Clinical trial NCT04938661: Improving Cardiac Rehabilitation Outcomes Through Mobile Case Management (iCARE)
Official title: Improving Cardiac Rehabilitation Outcomes Through Mobile Case Management (iCARE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Myocardial Infarction
Acute Coronary Syndrome
Stable Angina Pectoris
Percutaneous Coronary Intervention
Heart Failure
Keywords: Cardiac Rehabilitation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2021-06-24
Enrollment: 333
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Functional Capacity
timeFrame: 3 Months
measure: Number of participants who are re-hospitalized during the trial
timeFrame: 1 Year
Secondary outcomes:
measure: Change in Body Weight
timeFrame: 3 Months
measure: Fasting Basic Lipid Panel
timeFrame: 3 Months
measure: Fasting Blood Glucose
timeFrame: 3 Months
measure: Fasting Hemoglobin
timeFrame: 3 Months
measure: Fasting Hemoglobin A1C
timeFrame: 3 Months
measure: 6 Minute Walk Test
timeFrame: 3 Months
measure: Self-Reported Physical Activity
timeFrame: 3 Months
measure: Self-Reported Physical Activity
timeFrame: 3 Months
measure: Self-Reported Dietary Patterns
timeFrame: 3 Months
measure: Self-Reported Quality of Life
timeFrame: 3 Months
measure: Self-Reported Quality of Life
timeFrame: 3 Months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Thomas P Olson, Ph.D., M.S.
role: PRINCIPAL_INVESTIGATOR
References: