- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05238103
Impact of a Corrie Cardiac Rehabilitation Program (mTECH-Rehab)
April 17, 2024 updated by: Johns Hopkins University
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 usual care.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chang Kim, MD, PhD
- Phone Number: 4105020469
- Email: ckim148@jhmi.edu
Study Contact Backup
- Name: Lena Mathews, MD, MHS
- Phone Number: 4105500856
- Email: lmathew6@jhmi.edu
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Recruiting
- Johns Hopkins University
-
Contact:
- Lena Mathews, MD, MHS
- Phone Number: 410-550-0856
- Email: lmathew6@jh.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
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.
|
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 |
---|---|---|
The difference in functional status as measured by 6 minute walk test
Time Frame: 16 weeks
|
Conducted on ground level timed for 6 minutes and measuring distance walked in meters and compared at 12 week follow up between intervention vs control arm.
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The difference in Low Density Lipoprotein - Cholesterol (LDL -C) control as measured by the level of LDL - C
Time Frame: 16 weeks
|
LDL cholesterol level measured (in mg/dl) at 12 week follow up visit and compared between the intervention vs control arms.
|
16 weeks
|
The difference in cardiovascular health as measured by composite cardiovascular health Composite metric for secondary prevention
Time Frame: 16 weeks
|
The difference in the composite score of cardiovascular health metric for secondary prevention (adapted from American Heart Association's Life Simple 7) in the intervention vs control arm.
The score ranges from 0 to 14 with higher score indicating better cardiovascular health.
|
16 weeks
|
The difference in cardiac rehabilitation engagement as measured by the proportion of participants attending 12 sessions of total cardiac rehabilitation attended (in person or off site) within 90 days of a cardiovascular event
Time Frame: 16 weeks
|
Proportion of participants attending 12 sessions of total cardiac rehabilitation (in person or off site) within 90 days of a cardiovascular event in intervention arm vs control arm.
|
16 weeks
|
The difference in quality of life as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10
Time Frame: 16 weeks
|
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.
|
16 weeks
|
The difference in blood pressure as measured by systolic blood pressure
Time Frame: 16 weeks
|
Measured by study staff in millimeters of mercury (mmHg) and comparing mean values between intervention and control arm.
|
16 weeks
|
The difference in blood pressure as measured by diastolic blood pressure
Time Frame: 16 weeks
|
Measured by study staff (in mmHg) and comparing mean values between intervention and control arm.
|
16 weeks
|
The difference in adiposity as measured by waist circumference
Time Frame: 16 weeks
|
The difference in mean waist circumference at 12 weeks follow up, measured in centimeters (cm) by study staff.
|
16 weeks
|
The difference in body weight as measured by mean body mass index
Time Frame: 16 weeks
|
As measured by study staff.
BMI = weight (kg) / height in meters squared (m^2).
|
16 weeks
|
The difference in glucose control as measured by glycosylated hemoglobin (Hb A1c) levels
Time Frame: 16 weeks
|
Hb A1c level (percentage) measured at 12 week follow up visit and compared between the intervention vs control arms.
|
16 weeks
|
The difference in lipid profile as measured by mean total cholesterol level
Time Frame: 16 weeks
|
Total cholesterol level measured at 12 week follow up visit and compared between the intervention vs control arms.
|
16 weeks
|
The difference in lipid profile as measured by mean High Density Lipoprotein - Cholesterol (HDL - C) level
Time Frame: 16 weeks
|
High density lipoprotein level measured in mg/dL at 12 week follow up visit and compared between the intervention vs control arms.
|
16 weeks
|
Difference in smoking rates as measured by the proportion of current tobacco users
Time Frame: 16 weeks
|
The difference in proportion of participants who are current tobacco users at 12 weeks per patient report.
|
16 weeks
|
The difference in diet as measured by Rate Your Plate score
Time Frame: 16 weeks
|
A 27 item scale administered at 12 weeks with the following scoring system: 27-45: There are many ways you can make your eating habits healthier. 46-63: There are some ways you can make your eating habits healthier. 64-81: You are making many healthy choices. |
16 weeks
|
The difference in depressive symptoms as measured by Patient Health Questionnaire 8 (PHQ 8)
Time Frame: 16 weeks
|
The 8 item questionnaire administered at 12 weeks with the following scoring system: A score of 10 or greater is considered major depression, 20 or more is severe major depression.
|
16 weeks
|
The difference in anxiety level as measured by Generalized Anxiety Disorder 7 (GAD 7)
Time Frame: 16 weeks
|
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
|
16 weeks
|
The difference in anxiety level as measured by Perceived Stress Scale (PSS -10)
Time Frame: 16 weeks
|
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.
|
16 weeks
|
The difference in patient activation as measured by Patient Activation Measure 10 (PAM 10)
Time Frame: 16 weeks
|
The 10-item five-point Likert scale for assessing patient activation at 12 weeks follow up is used with scoring ranging from 1 to 5 and higher scores indicating the patient possesses the necessary knowledge, skills, and confidence needed for self-care.
The total score reference range is from 0 to 100, where lower scores indicate lower patient activation.
|
16 weeks
|
The difference in Health Literacy as measured by The (e) Health Literacy Scale (eHEALS)
Time Frame: 16 weeks
|
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.
|
16 weeks
|
The difference in safety outcomes as measured by the difference in number of patients requiring hospitalization
Time Frame: 16 weeks
|
Hospitalization as reported in electronic health records or via patient/caregiver report, verified by health records at 12 weeks follow up.
|
16 weeks
|
The difference in safety outcomes as measured by the difference in number of patients Requiring emergency room visits
Time Frame: 16 weeks
|
Emergency room visits as reported in electronic health records or via patient/caregiver report, verified by health records at 12 weeks follow up.
|
16 weeks
|
The difference in safety outcomes as measured by the difference in number of patients with Myocardial infarction
Time Frame: 16 weeks
|
Myocardial infarction as reported in electronic health records or via patient/caregiver report, verified by health records at 12 weeks follow up.
|
16 weeks
|
The difference in safety outcomes as measured by the difference in number of patients with stroke
Time Frame: 16 weeks
|
Stroke as reported in electronic health records or via patient/caregiver report, verified by health records at 12 weeks follow up.
|
16 weeks
|
The difference in safety outcomes as measured by the difference in number of patients who died
Time Frame: 16 weeks
|
Death as reported in electronic health record or via caregiver report, verified by death certificates or health records at 12 weeks follow up.
|
16 weeks
|
The difference in cognitive function as assessed by Montreal Cognitive Assessment (MoCA)
Time Frame: 16 weeks
|
The 30 item test, administered at 12 weeks follow up.
Scores on the MoCA range from 0 to 30.
A score of 26 and higher is considered normal.
|
16 weeks
|
The difference in engagement in in-person cardiac rehabilitation sessions as measured by number of individuals completing in-person cardiac rehabilitation sessions
Time Frame: 16 weeks
|
Number of individuals completing 2, 12, 24 and 36 in person cardiac rehabilitation sessions at 12 weeks follow up.
|
16 weeks
|
Cost of Care as assessed by a Markov Model of Cost-effectiveness
Time Frame: 16 weeks
|
The hospital costs (in US dollars) for emergency department (ED) visits and hospital readmissions will be compared between Corrie Virtual Cardiac Rehabilitation Program and usual care groups at 12 weeks follow up.
|
16 weeks
|
User Engagement as assessed by total number of interactions with smartphone application
Time Frame: 16 weeks
|
Total 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).
|
16 weeks
|
User Engagement as assessed by overall amount of time spent using the smartphone app
Time Frame: 16 weeks
|
Overall amount of time spent using the smartphone app per participant, collected via the Corrie Health Platform User Analytics at 12 weeks follow up (only assessed in intervention arm).
|
16 weeks
|
User Satisfaction as assessed by modified system usability scale
Time Frame: 16 weeks
|
A 10-item five-point Likert scale for assessing systems usability of Corrie Virtual Cardiac Rehabilitation Program at 12 weeks follow up with scoring from 0 to 4 and higher scores meaning patients perceive the system as having global usability.
The total score reference range is from 0 to 100, where lower scores indicate lower perceived application usability.
The investigators will administer system usability scale for different features of Corrie Virtual Cardiac Rehabilitation Program.
|
16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lena Mathews, MD, MHS, Johns Hopkins University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 3, 2023
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
December 1, 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)
April 19, 2024
Last Update Submitted That Met QC Criteria
April 17, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00308410
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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