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Coronary Artery DiseasemTECH-RehabNCT05238103

Impact of a Corrie Cardiac Rehabilitation Program

A study testing Corrie Hybrid Cardiac Rehabilitation Program in people with Coronary Artery Disease and Myocardial Infarction, run by Johns Hopkins University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Corrie Hybrid Cardiac Rehabilitation Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
259 participants
Where
1 siteUnited States
Study dates
3 Apr 2023to 14 Oct 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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
Show all 19Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Johns Hopkins University

    Baltimore, Maryland, 21287

Other trials in United States

About this study

Official title: 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.

Being tested
Corrie Hybrid Cardiac Rehabilitation Program
Keywords
digital health, smartphone app, self-management, guideline adherence, behavior modification, community engagement
Medical subject headings
Coronary Artery Disease, Myocardial Infarction, Myocardial Ischemia, Coronary Occlusion, Heart Valve Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Corrie Hybrid Cardiac Rehabilitation ProgramCombination 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.

Study groups in NCT05238103
Study groupRoleWhat they receive
Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group)ExperimentalReceives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation.
Receives: Combination Product: Corrie Hybrid Cardiac Rehabilitation Program
Facilitated Center-Based Cardiac Rehabilitation Program (Control Group)No interventionReceives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 weeks after randomization

Secondary outcomes (14)

  1. 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.

    Measured: 12 weeks after randomization

  2. Blood Pressure (mmHg)

    Systolic blood pressure and Diastolic blood pressure

    Measured: 12 weeks after randomization

  3. Low Density Lipoprotein - Cholesterol (LDL-C)

    LDL cholesterol level (in mg/dl) measured through blood sample drawn at 12 week follow up visit

    Measured: 12 weeks after randomization

  4. Glycosylated Hemoglobin (HbA1c)

    Glycosylated hemoglobin (HbA1c) level (%) measured through blood sample drawn at 12 week follow up visit

    Measured: 12 weeks after randomization

  5. 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.

    Measured: 12 weeks after randomization

  6. 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.

    Measured: 12 weeks after randomization

  7. 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).

    Measured: 12 weeks after randomization

  8. 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)

    Measured: 12 weeks after randomization

  9. 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).

    Measured: 12 weeks after randomization

  10. 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).

    Measured: 12 weeks after randomization

  11. 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).

    Measured: 12 weeks after randomization

  12. 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).

    Measured: 12 weeks after randomization

  13. Tobacco Use

    Tobacco use categories (Cardiovascular secondary health metric component). Ideal (never). Intermediate (Former smoker). Poor (Recent/Current smoker).

    Measured: 12 weeks after randomization

  14. 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).

    Measured: 12 weeks after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2022
  2. Study start3 Apr 2023
  3. Primary completion14 Oct 2024
  4. Study completion14 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
259 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05238103
Sponsor's protocol ID
IRB00308410
Acronym
mTECH-Rehab
Status last verified
Nov 2025
First submitted
3 Feb 2022
Last updated
5 Dec 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: 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.

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.

    PubMed 38226511

Questions about this trial

What is this clinical trial studying?

A study testing Corrie Hybrid Cardiac Rehabilitation Program in people with Coronary Artery Disease and Myocardial Infarction, run by Johns Hopkins University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6-minute Walking Distance (Meters) (time frame: 12 weeks after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05238103, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.

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