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| ID | Type | Description | Link |
|---|---|---|---|
| P20GM103644 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Financial incentives | Experimental | Participants receive financial incentives for completing exercise sessions. |
|
| Control | No Intervention | Participants receive an equal amount of clinical contact but no financial incentives for completing exercise visits. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Financial incentives | Behavioral | Patients in the experimental group will receive financial incentives for completing exercise sessions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 4 months of initial stress test |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 4 months and 1 year. |
Inclusion Criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Vermont | Burlington | Vermont | 05401 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31078475 | Derived | Gaalema DE, Elliott RJ, Savage PD, Rengo JL, Cutler AY, Pericot-Valverde I, Priest JS, Shepard DS, Higgins ST, Ades PA. Financial Incentives to Increase Cardiac Rehabilitation Participation Among Low-Socioeconomic Status Patients: A Randomized Clinical Trial. JACC Heart Fail. 2019 Jul;7(7):537-546. doi: 10.1016/j.jchf.2018.12.008. Epub 2019 May 8. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Control | Participants receive an equal amount of clinical contact but no financial incentives for completing exercise visits. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | Within 4 months of initial stress test |
|
1 year
Emergency Department (ED) visits and hospitalizations were pulled from the medical record
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 39% fewer hospital contacts in the incentive condition (p=0.079) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalizations | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Emergency Department Visit | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
Racially homogenous patient population; Baseline assessments were conducted on site; Clinical staff could not be fully blinded; Hospitalizations outside University of Vermont Medical Center may have been missed; Small sample size.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Diann Gaalema, Ph.D., PI | The University of Vermont | 802-656-9874 | Diann.Gaalema@med.uvm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 27, 2011 | Feb 26, 2019 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 24, 2015 | Feb 26, 2019 | ICF_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 27, 2011 | Apr 26, 2019 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Intake, 4 months |
| 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). | Changes in socio-cognitive measures will be measures from intake to completion of intervention (4 months) |
| 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). | 4 months and 1 year. |
| 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. | From intake to one year follow-up |
| 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. | Intake to 1 year follow-up |
Participants receive an equal amount of clinical contact but no financial incentives for completing exercise visits. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | 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. | 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). | Posted | Mean | Full Range | percentage of change | Intake, 4 months |
|
|
|
| Secondary | 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). | Posted | Mean | Full Range | percentage of change | Changes in socio-cognitive measures will be measures from intake to completion of intervention (4 months) |
|
|
|
| Other Pre-specified | 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). | Not Posted | 4 months and 1 year. | Participants |
| Other Pre-specified | 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). | Not Posted | 4 months and 1 year. | Participants |
| Other Pre-specified | 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. | Not Posted | From intake to one year follow-up | Participants |
| Other Pre-specified | 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. | Not Posted | Intake to 1 year follow-up | Participants |
| 1 |
| 65 |
| 26 |
| 65 |
| 25 |
| 65 |
| EG001 | Control | Participants receive an equal amount of clinical contact but no financial incentives for completing exercise visits. | 2 | 65 | 27 | 65 | 30 | 65 |
| Hospitalizations | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Hospitalizations | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
|
| Hospitalizations | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
|
| Hospitalizations | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
| Hospitalizations | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Hospitalizations | Eye disorders | MedDRA (19.0) | Systematic Assessment |
|
| Hospitalizations | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
|
| Hospitalizations | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Hospitalizations | Endocrine disorders | MedDRA (19.0) | Systematic Assessment |
|
| Hospitalizations | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Hospitalizations | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Hospitalizations | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Emergency Department Visit | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Emergency Department Visit | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Emergency Department Visit | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Emergency Department Visit | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
|
| Emergency Department Visit | Eye disorders | MedDRA (19.0) | Systematic Assessment |
|
| Emergency Department Visit | Reproductive system and breast disorders | MedDRA (19.0) | Systematic Assessment |
|
| Emergency Department Visit | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
| Emergency Department Visit | Endocrine disorders | MedDRA (19.0) | Systematic Assessment |
|
| Emergency Department Visit | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Emergency Department Visit | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Emergency Department Visit | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Emergency Department Visit | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Emergency Department Visit | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
|
| Emergency Department Visit | Surgical and medical procedures | MedDRA (19.0) | Systematic Assessment |
|
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| % change Waist |
|
| % change cardiac-specific quality of life (MacNew) |
|
| % change BRIEF - A |
|