Impact of a Corrie Cardiac Rehabilitation Program

NCT05238103 | Completed Results FDA Device

• 1 other identifier: IRB00308410
• Study Type: interventional
• Target: 259
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease; Myocardial Infarction; Myocardial Ischemia; Coronary Artery Occlusion; Coronary Artery Stenosis Stent; Bypass Graft Occlusion; Valve Heart Disease

Keywords

digital health; smartphone app; self-management; guideline adherence; behavior modification; community engagement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Composite Cardiovascular Health Metric for Secondary Prevention

  12 weeks after randomization

• Blood Pressure (mmHg)

  12 weeks after randomization

• Low Density Lipoprotein - Cholesterol (LDL-C)

  12 weeks after randomization

• Glycosylated Hemoglobin (HbA1c)

  12 weeks after randomization

• Body Mass Index (kg/m^2)

  12 weeks after randomization

Other Outcomes (6)

• Depression as Assessed by the Patient Health Questionnaire 8

  12 weeks after randomization

• Anxiety as Assessed by the Generalized Anxiety Disorder 7

  12 weeks after randomization

• Stress as Assessed by the Perceived Stress Scale-10

  12 weeks after randomization

Study Arms (2)

Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)

EXPERIMENTAL

Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.

Combination Product: Corrie Hybrid Cardiac Rehabilitation Program

Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)

NO INTERVENTION

Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.

Interventions

Corrie Hybrid Cardiac Rehabilitation Program COMBINATION_PRODUCT

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.

Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• American Heart Association: collaborator
• Apple Inc.: collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

• 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.

  PMID: 38226511 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Infarction; Myocardial Ischemia; Coronary Occlusion; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Results Point of Contact

• Title: Lena Mathews, MD MHS
• Organization: Johns Hopkins University

lmathew6@jhmi.edu

410-502-0469

Study Officials

• Lena Mathews, MD, MHS

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: February 14, 2022
• Study Start: April 3, 2023
• Primary Completion: October 14, 2024
• Study Completion: October 14, 2024
• Last Updated: December 5, 2025
• Results First Posted: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: IPD will be made available upon request for up to 3 years from the study completion date (to 10/14/2027).
• 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.

Locations

US (1)