Improving Cardiac Rehabilitation Outcomes Through Mobile Case Management (iCARE) (iCARE)

April 6, 2026 updated by: Thomas P. Olson, M.S., Ph.D., Mayo Clinic
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

206

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional Center-Based Cardiac Rehab (CON)
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.
Other: Center-Based Cardiac Rehab
36 center-Based Cardiac Rehab Sessions
Active Comparator: Conventional Center-Based Cardiac Rehab + mHealth (CON+)
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.
Other: Center-Based Cardiac Rehab
36 center-Based Cardiac Rehab Sessions
Other: mHealth
Mobile Health Platform
Active Comparator: Home-Based Cardiac Rehab + mHealth (HOM+)
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.
Other: mHealth
Mobile Health Platform
Other: Home-Based Cardiac Rehab
Encouraged to exercise 3 times per week at home

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline; 3 Months
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.
1 Year
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.
Baseline to 3 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Body Mass Index
Time Frame: Baseline; 3 Months
The change in body mass index (BMI) measured from baseline to 3 months.
Baseline; 3 Months
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.
Baseline; 3 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Thomas P Olson, Ph.D., M.S., Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 8, 2021

Primary Completion (Actual)

April 10, 2025

Study Completion (Actual)

June 9, 2025

Study Registration Dates

First Submitted

May 14, 2021

First Submitted That Met QC Criteria

June 22, 2021

First Posted (Actual)

June 24, 2021

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-002258
  • R01NR018832 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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