (Estimated Metabolic Equivalent of Task)
Changes in fitness level (Estimated Metabolic Equivalent of Task) will be measured from intervention completion until follow-up (8 months after intervention completion).
Time frame: From completion of intervention (4 months) to follow-up (one-year).
Maintenance of Waist Circumference Following Intervention.
Changes in waist circumference will be measured from intervention completion until follow-up (8 months after intervention completion).
Time frame: From completion of intervention (4 months) to follow-up (one-year).
Maintenance of Smoking Status Following Intervention.
Changes in smoking status will be measured from intervention completion until follow-up (8 months after intervention completion).
Time frame: From completion of intervention (4 months) to follow-up (one-year).
Maintenance of Quality of Life (Cardiac-specific) Following Intervention.
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.
Time frame: From completion of intervention (4 months) to follow-up (one-year).
Maintenance of Quality of Life (Noncardiac-specific) Following Intervention.
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.
Time frame: From completion of intervention (4 months) to follow-up (one-year).
Maintenance of Mental Health Following Intervention.
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.
Time frame: From completion of intervention (4 months) to follow-up (one-year).
Maintenance of Depressive Symptoms Following Intervention.
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.
Time frame: From completion of intervention (4 months) to follow-up (one-year).
Maintenance of Executive Function (Delay Discounting) Following Intervention.
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.
Time frame: From completion of intervention (4 months) to follow-up (one-year).
Maintenance of Executive Function (DS) Following Intervention.
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.
Time frame: From completion of intervention (4 months) to follow-up (one-year).
Maintenance of Executive Function (BRIEF) Following Intervention.
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.
Time frame: From completion of intervention (4 months) to follow-up (one-year).
Maintenance of Executive Function (SST) Following Intervention.
Changes in Executive function (stop signal task) will be measured from intervention completion until follow-up (8 months after intervention completion).
Time frame: From completion of intervention (4 months) to follow-up (one-year).
Maintenance of Executive Function (Trail) Following Intervention.
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.
Time frame: From completion of intervention (4 months) to follow-up (one-year).
Cost-effectiveness
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.
Time frame: One year period starting at intake assessment.
| 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 |
| Withdrew: Not appropriate for cardiac rehab | 4 | 4 | 4 | 2 |
| Withdrew: Moved outside eligible area | 0 | 2 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 | 0 |
Number of cardiac rehabilitation sessions completed out of a possible 36
| sessions of CR | Incentives | Case Management | Incentives and Case Management | Usual Care |
|---|---|---|---|---|
| Cardiac Rehabilitation Attendance | 16.9 (12.7 to 21.1) | 12.0 (7.7 to 16.1) | 24.1 (19.9 to 28.4) | 10.9 (5.8 to 15.9) |
Proportion of patients who complete 30+ sessions of cardiac rehabilitation
| Participants | Incentives | Case Management | Incentives and Case Management | Usual Care |
|---|---|---|---|---|
| Cardiac Rehabilitation Completion | 22 | 13 | 32 | 4 |
Changes in fitness level (peak oxygen uptake) will be measured from intake to completion of the intervention (4 months after intake).
| milliliters per kilogram per minute | Incentives | Case Management | Incentives and Case Management | Usual Care |
|---|---|---|---|---|
| Change in Fitness (Peak Oxygen Uptake) | 20.9 (20.0 to 21.9) | 18.3 (17.3 to 19.3) | 18.6 (17.7 to 19.5) | 21.2 (19.8 to 22.6) |
Changes in fitness level (Metabolic Equivalent of Tasks) will be measured from intake to completion of the intervention (4 months after intake).
| milliliters per kilogram per minute | Incentives | Case Management | Incentives and Case Management | Usual Care |
|---|---|---|---|---|
| Change in Fitness (Estimated Metabolic Equivalent of Task) | 7.4 (6.8 to 8.1) | 6.5 (5.8 to 7.2) | 7.0 (6.3 to 7.7) | 6.7 (5.7 to 7.8) |
Changes in waist measurement will be measured from intake to completion of the intervention (4 months after intake).
| inches | Incentives | Case Management | Incentives and Case Management | Usual Care |
|---|---|---|---|---|
| Change in Body Composition | 42.1 (41.6 to 42.6) | 42.7 (42.1 to 43.2) | 42.1 (41.7 to 42.6) | 42.0 (41.3 to 42.7) |
Changes in smoking status will be measured from intake to completion of the intervention (4 months after intake).
| Participants | Incentives | Case Management | Incentives and Case Management | Usual Care |
|---|---|---|---|---|
| Changes in Smoking Status | 8 | 10 | 11 | 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.
| score on a scale | Incentives | Case Management | Incentives and Case Management | Usual Care |
|---|---|---|---|---|
| Changes in Quality of Life - Cardiac Specific | 5.4 (5.3 to 5.6) | 5.4 (5.2 to 5.6) | 5.2 (5.1 to 5.4) | 5.4 (5.2 to 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.
| score on a scale | Incentives | Case Management | Incentives and Case Management | Usual Care |
|---|---|---|---|---|
| Changes in Quality of Life - Non-specific | 66.0 (61.9 to 70.2) | 66.2 (61.5 to 70.9) | 70.3 (66.2 to 74.3) | 64.0 (57.7 to 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.
| T scores | Incentives | Case Management | Incentives and Case Management | Usual Care |
|---|---|---|---|---|
| Changes in Mental Health | 54.16 (52.45 to 55.86) | 55.58 (53.70 to 57.46) | 55.41 (53.86 to 56.96) | 52.82 (50.33 to 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.
| score on a scale | Incentives | Case Management | Incentives and Case Management | Usual Care |
|---|---|---|---|---|
| Changes in Depressive Symptoms | 9.0 (7.3 to 10.8) | 6.6 (5.1 to 8.3) | 9.1 (7.5 to 10.9) | 6.6 (4.7 to 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.
| log of k | Incentives | Case Management | Incentives and Case Management | Usual Care |
|---|---|---|---|---|
| Changes in Executive Function (Delay Discounting) | -1.82 (-2.11 to -1.52) | -1.94 (-2.26 to -1.61) | -2.32 (-2.58 to -2.05) | -2.52 (-2.91 to -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.
| score on a scale | Incentives | Case Management | Incentives and Case Management | Usual Care |
|---|---|---|---|---|
| Changes in Executive Function (DS) | 8.51 (8.13 to 8.90) | 8.21 (7.77 to 8.65) | 9.16 (8.82 to 9.51) | 8.87 (8.35 to 9.39) |
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.
| score on a scale | Incentives | Case Management | Incentives and Case Management | Usual Care |
|---|---|---|---|---|
| Changes in Executive Function (Trail) | 10.19 (9.59 to 10.78) | 10.19 (9.46 to 10.93) | 10.29 (9.74 to 10.85) | 11.01 (10.22 to 11.80) |
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.
| T scores | Incentives | Case Management | Incentives and Case Management | Usual Care |
|---|---|---|---|---|
| Changes in Executive Function (BRIEF) | 55.35 (53.54 to 57.15) | 56.64 (54.44 to 58.84) | 55.67 (53.96 to 57.39) | 54.91 (52.43 to 57.39) |
Changes in Executive function (Stop Signal Task) will be measured from intake to completion of the intervention (4 months after intake).
| seconds | Incentives | Case Management | Incentives and Case Management | Usual Care |
|---|---|---|---|---|
| Changes in Executive Function (SST) | 180.86 (162.62 to 199.09) | 182.53 (163.40 to 201.65) | 221.77 (206.75 to 236.80) | 165.26 (141.26 to 189.26) |
Combined measure of number of Emergency Department (ED) visits and overnight hospitalizations.
| number of visits | Incentives | Case Management | Incentives and Case Management | Usual Care |
|---|---|---|---|---|
| Health Care Contacts | 113 | 180 | 201 | 142 |
Costs associated with combined Emergency Department (ED) visits and overnight hospitalizations.
Results for this outcome have not been posted.
Changes in fitness level (peak oxygen uptake) will be measured from intervention completion until follow-up (8 months after intervention completion).
| milliliters per kilogram per minute | Incentives | Case Management | Incentives and Case Management | Usual Care |
|---|---|---|---|---|
| Maintenance of Fitness Following Intervention (Peak Oxygen Uptake) | 20.2 ± 5.8 | 18.5 ± 6.3 | 21.3 ± 7.4 | 19.0 ± 7.4 |
Changes in fitness level (Estimated Metabolic Equivalent of Task) will be measured from intervention completion until follow-up (8 months after intervention completion).
| milliliters per kilogram per minute | Incentives | Case Management | Incentives and Case Management | Usual Care |
|---|---|---|---|---|
| Maintenance of Fitness Following Intervention (Estimated Metabolic Equivalent of Task) | 6.4 ± 3.3 | 6.8 ± 3.0 | 7.4 ± 3.5 | 6.4 ± 2.8 |
Changes in waist circumference will be measured from intervention completion until follow-up (8 months after intervention completion).
| inches | Incentives | Case Management | Incentives and Case Management | Usual Care |
|---|---|---|---|---|
| Maintenance of Waist Circumference Following Intervention. | 42.5 ± 7.1 | 44.2 ± 8.8 | 42.0 ± 7.0 | 42.2 ± 7.4 |
Changes in smoking status will be measured from intervention completion until follow-up (8 months after intervention completion).
| Participants | Incentives | Case Management | Incentives and Case Management | Usual Care |
|---|---|---|---|---|
| Maintenance of Smoking Status Following Intervention. | 7 | 9 | 12 | 3 |
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
Changes in Executive function (stop signal task) will be measured from intervention completion until follow-up (8 months after intervention completion).
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
Collected over 1 Year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Incentives | 3/53 (5.7%) | 15/53 (28.3%) | 39/53 (73.6%) |
| Case Management | 5/51 (9.8%) | 25/51 (49%) | 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%) | 16/36 (44.4%) | 27/36 (75%) |
| Event | Incentives | Case Management | Incentives and Case Management | Usual Care |
|---|---|---|---|---|
| Chest Pain - CardiacCardiac disorders | 2/53 | 4/51 | 5/52 | 7/36 |
| Surgical and Medical Procedures - OtherSurgical and medical procedures | 4/53 | 7/51 | 2/52 | 4/36 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 2/53 | 5/51 | 1/52 | 3/36 |
| Death NOSGeneral disorders | 3/53 | 4/51 | 2/52 | 0/36 |
| Small Intestinal ObstructionGastrointestinal disorders | 0/53 | 0/51 | 1/52 | 2/36 |
| StrokeNervous system disorders | 0/53 | 0/51 | 1/52 | 2/36 |
| Abdominal PainGastrointestinal disorders | 0/53 | 0/51 | 2/52 | 1/36 |
| Atrial FibrillationCardiac disorders | 0/53 | 0/51 | 2/52 | 1/36 |
| SyncopeNervous system disorders | 1/53 | 1/51 | 2/52 | 0/36 |
| Acute Kidney InjuryRenal and urinary disorders | 1/53 | 0/51 | 0/52 | 1/36 |
| Event | Incentives | Case Management | Incentives and Case Management | Usual Care |
|---|---|---|---|---|
| Abdominal painGastrointestinal disorders | 1/53 | 3/51 | 4/52 | 7/36 |
| Chest pain - cardiacCardiac disorders | 6/53 | 9/51 | 8/52 | 7/36 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 5/53 | 5/51 | 4/52 | 6/36 |
| Suicidal ideationPsychiatric disorders | 4/53 | 7/51 | 4/52 | 6/36 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 3/53 | 1/51 | 8/52 | 2/36 |
| FallInjury, poisoning and procedural complications | 1/53 | 2/51 | 5/52 | 5/36 |
| Surgical and medical procedures - OtherSurgical and medical procedures | 5/53 | 3/51 | 7/52 | 4/36 |
| Back painMusculoskeletal and connective tissue disorders | 1/53 | 4/51 | 3/52 | 4/36 |
| COVID-19Infections and infestations | 3/53 | 2/51 | 3/52 | 4/36 |
| HyperglycemiaMetabolism and nutrition disorders | 0/53 | 0/51 | 0/52 | 4/36 |
| Age, Categorical(Participants) | Incentives | Case Management | Incentives and Case Management | Usual Care | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 39 | 39 | 42 | 27 | 147 |
| >=65 years | 14 | 12 | 10 | 9 | 45 |
| Age, Continuous(years) | Incentives | Case Management | Incentives and Case Management | Usual Care | Total |
|---|---|---|---|---|---|
| Mean | 57.6 ± 11.2 | 57.9 ± 12.7 | 57.9 ± 10.9 | 57.1 ± 10.5 | 57.7 ± 11.3 |
| Sex: Female, Male(Participants) | Incentives | Case Management | Incentives and Case Management | Usual Care | Total |
|---|---|---|---|---|---|
| Female | 12 | 21 | 20 | 14 | 67 |
| Male | 41 | 30 | 32 | 22 | 125 |
| Race/Ethnicity, Customized(participants) | Incentives | Case Management | Incentives and Case Management | Usual Care | Total |
|---|---|---|---|---|---|
| Hispanic White | 0 | 3 | 0 | 0 | 3 |
| Hispanic Other/Multiracial | 1 | 0 | 0 | 0 | 1 |
| Black or African American | 3 | 4 | 1 | 1 | 9 |
| Asian | 1 | 0 | 0 | 2 | 3 |
| American Indian | 2 | 1 | 1 | 1 | 5 |
| Other/Multiracial | 2 | 2 | 2 | 3 | 9 |
| Non-Hispanic White | 44 | 41 | 48 | 29 | 162 |
| Region of Enrollment(participants) | Incentives | Case Management | Incentives and Case Management | Usual Care | Total |
|---|---|---|---|---|---|
| United States | 53 | 51 | 52 | 36 | 192 |
| Primary Diagnosis(Participants) | Incentives | Case Management | Incentives and Case Management | Usual Care | Total |
|---|---|---|---|---|---|
| Percutaneous Intervention | 27 | 27 | 31 | 23 | 108 |
| Coronary Artery Bypass Graft | 12 | 7 | 6 | 4 | 29 |
| Valve Replacement/Repair | 7 | 8 | 5 | 2 | 22 |
| Chronic Systolic Heart Failure | 6 | 6 | 4 | 5 | 21 |
| Myocardial Infarction | 1 | 1 | 5 | 2 | 9 |
| Stable Angina | 0 | 2 | 1 | 0 | 3 |
| Currently Smoking(Participants) | Incentives | Case Management | Incentives and Case Management | Usual Care | Total |
|---|---|---|---|---|---|
| Count of participants | 23 | 21 | 23 | 18 | 85 |
| Patient Health Questionnaire-2(Participants) | Incentives | Case Management | Incentives and Case Management | Usual Care | Total |
|---|---|---|---|---|---|
| Screen Negative (0-2) | 39 | 41 | 40 | 25 | 145 |
| Screen Positive (0-2) | 13 | 10 | 11 | 11 | 45 |
| Data Missing | 1 | 0 | 1 | 0 | 2 |
9 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
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University of Vermont