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OpenTrials
Completed

NCT Number: NCT05238103

Impact of a Corrie Cardiac Rehabilitation Program

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 6-minute Walking Distance (Meters)

    Time frame: 12 weeks after randomization

    Mean difference in 6 minute walk distance, between Intervention and Control groups, as measured at final study visit occurring at 12 weeks after randomization.

Secondary outcomes

  1. Composite Cardiovascular Health Metric for Secondary Prevention

    Time frame: 12 weeks after randomization

    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.

  2. Blood Pressure (mmHg)

    Time frame: 12 weeks after randomization

    Systolic blood pressure and Diastolic blood pressure

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

    Time frame: 12 weeks after randomization

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

  4. Glycosylated Hemoglobin (HbA1c)

    Time frame: 12 weeks after randomization

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

  5. Body Mass Index (kg/m^2)

    Time frame: 12 weeks after randomization

    BMI = weight (kg) / height in meters squared (m^2). Weight and height measured by study staff at study visit.

  6. Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10

    Time frame: 12 weeks after randomization

    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.

  7. Blood Pressure Control

    Time frame: 12 weeks after randomization

    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).

  8. Cholesterol (LDL-C) Control

    Time frame: 12 weeks after randomization

    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)

  9. Diabetes Control

    Time frame: 12 weeks after randomization

    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).

  10. Weight (BMI) Categories

    Time frame: 12 weeks after randomization

    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).

  11. Physical Activity Categories

    Time frame: 12 weeks after randomization

    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. Diet Categories

    Time frame: 12 weeks after randomization

    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).

  13. Tobacco Use

    Time frame: 12 weeks after randomization

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

  14. Cardiac Rehabilitation Engagement

    Time frame: 12 weeks after randomization

    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).

Other outcomes

  1. Depression as Assessed by the Patient Health Questionnaire 8

    Time frame: 12 weeks after randomization

    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.

  2. Anxiety as Assessed by the Generalized Anxiety Disorder 7

    Time frame: 12 weeks after randomization

    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.

  3. Stress as Assessed by the Perceived Stress Scale-10

    Time frame: 12 weeks after randomization

    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.

  4. Health Literacy as Assessed by the (e) Health Literacy Scale (eHEALS)

    Time frame: 12 weeks after randomization

    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.

  5. Patient Activation as Assessed by the Patient Activation Measure 10

    Time frame: 12 weeks after randomization

    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.

  6. User Engagement as Assessed by the Number of App Interactions (Intervention Group Only)

    Time frame: 12 weeks after randomization

    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).

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • American Heart Association
  • Apple Inc.

Registry information

Official study title

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

Acronym: mTECH-Rehab

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 14, 2022
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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