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Mobile Case Management for Heart Rehabilitation (iCARE Trial)

N/A

Recruiting

Led By Thomas P Olson, Ph.D., M.S.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients who have a history of one of the following; acute myocardial infarction/acute coronary syndrome, stable angina pectoris, percutaneous coronary intervention, or heart failure.

Patients who have undergone a surgical procedure which includes an indication for cardiac rehabilitation (coronary artery bypass surgery, heart valve repair/replacement, or heart transplant)

Must not have

Patients referred to cardiac rehab with ventricular assist devices.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if doing cardiac rehab at home is just as effective as coming in to the clinic.

Who is the study for?

This trial is for heart patients with conditions like a recent heart attack, angina, or those who've had certain heart surgeries. Participants need to have access to a smartphone or computer with internet and an email address. It's not for those using ventricular assist devices.

What is being tested?

The study is testing if cardiac rehabilitation done at home (with or without clinic visits) can be as effective as the traditional approach of only attending sessions in a medical center.

What are the potential side effects?

Since this trial involves non-drug interventions like exercise and education programs, side effects may include typical risks associated with physical activity such as muscle soreness or strain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a history of heart issues, including heart attack, stable chest pain, heart surgery, or heart failure.

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I had heart surgery that requires cardiac rehab.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a ventricular assist device and am referred to cardiac rehab.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Functional Capacity

Number of participants who are re-hospitalized during the trial

Secondary study objectives

6 Minute Walk Test

Change in Body Weight

Fasting Basic Lipid Panel

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Active Control

Group I: Conventional Center-Based Cardiac Rehab + mHealth (CON+)Active Control2 Interventions

Participants will be prescribed 36 sessions of center-based CR as noted above. In addition, participants will be provided access to the mHealth platform which provides "e-Learning modules" with factsheets, videos, quizzes, and questionnaires (coinciding with activities being conducted during the CON program), a Social Network Module will allow patients to communicate via secure network with other patients who are part of their invited network. The Social Network Module also allows for secure two-way interaction with healthcare providers in the event that patients are experiencing signs or symptoms suggestive of worsening condition. This platform also contains a Personal Health Record Module allowing patients to upload, archive, and retrieve personal health data (e.g. fitness tracker data, heart rate monitor data, blood pressure recordings, etc.) and record vital signs, symptoms, treatments, and medical history.

Group II: Conventional Center-Based Cardiac Rehab (CON)Active Control1 Intervention

Participants will be prescribed 36 sessions of center-based CR. This includes supervised exercise sessions, cooking demonstrations, didactic lectures, video presentations, group support, and stress management education. During sessions, participants have direct access to the medical director, case manager, registered nurse, exercise physiologist, and stress management specialists.

Group III: Home-Based Cardiac Rehab + mHealth (HOM+)Active Control2 Interventions

Participants will be provided paper copies of educational content at the time of event/discharge. In addition, these participants will be provided access to the same mHealth platform as the CON+ group. Participants in this group will be encouraged to exercise three days per week while also completing the additional questionnaires and educational content provided by the mHealth platform in accordance with the CR program. Participation will be tracked using web/internet analytics.

0 / 3Eligibility criteria met