In this randomized clinical trial, the researchers are investigating whether a multi-component virtual/hybrid cardiac rehabilitation program will improve functional status, cholesterol level, overall cardiovascular health, individual risk factors, quality of life and mental health for patients who have recently been diagnosed with myocardial infarction, received a coronary stent, underwent heart surgery or catheter-based valve replacement, as compared to traditional, center-based cardiac rehabilitation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
259
The Corrie Hybrid Cardiac Rehabilitation Program is a multi-component intervention. It consists of the Corrie smartphone app for cardiovascular health optimization which is paired with wristband device (Apple Watch or Fitbit), Bluetooth-enabled Omron blood pressure monitor and exercise resistance bands. The program also includes individualized treatment plan development, setting health goals and communication with trained Corrie Health Coach. Furthermore, the intervention includes motivational text messages sent to participants throughout the study to aid with risk factor modification.
Johns Hopkins University
Baltimore, Maryland, United States
6-minute Walking Distance (Meters)
Mean difference in 6 minute walk distance, between Intervention and Control groups, as measured at final study visit occurring at 12 weeks after randomization.
Time frame: 12 weeks after randomization
Composite Cardiovascular Health Metric for Secondary Prevention
The cardiovascular health metric for secondary prevention (adapted from American Heart Association's Life Simple 7). The score ranges from 0 to 14 with higher score indicating better cardiovascular health.
Time frame: 12 weeks after randomization
Blood Pressure (mmHg)
Systolic blood pressure and Diastolic blood pressure
Time frame: 12 weeks after randomization
Low Density Lipoprotein - Cholesterol (LDL-C)
LDL cholesterol level (in mg/dl) measured through blood sample drawn at 12 week follow up visit
Time frame: 12 weeks after randomization
Glycosylated Hemoglobin (HbA1c)
Glycosylated hemoglobin (HbA1c) level (%) measured through blood sample drawn at 12 week follow up visit
Time frame: 12 weeks after randomization
Body Mass Index (kg/m^2)
BMI = weight (kg) / height in meters squared (m\^2). Weight and height measured by study staff at study visit.
Time frame: 12 weeks after randomization
Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10: The 10-item patient-reported questionnaire administered at 12 weeks follow up in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.
Time frame: 12 weeks after randomization
Blood Pressure Control
Blood pressure control (Cardiovascular secondary health metric component). Ideal (SBP \<130 mmHg and DBP \<90 mmHg). Intermediate (SBP 130-139 mmHg or DBP 80-89 mmHg). Poor (SBP ≥140 mmHg or DBP ≥90 mmHg).
Time frame: 12 weeks after randomization
Cholesterol (LDL-C) Control
Cholesterol (LDL-C) control (Cardiovascular secondary health metric component). Ideal (LDL-C \<70mg/dL). Intermediate (LDL-C 70-99 mg/dL). Poor (LDL-C ≥100mg/dL)
Time frame: 12 weeks after randomization
Diabetes Control
Diabetes (HbA1c) control (Cardiovascular secondary health metric component). Ideal (HbA1c \<7% for diabetic, \<5.7% for non-diabetic). Intermediate (HbA1c 7.0-7.9% for diabetic, 5.0-5.9% for non-diabetic). Poor (HbA1c ≥8% for diabetic, ≥6.5% for non-diabetic).
Time frame: 12 weeks after randomization
Weight (BMI) Categories
Weight (BMI) categories (Cardiovascular secondary health metric component). Ideal (BMI \<25 kg/m\^2). Intermediate (BMI 25-29 kg/m\^2). Poor (BMI ≥ 30 kg/m\^2).
Time frame: 12 weeks after randomization
Physical Activity Categories
Physical activity categories (Cardiovascular secondary health metric component). Ideal (≥150 min/wk moderate physical activity, ≥75 min/wk vigorous physical activity). Intermediate (1-149 min/wk moderate physical activity, 1-74 min/wk vigorous physical activity). Poor (No regular exercise).
Time frame: 12 weeks after randomization
Diet Categories
Diet categories (Cardiovascular secondary health metric component). Ideal (Rate Your Plate score 64-81). Intermediate (Rate Your Plate score 46-63). Poor (Rate Your Plate score 27-45).
Time frame: 12 weeks after randomization
Tobacco Use
Tobacco use categories (Cardiovascular secondary health metric component). Ideal (never). Intermediate (Former smoker). Poor (Recent/Current smoker).
Time frame: 12 weeks after randomization
Cardiac Rehabilitation Engagement
Cardiac rehabilitation engagement as measured by number of participants who attended the sessions per category. Grouped by Healthcare Effectiveness Data and Information Set (HEDIS) categories: Initiation (0-12 sessions attended), Engagement 1 (13-24 sessions attended), Engagement 2 (25-36 sessions attended).
Time frame: 12 weeks after randomization
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