NCT04938661

Improving Cardiac Rehabilitation Outcomes Through Mobile Case Management (iCARE)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 206 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
OTHER	Center-Based Cardiac Rehab	36 center-Based Cardiac Rehab Sessions
OTHER	mHealth	Mobile Health Platform
OTHER	Home-Based Cardiac Rehab	Encouraged to exercise 3 times per week at home

Timeline

• Start date: 2021-07-08
• Primary completion: 2025-04-10
• Completion: 2025-06-09
• First posted: 2021-06-24
• Last updated: 2025-11-20

Locations

2 sites across 1 country: United States