Acute Myocardial InfarctioniCARENCT04938661
Improving Cardiac Rehabilitation Outcomes Through Mobile Case Management (iCARE)
A study testing Center-Based Cardiac Rehab, mHealth and Home-Based Cardiac Rehab in people with Acute Myocardial Infarction and Acute Coronary Syndrome, run by Mayo Clinic at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Myocardial Infarction, Acute Coronary Syndrome, Stable Angina Pectoris
- What is being tested?
- Center-Based Cardiac Rehab, mHealth and Home-Based Cardiac Rehab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Jul 2021to 9 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Patients referred to cardiac rehab with ventricular assist devices.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Minnesota
Minneapolis, Minnesota, 55455
Mayo Clinic
Rochester, Minnesota, 55905
About this study
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.
Read the 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
- Being tested
- Center-Based Cardiac Rehab, mHealth, Home-Based Cardiac Rehab
- Keywords
- Cardiac Rehabilitation
- Medical subject headings
- Acute Coronary Syndrome, Angina, Stable, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Center-Based Cardiac RehabOther
36 center-Based Cardiac Rehab Sessions
mHealthOther
Mobile Health Platform
Home-Based Cardiac RehabOther
Encouraged to exercise 3 times per week at home
| Study group | Role | What they receive |
|---|---|---|
| Conventional Center-Based Cardiac Rehab (CON) | Active comparator | 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. Receives: Other: Center-Based Cardiac Rehab |
| Conventional Center-Based Cardiac Rehab + mHealth (CON+) | Active comparator | 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. Receives: Other: Center-Based Cardiac Rehab; Other: mHealth |
| Home-Based Cardiac Rehab + mHealth (HOM+) | Active comparator | 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. Receives: Other: mHealth; Other: Home-Based Cardiac Rehab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Metabolic Equivalents of Task (METS)
The change in metabolic equivalents of task (METS) assessed by measuring the energy the body uses during activity relative to resting energy expenditure.
Measured: Baseline; 3 Months
Number of Participants Who Were Re-hospitalized During the Trial
The number of participants who were re-hospitalized during the trial.
Measured: 1 Year
Adherence to the Intervention
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.
Measured: Baseline to 3 Months
Secondary outcomes (2)
Change in Body Mass Index
The change in body mass index (BMI) measured from baseline to 3 months.
Measured: Baseline; 3 Months
Change in Self-Reported Quality of Life
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.
Measured: Baseline; 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start8 Jul 2021
- Primary completion10 Apr 2025
- Study completion9 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Thomas P. Olson, M.S., Ph.D., Mayo Clinic
- Investigators
- Thomas P Olson, Ph.D., M.S., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04938661
- Sponsor's protocol ID
- 20-002258
- Other IDs
- R01NR018832
- Acronym
- iCARE
- Status last verified
- Apr 2026
- First submitted
- 14 May 2021
- Last updated
- 27 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Cardiac Rehabilitation Outcomes Through Mobile Case Management (iCARE)
- ClinicalTrials.gov ID
- NCT04938661
- Acronym / sponsor ID
- iCARE / 20-002258
- Conditions
- Acute Myocardial Infarction, Acute Coronary Syndrome, Stable Angina Pectoris, Percutaneous Coronary Intervention, Heart Failure
- Keywords
- Cardiac Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 8 Jul 2021 (actual)
- Primary completion
- 10 Apr 2025 (actual)
- Study completion
- 9 Jun 2025 (actual)
- First posted
- 24 Jun 2021 (actual)
- Results
- Posted 27 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional Center-Based Cardiac Rehab (CON) | Active comparator | Other: Center-Based Cardiac RehabParticipants 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. |
| Conventional Center-Based Cardiac Rehab + mHealth (CON+) | Active comparator | Other: Center-Based Cardiac Rehab, Other: mHealthParticipants 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. |
| Home-Based Cardiac Rehab + mHealth (HOM+) | Active comparator | Other: mHealth, Other: Home-Based Cardiac RehabParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (1 listed)
- Patients referred to cardiac rehab with ventricular assist devices.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Center-Based Cardiac Rehab36 center-Based Cardiac Rehab Sessions | Other | Conventional Center-Based Cardiac Rehab (CON), Conventional Center-Based Cardiac Rehab + mHealth (CON+) |
| mHealthMobile Health Platform | Other | Conventional Center-Based Cardiac Rehab + mHealth (CON+), Home-Based Cardiac Rehab + mHealth (HOM+) |
| Home-Based Cardiac RehabEncouraged to exercise 3 times per week at home | Other | Home-Based Cardiac Rehab + mHealth (HOM+) |
Primary outcome
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.
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.
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.
2 secondary outcomes
Change in Body Mass Index
Time frame: Baseline; 3 Months
Change in Self-Reported Quality of Life
Time frame: Baseline; 3 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas P Olson, Ph.D., M.S. principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Center-Based Cardiac Rehab, mHealth and Home-Based Cardiac Rehab in people with Acute Myocardial Infarction and Acute Coronary Syndrome, run by Mayo Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Metabolic Equivalents of Task (METS) (time frame: Baseline; 3 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.