Improving Cardiac Rehabilitation Outcomes Through Mobile Case Management (iCARE)

Last updated: September 4, 2024
Sponsor: Mayo Clinic
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Defect

Chest Pain

Blood Clots

Treatment

mHealth

Center-Based Cardiac Rehab

Home-Based Cardiac Rehab

Clinical Study ID

NCT04938661
20-002258
R01NR018832
  • Ages 18-80
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 myocardialinfarction/acute coronary syndrome, stable angina pectoris, percutaneous coronaryintervention, or heart failure.

  • Patients who have undergone a surgical procedure which includes an indication forcardiac rehabilitation (coronary artery bypass surgery, heart valverepair/replacement, or heart transplant)

Exclusion

Exclusion Criteria:

  • Patients referred to cardiac rehab with ventricular assist devices.

Study Design

Total Participants: 333
Treatment Group(s): 3
Primary Treatment: mHealth
Phase:
Study Start date:
July 08, 2021
Estimated Completion Date:
September 30, 2026

Study 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.

Connect with a study center

  • University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

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