Improving Cardiac Rehabilitation Outcomes Through Mobile Case Management (iCARE)

Heart Failure Clinical Trial

— iCARE  

Official title:

Improving Cardiac Rehabilitation Outcomes Through Mobile Case Management (iCARE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04938661
• Other study ID #: 20-002258
• Secondary ID: R01NR018832
• Status: Recruiting
• Phase: N/A
• Start date: July 8, 2021
• Est. completion date: August 2025

Study information

• Verified date: August 2023
• Source: Mayo Clinic
• Contact: Thomas P Olson, Ph.D., M.S.
• Phone: 507-284-4441
• Email: olson.thomas2[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 333
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Myocardial Infarction
• Angina Pectoris
• Angina, Stable
• Heart Failure
• Infarction
• Myocardial Infarction
• Percutaneous Coronary Intervention
• Stable Angina Pectoris

Intervention

Other:
• Center-Based Cardiac Rehab
36 center-Based Cardiac Rehab Sessions
• mHealth
Mobile Health Platform
• Home-Based Cardiac Rehab
Encouraged to exercise 3 times per week at home

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Capacity	VO2 peak	3 Months
Primary	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	Change in Body Weight	body weight will be measured from pre to post intervention to see if weight decreases	3 Months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	6 Minute Walk Test	exercise capacity	3 Months
Secondary	Self-Reported Physical Activity	assessed via IPAQ questionnaire	3 Months
Secondary	Self-Reported Physical Activity	assessed via DASI questionnaire	3 Months
Secondary	Self-Reported Dietary Patterns	obtained using a standard food frequency questionnaire	3 Months
Secondary	Self-Reported Quality of Life	Assessed using PHQ-9	3 Months
Secondary	Self-Reported Quality of Life	Assessed using Darmouth 9-item short-form health survey	3 Months

External Links

•   Mayo Clinic Clinical Trials