Improving Cardiac Rehabilitation Outcomes Through Mobile Case Management (iCARE)
iCARE
2 other identifiers
interventional
206
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2021
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2021
CompletedFirst Posted
Study publicly available on registry
June 24, 2021
CompletedStudy Start
First participant enrolled
July 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 10, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 9, 2025
CompletedResults Posted
Study results publicly available
April 27, 2026
CompletedApril 27, 2026
April 1, 2026
3.8 years
May 14, 2021
April 6, 2026
April 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
Baseline; 3 Months
Number of Participants Who Were Re-hospitalized During the Trial
The number of participants who were re-hospitalized during the trial.
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.
Baseline to 3 Months
Secondary Outcomes (2)
Change in Body Mass Index
Baseline; 3 Months
Change in Self-Reported Quality of Life
Baseline; 3 Months
Study Arms (3)
Conventional Center-Based Cardiac Rehab (CON)
ACTIVE COMPARATORParticipants 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 COMPARATORParticipants 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 COMPARATORParticipants 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.
Interventions
36 center-Based Cardiac Rehab Sessions
Mobile Health Platform
Encouraged to exercise 3 times per week at home
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Patients referred to cardiac rehab with ventricular assist devices.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- National Institute of Nursing Research (NINR)collaborator
Study Sites (2)
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Thomas Olson, Ph.D., M.S.
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas P Olson, Ph.D., M.S.
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
May 14, 2021
First Posted
June 24, 2021
Study Start
July 8, 2021
Primary Completion
April 10, 2025
Study Completion
June 9, 2025
Last Updated
April 27, 2026
Results First Posted
April 27, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share