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

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Acute Coronary Syndrome; Percutaneous Coronary Intervention; Stable Angina Pectoris; Acute Myocardial Infarction
• Intervention / Treatment: Other: Center-Based Cardiac Rehab; Other: mHealth; Other: Home-Based 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 Type: Interventional
• Enrollment (Estimated): 333
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thomas P Olson, Ph.D., M.S.; Phone Number: 507-284-4441; Email: olson.thomas2@mayo.edu
• Study Contact Backup: Name: Subban Hassan; Phone Number: 507-255-0607; Email: Hassan.Subban@mayo.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Not yet recruiting
      • University of Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic
      • Principal Investigator: Thomas P Olson, Ph.D; M.S.
      • Contact: Subban Hassan; Phone Number: 507-255-0607; Email: Hassan.Subban@mayo.edu

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

3

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
Functional Capacity	VO2 peak	3 Months
Number of participants who are re-hospitalized during the trial	We will look at the number of patients who are hospitalized for any reason during the follow-up period	1 Year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Body Weight	body weight will be measured from pre to post intervention to see if weight decreases	3 Months
Fasting Basic Lipid Panel	All fasting blood chemistry measures will be conducted by standard clinical protocols in the Mayo Clinic laboratories. These measures will be conducted at the time of enrollment in the research program and during each of the two follow-up study visits.	3 Months
Fasting Blood Glucose	All fasting blood chemistry measures will be conducted by standard clinical protocols in the Mayo Clinic laboratories. These measures will be conducted at the time of enrollment in the research program and during each of the two follow-up study visits.	3 Months
Fasting Hemoglobin	All fasting blood chemistry measures will be conducted by standard clinical protocols in the Mayo Clinic laboratories. These measures will be conducted at the time of enrollment in the research program and during each of the two follow-up study visits.	3 Months
Fasting Hemoglobin A1C	All fasting blood chemistry measures will be conducted by standard clinical protocols in the Mayo Clinic laboratories. These measures will be conducted at the time of enrollment in the research program and during each of the two follow-up study visits.	3 Months
6 Minute Walk Test	exercise capacity	3 Months
Self-Reported Physical Activity	assessed via IPAQ questionnaire	3 Months
Self-Reported Physical Activity	assessed via DASI questionnaire	3 Months
Self-Reported Dietary Patterns	obtained using a standard food frequency questionnaire	3 Months
Self-Reported Quality of Life	Assessed using PHQ-9	3 Months
Self-Reported Quality of Life	Assessed using Darmouth 9-item short-form health survey	3 Months

Collaborators and Investigators

• 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

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2021
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 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): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Cardiac Rehabilitation
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Myocardial Infarction; Infarction; Acute Coronary Syndrome; Angina Pectoris; Angina, Stable
• 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