Improving Cardiac Rehabilitation Outcomes Through Mobile Case Management (iCARE)

Mayo Clinic

Status: Completed

Conditions: Percutaneous Coronary Intervention; Acute Coronary Syndrome; Stable Angina Pectoris; Heart Failure; Acute Myocardial Infarction

Treatments: Other: Home-Based Cardiac Rehab; Other: mHealth; Other: Center-Based Cardiac Rehab

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04938661

R01NR018832 (U.S. NIH Grant/Contract)

20-002258

Details and patient eligibility

About

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.

Full 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.

Enrollment: 206 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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206 participants in 3 patient groups

Conventional Center-Based Cardiac Rehab (CON)

Active Comparator group

Description:

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.

Treatment:

Other: Center-Based Cardiac Rehab

Conventional Center-Based Cardiac Rehab + mHealth (CON+)

Active Comparator group

Description:

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.

Treatment:

Other: Center-Based Cardiac Rehab

Other: mHealth

Home-Based Cardiac Rehab + mHealth (HOM+)

Active Comparator group

Description:

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.

Treatment:

Other: mHealth

Other: Home-Based Cardiac Rehab