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OpenTrials
Completed

NCT Number: NCT04938661

Improving Cardiac Rehabilitation Outcomes Through Mobile Case Management (iCARE)

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.

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Key information

Conditions

Acute Myocardial Infarction Acute Coronary Syndrome Angina Pectoris Angina, Stable Cardiovascular Diseases Chest Pain Heart Diseases Heart Failure Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Percutaneous Coronary Intervention Signs and Symptoms Stable Angina Pectoris Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota, Minneapolis, Minnesota, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Center-Based Cardiac Rehab

Other

36 center-Based Cardiac Rehab Sessions

mHealth

Other

Mobile Health Platform

Home-Based Cardiac Rehab

Other

Encouraged to exercise 3 times per week at home

Primary outcomes

  1. Change in Metabolic Equivalents of Task (METS)

    Time frame: Baseline; 3 Months

    The change in metabolic equivalents of task (METS) assessed by measuring the energy the body uses during activity relative to resting energy expenditure.

  2. Number of Participants Who Were Re-hospitalized During the Trial

    Time frame: 1 Year

    The number of participants who were re-hospitalized during the trial.

  3. Adherence to the Intervention

    Time frame: Baseline to 3 Months

    The percentage of completed visits per participant that were attended from the start of the intervention (baseline) to the end of the intervention (3 months) relative to the number of prescribed visits per participant.

Secondary outcomes

  1. Change in Body Mass Index

    Time frame: Baseline; 3 Months

    The change in body mass index (BMI) measured from baseline to 3 months.

  2. Change in Self-Reported Quality of Life

    Time frame: Baseline; 3 Months

    The change in self-reported quality of life assessed using the Patient Health Questionnaire 9-item (PHQ-9) scale used to assess severity of depression. Scoring is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." Total score ranges from 0 to 27 where 0 is no depression, 1-4 is minimal depression, 5-9 is mild depression, 10-14 is moderate depression, and 15-19 is moderately severe depression and 20-27 severe depression.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Acronym: iCARE

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jun 24, 2021
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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