Impact of a Corrie Cardiac Rehabilitation Program (mTECH-Rehab)

Impact of a Mobile Technology Enabled Corrie Cardiac Rehabilitation Program on Functional Status and Cardiovascular Outcomes (mTECH-Rehab): A Randomized Controlled Trial

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 Overview

• Status: Completed
• Conditions: Myocardial Infarction; Myocardial Ischemia; Coronary Artery Disease; Valve Heart Disease; Coronary Artery Occlusion; Bypass Graft Occlusion; Coronary Artery Stenosis Stent
• Intervention / Treatment: Combination product: Corrie Hybrid Cardiac Rehabilitation Program

• Study Type: Interventional
• Enrollment (Actual): 259
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 years or older
• Individuals admitted to the hospital for the following conditions or interventions during the index admission: Acute myocardial infarction (STEMI or NSTEMI type 1), Coronary artery bypass grafting (CABG), and Coronary artery angioplasty/stenting (PCI), Heart valve surgery, catheter-based aortic valve replacement (TAVR).

Exclusion Criteria

• Non-English speaking
• Symptomatic severe aortic stenosis or other severe valvular disease
• Physical disability that would preclude safe and adequate exercise performance
• Hypertrophic obstructive cardiomyopathy with peak resting left ventricular outflow gradient of >25 mmHg
• Known aortic dissection
• Severe resting arterial hypertension (Systolic blood pressure >200 mmHg or diastolic BP >110mmHg) at baseline assessment
• Mental impairment leading to inability to cooperate with study procedures
• Untreated high degree atrioventricular block
• Atrial fibrillation with uncontrolled ventricular rate (Heart rate >110 at rest) at baseline assessment
• History of cardiac arrest or sudden death
• Myocardial infarction or cardiac surgery complications with cardiogenic shock and/or congestive heart failure and/or signs/symptoms of post-procedure ischemia
• Left ventricular ejection fraction <40%
• History of Clinically significant depression
• Visual or hearing impairment which precludes the use of the intervention
• Presence of cardiac defibrillator
• Incomplete revascularization procedure
• History of one or more episodes of falls in the last year

• Pregnancy

  • If patients are deemed clinically unstable and unable to participate at the time of initial screening, the research team member may return at a later date to determine whether this status has changed.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group); Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.	Combination product: Corrie Hybrid Cardiac Rehabilitation Program; 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.
No Intervention: Facilitated Center-Based Cardiac Rehabilitation Program (Control Group); Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks after randomization
Blood Pressure (mmHg)	Systolic blood pressure and Diastolic blood pressure	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	12 weeks after randomization
Glycosylated Hemoglobin (HbA1c)	Glycosylated hemoglobin (HbA1c) level (%) measured through blood sample drawn at 12 week follow up visit	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.	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.	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).	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)	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).	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).	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).	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).	12 weeks after randomization
Tobacco Use	Tobacco use categories (Cardiovascular secondary health metric component). Ideal (never). Intermediate (Former smoker). Poor (Recent/Current smoker).	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).	12 weeks after randomization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression as Assessed by the Patient Health Questionnaire 8	The difference in depressive symptoms as measured by Patient Health Questionnaire 8 (PHQ 8): The 8 item questionnaire administered at 12 weeks with the following scoring system: Score range 0-24. A score of 10 or greater is considered major depression, 20 or more is severe major depression. Note, as an exploratory outcome, only a subgroup of participants responded to this survey request.	12 weeks after randomization
Anxiety as Assessed by the Generalized Anxiety Disorder 7	The difference in anxiety level as measured by Generalized Anxiety Disorder 7 (GAD 7): The 7-item questionnaire administered at 12 weeks follow up with the following scoring system. Each item is assigned scores of 0, 1, 2, and 3 to the response categories. GAD-7 total score for the seven items ranges from 0 to 21. 0-4: minimal anxiety 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety.	12 weeks after randomization
Stress as Assessed by the Perceived Stress Scale-10	The difference in stress level as measured by Perceived Stress Scale (PSS -10): The 10 item questionnaire administered at 12 weeks follow up. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.	12 weeks after randomization
Health Literacy as Assessed by the (e) Health Literacy Scale (eHEALS)	The difference in Health Literacy as measured by The (e) Health Literacy Scale (eHEALS): The 8 item scale administered at 12 weeks follow up. Total scores of the eHEALS range from 8 to 40, with higher scores representing higher self-perceived (e) Health literacy.	12 weeks after randomization
Patient Activation as Assessed by the Patient Activation Measure 10	The difference in patient activation as measured by Patient Activation Measure 10 (PAM 10): The 10-item five-point Likert scale for assessing patient activation at 12 weeks follow up, indicating whether the patient possesses the necessary knowledge, skills, and confidence needed for self-care. The total score reference range is from 0 to 100, where higher scores indicate greater patient activation and ability for self-care.	12 weeks after randomization
User Engagement as Assessed by the Number of App Interactions (Intervention Group Only)	Number of interactions in the smartphone app per participant, collected via the Corrie Health Platform User Analytics at 12 weeks follow up (only assessed in intervention arm).	12 weeks after randomization

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: American Heart Association; Apple Inc.
• Investigators: Principal Investigator: Lena Mathews, MD, MHS, Johns Hopkins University

Publications and helpful links

General Publications

• Isakadze N, Kim CH, Marvel FA, Ding J, MacFarlane Z, Gao Y, Spaulding EM, Stewart KJ, Nimbalkar M, Bush A, Broderick A, Gallagher J, Molello N, Commodore-Mensah Y, Michos ED, Dunn P, Hanley DF, McBee N, Martin SS, Mathews L. Rationale and Design of the mTECH-Rehab Randomized Controlled Trial: Impact of a Mobile Technology Enabled Corrie Cardiac Rehabilitation Program on Functional Status and Cardiovascular Health. J Am Heart Assoc. 2024 Jan 16;13(2):e030654. doi: 10.1161/JAHA.123.030654. Epub 2024 Jan 16.

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2023
• Primary Completion (Actual): October 14, 2024
• Study Completion (Actual): October 14, 2024

Study Registration Dates

• First Submitted: February 3, 2022
• First Submitted That Met QC Criteria: February 3, 2022
• First Posted (Actual): February 14, 2022

Study Record Updates

• Last Update Posted (Actual): December 5, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: self-management; guideline adherence; digital health; community engagement; smartphone app; behavior modification
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Ischemia; Pathological Conditions, Signs and Symptoms; Coronary Artery Disease; Myocardial Ischemia; Myocardial Infarction; Heart Valve Diseases; Coronary Occlusion
• Other Study ID Numbers: IRB00308410

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified, aggregate level results, including primary and secondary outcomes, and the data dictionary will be shared through clinicaltrials.gov. Study documents (study protocol, statistical analysis plan, informed consent form, analytic code) will also be shared upon request.
• IPD Sharing Time Frame: IPD will be made available upon request for up to 3 years from the study completion date (to 10/14/2027).
• IPD Sharing Access Criteria: Researchers must submit a letter of intention and formal data request to the mTECH-Rehab principal investigator, who will review the request with the core study team and grant approval based on evaluation of merit.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No