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Incentives for Cardiac Rehabilitation (HeLP Trial)
Phase 2
Waitlist Available
Research Sponsored by University of Vermont
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year period starting at intake assessment.
Awards & highlights
HeLP Trial Summary
This trial will study whether using a case manager or financial incentives (or both) can increase the number of lower socioeconomic status patients who participate in cardiac rehabilitation after a heart event.
Who is the study for?
This trial is for low-income individuals or those with less than high school education in Burlington, Vermont area who've had a recent heart event like myocardial infarction or surgery. They should be on state support and plan to stay locally for the next year. It's not for those with severe non-cardiac diseases, past successful CR attendance, dementia, untreated psychiatric disorders (except nicotine dependence), advanced cancer/frailty, or certain heart conditions.Check my eligibility
What is being tested?
The study tests if case management and financial incentives improve participation in cardiac rehabilitation (CR) among lower-SES patients. Participants are randomly assigned to receive either case management, financial rewards for attending CR sessions, both interventions combined, or usual care without these additions.See study design
What are the potential side effects?
Since this trial involves non-medical interventions like case management and financial incentives rather than drugs or medical procedures, traditional side effects are not expected. However, participants may experience stress related to adherence to the program requirements.
HeLP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year period starting at intake assessment.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year period starting at intake assessment.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cardiac Rehabilitation Attendance
Cardiac Rehabilitation Completion
Secondary outcome measures
Change in body composition
Change in fitness
Changes in Executive Function (BRIEF)
+11 moreOther outcome measures
Cost-effectiveness
Maintenance of Executive Function (BRIEF) following intervention.
Maintenance of Executive Function (DD) following intervention.
+10 moreHeLP Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Incentives and Case ManagementExperimental Treatment2 Interventions
Patient receives both the Incentives and Case Management interventions.
Group II: IncentivesExperimental Treatment1 Intervention
Patient earns incentives for completing cardiac rehabilitation sessions.
Group III: Case ManagementExperimental Treatment1 Intervention
Patient is assigned a case manager while in hospital.
Group IV: Usual careActive Control1 Intervention
This control condition does not receive either intervention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Incentives
2018
Completed Phase 2
~1970
Case Management
2012
Completed Phase 2
~2890
Find a Location
Who is running the clinical trial?
University of VermontLead Sponsor
271 Previous Clinical Trials
3,743,606 Total Patients Enrolled
1 Trials studying Cardiac Rehabilitation
40 Patients Enrolled for Cardiac Rehabilitation
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,848 Previous Clinical Trials
47,818,053 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a condition like severe arthritis, past stroke, or lung disease that limits my ability to exercise.My severe heart rhythm problem is under control with a device.I do not have severe dementia or untreated major psychiatric disorders.I do not have a severe illness that would stop me from joining the clinical trial.I experience chest pain with minimal activity or while resting.I experience heart failure symptoms even when resting.I have recently had a heart attack, heart surgery, or been diagnosed with heart failure.
Research Study Groups:
This trial has the following groups:- Group 1: Incentives
- Group 2: Case Management
- Group 3: Incentives and Case Management
- Group 4: Usual care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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