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Improving Cardiac Rehabilitation Outcomes Through Mobile Case Management (iCARE)

Recruiting
18 - 80 years of age
Both
Phase N/A

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Overview

The purpose of this research is to find out if doing cardiac rehab at home, or a mix of cardiac rehab at home and in the clinic, is as effective as coming in to the clinic for cardiac rehab.

Description

To address our specific aims we will use a single-center, prospective, three-arm, parallel group, randomized controlled trial design. At the time of identification of eligibility for participation, patients will be randomized to one of three arms (1:1:1 ratio): Arm 1 consists of patients randomized to conventional cardiac rehab only, Arm 2 consists of patients randomized to conventional cardiac rehab with the addition of the mHealth platform, and Arm 3 consists of patients randomized to remote case management using the mHealth platform only. Clinical metrics will include traditional cardiovascular risk factors with additional tracking of service utilization and adherence, and quality of life. Measures will be made at baseline (pre-intervention) and ~3-months (coinciding with completion of conventional CR). Additional follow-up will occur at 12 months post CR entry. Randomization to study arms will be done with a multidimensional dynamic allocation algorithm, minimizing imbalances in age, sex, body mass index, and race across study arms.

Eligibility

Inclusion Criteria:

  • Own or have reliable access to a smartphone or desktop computer with internet access
  • Have an email address
  • 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)

Exclusion Criteria:

  • Patients referred to cardiac rehab with ventricular assist devices.

Study details

Acute Myocardial Infarction, Acute Coronary Syndrome, Stable Angina Pectoris, Percutaneous Coronary Intervention, Heart Failure

NCT04938661

Mayo Clinic

26 January 2024

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