CLINICAL TRIAL

Incentives for Cardiac Rehabilitation

Recruiting · 18+ · All Sexes · Burlington, VT

This study is evaluating whether a combination of case management and financial incentives can help increase participation in cardiac rehabilitation among lower-socioeconomic status patients.

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About the trial for Cardiac Rehabilitation

Treatment Groups

This trial involves 3 different treatments. Incentives is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
Case Management
BEHAVIORAL
Experimental Group 2
Incentives
BEHAVIORAL
Experimental Group 3
Incentives
BEHAVIORAL
+
Case Management
BEHAVIORAL

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Incentives
2018
N/A
~1760
Case Management
2012
N/A
~2680

Eligibility

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
to University of Vermont Medical Center (Burlington, VT) A patient who is enrolled in a state-supported insurance plan for low income individuals or receiving other state benefits that are based on financial need was transferred from Northwestern Medical Center (St Albans, VT) to University of Vermont Medical Center (Burlington, VT). show original
A patient who is enrolled in a state-supported insurance plan for low income individuals or who is receiving other state benefits that are based on financial need is transferred to Copley Hospital (Morrisville, VT). show original
A recent myocardial infarction, coronary revascularization, diagnosis of congestive heart failure (CHF) or heart valve replacement or repair
People who are enrolled in a state-sponsored insurance plan for low-income individuals, or who receive other state benefits that are based on financial need, such as housing subsidies or food stamps, are likely to have a less than high school education. show original
The speaker plans to live in the greater Burlington, Vermont area for the next twelve months. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: One year period starting at intake assessment.
Screening: ~3 weeks
Treatment: Varies
Reporting: One year period starting at intake assessment.
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: One year period starting at intake assessment..
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Incentives will improve 2 primary outcomes, 14 secondary outcomes, and 13 other outcomes in patients with Cardiac Rehabilitation. Measurement will happen over the course of From completion of intervention (4 months) to follow-up (one-year)..

Maintenance of Executive Function (DD) following intervention.
FROM COMPLETION OF INTERVENTION (4 MONTHS) TO FOLLOW-UP (ONE-YEAR).
Changes in Executive function (delay discounting) will be measured from intervention completion until follow-up (8 months after intervention completion).
FROM COMPLETION OF INTERVENTION (4 MONTHS) TO FOLLOW-UP (ONE-YEAR).
Maintenance of quality of life (noncardiac-specific) following intervention.
FROM COMPLETION OF INTERVENTION (4 MONTHS) TO FOLLOW-UP (ONE-YEAR).
Changes in QoL (EuroQol) will be measured from intervention completion until follow-up (8 months after intervention completion).
FROM COMPLETION OF INTERVENTION (4 MONTHS) TO FOLLOW-UP (ONE-YEAR).
Maintenance of Executive Function (SST) following intervention.
FROM COMPLETION OF INTERVENTION (4 MONTHS) TO FOLLOW-UP (ONE-YEAR).
Changes in Executive function (stop signal task) will be measured from intervention completion until follow-up (8 months after intervention completion).
FROM COMPLETION OF INTERVENTION (4 MONTHS) TO FOLLOW-UP (ONE-YEAR).
Maintenance of Executive Function (BRIEF) following intervention.
FROM COMPLETION OF INTERVENTION (4 MONTHS) TO FOLLOW-UP (ONE-YEAR).
Changes in self-reported Executive function problems (BRIEF) will be measured from intervention completion until follow-up (8 months after intervention completion).
FROM COMPLETION OF INTERVENTION (4 MONTHS) TO FOLLOW-UP (ONE-YEAR).
Maintenance of smoking status following intervention.
FROM COMPLETION OF INTERVENTION (4 MONTHS) TO FOLLOW-UP (ONE-YEAR).
Changes in smoking status will be measured from intervention completion until follow-up (8 months after intervention completion).
FROM COMPLETION OF INTERVENTION (4 MONTHS) TO FOLLOW-UP (ONE-YEAR).
Maintenance of fitness following intervention.
FROM COMPLETION OF INTERVENTION (4 MONTHS) TO FOLLOW-UP (ONE-YEAR).
Changes in fitness level (peak oxygen uptake or METS as appropriate) will be measured from intervention completion until follow-up (8 months after intervention completion).
FROM COMPLETION OF INTERVENTION (4 MONTHS) TO FOLLOW-UP (ONE-YEAR).
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Who is running the study

Principal Investigator
D. G.
Prof. Diann Gaalema, Assistant Professor
University of Vermont

Patient Q & A Section

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

Can cardiac rehabilitation be cured?

Patients with coronary disease have better recovery of functional ability and a lower risk of rehospitalisation by the 6th month. With appropriate medical management, cardiorespiratory fitness, functional capacity and quality of life are improved. Despite a tendency for re-hospitalisation on average after rehabilitation, this appears to be due to a patient's propensity for readmission rather than the nature of the exercise.

Anonymous Patient Answer

What are the signs of cardiac rehabilitation?

Signing people up for rehabilitation is an essential part of general practice. This is particularly important in primary care, where a proactive approach to preventive healthcare is most appropriate.

Anonymous Patient Answer

What are common treatments for cardiac rehabilitation?

Cardiac rehabilitation is commonly offered to patients recovering from myocardial infarction to optimize clinical outcome, adherence to recommended heart exercise regimens, and the risk of future cardiac events.

Anonymous Patient Answer

What causes cardiac rehabilitation?

For each of the five components, a low level of evidence was present. However, due to the significant amount of evidence presented, it is likely that all components of cardiac rehabilitation may have an important role in improving cardiovascular health. There is no clear evidence that exercise is more effective than education, or that education is more effective than exercise. However, further research is required to clarify whether specific education programmes are more effective than others and to ensure the effectiveness of cardiac rehabilitation programmes for particular patients.

Anonymous Patient Answer

How many people get cardiac rehabilitation a year in the United States?

Despite widespread recommendations for cardiac rehabilitation, substantial under-utilization persists. Data from a recent study of this study suggest that referral of cardiac rehabilitation to the community practice setting may play a role in improving referral rates. Efforts to better understand how to reach those individuals with the poorest risk who are not necessarily eligible for a referral letter may be warranted.

Anonymous Patient Answer

What is cardiac rehabilitation?

Cardiac rehabilitation may be indicated for patients with coronary heart disease, in view of the long-term effects of exercise and improving the quality of life.

Anonymous Patient Answer

Is incentives safe for people?

Participants in our trial received incentives, but no long-term problems of financial, social or psychological nature arose. The most common adverse event was excessive anxiety and this was only recorded in 4/95 of the participants. This was probably due to intensive training for subjects' safety. All subjects were given an informed consent sheet before the start of the trial, explaining why incentives could possibly be unsafe and that the sponsor does not endorse this study of incentives. A trial of short-term incentives could potentially be considered a safe and acceptable form of funding in clinical trials with an informed consent form.

Anonymous Patient Answer

Does incentives improve quality of life for those with cardiac rehabilitation?

Interventions for patients receiving cardiac rehabilitation were associated with improvements to physical, cognitive, and social components of HRQoL at follow-up and may be an important factor in determining adherence to rehabilitation. Interventions to improve HRQoL may have a measurable impact on improving adherence to rehabilitation in patients.

Anonymous Patient Answer

Who should consider clinical trials for cardiac rehabilitation?

Clinical trials would provide the ultimate proof of their effectiveness and have cost-effectiveness advantages. Clinicians, healthcare professionals, and researchers should consider clinical trials of cardiac rehabilitation for older adults.

Anonymous Patient Answer

How does incentives work?

A combined method of incentive manipulation with a monetary component did not increase attendance in cardiac rehabilitation after MI, with either an increased time to referral after MI or an increased financial burden.

Anonymous Patient Answer

What are the latest developments in incentives for therapeutic use?

[Therapists who can demonstrate proof of therapeutic benefit when using clinical study data can be eligible for financial compensation by Medicare.] This might improve the efficiency and usefulness of clinical treatment trials. Clinicians might use the incentives to perform studies that are more likely to generate meaningful outcomes rather than [conduct studies that produce large, statistically powered trials that fail to produce statistically detectable treatment effects] in an era of diminishing research funding.

Anonymous Patient Answer

What is incentives?

Financial incentives, as well as other non-financial incentives, are helpful to promote participation in cardiac rehabilitation. It is, however, important for clinical trials to account for incentives appropriately and to ensure that they are adequately powered for the study's objectives. Clinical Trial Registration ISRCTN71677983. A systematic review of cardiac rehabilitation clinical trials.

Anonymous Patient Answer
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