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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04938661
Other study ID # 20-002258
Secondary ID R01NR018832
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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