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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
A recent myocardial infarction, coronary revascularization, diagnosis of congestive heart failure (CHF) or heart valve replacement or repair
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 Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have recently had a heart attack, heart surgery, or been diagnosed with heart failure.

HeLP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year period starting at intake assessment.
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year period starting at intake assessment. for reporting.

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 more
Other outcome measures
Cost-effectiveness
Maintenance of Executive Function (BRIEF) following intervention.
Maintenance of Executive Function (DD) following intervention.
+10 more

HeLP 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
N/A
~1760
Case Management
2012
N/A
~2680

Find a Location

Who is running the clinical trial?

University of VermontLead Sponsor
265 Previous Clinical Trials
3,743,282 Total Patients Enrolled
1 Trials studying Cardiac Rehabilitation
40 Patients Enrolled for Cardiac Rehabilitation
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,810 Previous Clinical Trials
47,290,437 Total Patients Enrolled

Media Library

Case Management Clinical Trial Eligibility Overview. Trial Name: NCT03759873 — Phase 2
Cardiac Rehabilitation Research Study Groups: Incentives and Case Management, Usual care, Incentives, Case Management
Cardiac Rehabilitation Clinical Trial 2023: Case Management Highlights & Side Effects. Trial Name: NCT03759873 — Phase 2
Case Management 2023 Treatment Timeline for Medical Study. Trial Name: NCT03759873 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being selected for inclusion in this experiment?

"Affirmative, according to clinicaltrials.gov this research is still enrolling participants. It was first published on December 3rd 2018 and the most recent update occurred on September 7th 2022. 200 volunteers are needed from a single medical facility for inclusion in the study."

Answered by AI

Has Case Management been granted clearance by the FDA?

"As this is a Phase 2 trial, our Power team has assessed the safety of Case Management to be a 2 due to limited efficacy evidence."

Answered by AI

Is there an ongoing recruitment process for this research project?

"This study is open to participants, with the original listing being posted on December 3rd 2018 and updated most recently in September 7th 2022. The information can be found on clinicaltrials.gov."

Answered by AI

What objectives is this trial striving to accomplish?

"The objective of this evaluation, which is due to be completed over a 4 month period from the initial assessment, is for participants to complete their Cardiac Rehabilitation program. Assessed secondary outcomes include alterations in perceived quality of life (EuroQoL) questionnaires, mental health via Adult Self-Report assessments and reported depressive symptoms recorded with the Beck Depression Inventory (BDI)."

Answered by AI
~33 spots leftby Mar 2025