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Impact of a Corrie Cardiac Rehabilitation Program (mTECH REHAB)

Primary Purpose

Coronary Artery Disease, Myocardial Infarction, Myocardial Ischemia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Corrie Virtual Cardiac Rehabilitation Program
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Coronary Artery Disease focused on measuring digital health, smartphone app, self-management, guideline adherence, behavior modification, community engagement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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, and coronary artery angioplasty/stenting.

Exclusion Criteria

  • Non-English or non-Spanish 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.

Sites / Locations

  • Johns Hopkins UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Corrie Virtual Cardiac Rehabilitation Program

Usual Care

Arm Description

Receives Corrie Virtual Cardiac Rehabilitation Program and usual care

Receives usual care. Usual care is defined as care according to the patients care team's standard practice

Outcomes

Primary Outcome Measures

The difference in functional status as measured by 6 minute walk test
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.

Secondary Outcome Measures

The difference in Low Density Lipoprotein - Cholesterol (LDL -C) control as measured by the level of LDL - C
LDL cholesterol level measured (in mg/dl) at 12 week follow up visit and compared between the intervention vs control arms.
The difference in cardiovascular health as measured by composite cardiovascular health Composite metric for secondary prevention
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.
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
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.
The difference in quality of life as measured by 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.
The difference in blood pressure as measured by systolic blood pressure
Measured by study staff in millimeters of mercury (mmHg) and comparing mean values between intervention and control arm.
The difference in blood pressure as measured by diastolic blood pressure
Measured by study staff (in mmHg) and comparing mean values between intervention and control arm.
The difference in adiposity as measured by waist circumference
The difference in mean waist circumference at 12 weeks follow up, measured in centimeters (cm) by study staff.
The difference in body weight as measured by mean body mass index
As measured by study staff. BMI = weight (kg) / height in meters squared (m^2).
The difference in glucose control as measured by glycosylated hemoglobin (Hb A1c) levels
Hb A1c level (percentage) measured at 12 week follow up visit and compared between the intervention vs control arms.
The difference in lipid profile as measured by mean total cholesterol level
Total cholesterol level measured at 12 week follow up visit and compared between the intervention vs control arms.
The difference in lipid profile as measured by mean High Density Lipoprotein - Cholesterol (HDL - C) level
High density lipoprotein level measured in mg/dL at 12 week follow up visit and compared between the intervention vs control arms.
Difference in smoking rates as measured by the proportion of current tobacco users
The difference in proportion of participants who are current tobacco users at 12 weeks per patient report.
The difference in diet as measured by Rate Your Plate score
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.
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: A score of 10 or greater is considered major depression, 20 or more is severe major depression.
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
The difference in anxiety 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.
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 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.
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.
The difference in safety outcomes as measured by the difference in number of patients requiring hospitalization
Hospitalization as reported in electronic health records or via patient/caregiver report, verified by health records at 12 weeks follow up.
The difference in safety outcomes as measured by the difference in number of patients Requiring emergency room visits
Emergency room visits as reported in electronic health records or via patient/caregiver report, verified by health records at 12 weeks follow up.
The difference in safety outcomes as measured by the difference in number of patients with Myocardial infarction
Myocardial infarction as reported in electronic health records or via patient/caregiver report, verified by health records at 12 weeks follow up.
The difference in safety outcomes as measured by the difference in number of patients with stroke
Stroke as reported in electronic health records or via patient/caregiver report, verified by health records at 12 weeks follow up.
The difference in safety outcomes as measured by the difference in number of patients who died
Death as reported in electronic health record or via caregiver report, verified by death certificates or health records at 12 weeks follow up.
The difference in cognitive function as assessed by Montreal Cognitive Assessment (MoCA)
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.
The difference in engagement in in-person cardiac rehabilitation sessions as measured by number of individuals completing in-person cardiac rehabilitation sessions
Number of individuals completing 2, 12, 24 and 36 in person cardiac rehabilitation sessions at 12 weeks follow up.
Cost of Care as assessed by a Markov Model of Cost-effectiveness
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.
User Engagement as assessed by total number of interactions with smartphone application
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).
User Engagement as assessed by overall amount of time spent using the smartphone app
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).
User Satisfaction as assessed by modified system usability scale
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.

Full Information

First Posted
February 3, 2022
Last Updated
April 12, 2023
Sponsor
Johns Hopkins University
Collaborators
American Heart Association, Apple Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05238103
Brief Title
Impact of a Corrie Cardiac Rehabilitation Program
Acronym
mTECH REHAB
Official Title
Impact of a Mobile Technology Enabled Corrie Cardiac Rehabilitation Program on Functional Status and Cardiovascular Outcomes (mTECH REHAB): A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 3, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
American Heart Association, Apple Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
In this randomized clinical trial, the researchers are investigating whether a multi-component virtual cardiac rehabilitation program in addition to usual care 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 atherosclerotic cardiovascular disease, as compared to usual care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
504 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Corrie Virtual Cardiac Rehabilitation Program
Arm Type
Experimental
Arm Description
Receives Corrie Virtual Cardiac Rehabilitation Program and usual care
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Receives usual care. Usual care is defined as care according to the patients care team's standard practice
Intervention Type
Combination Product
Intervention Name(s)
Corrie Virtual Cardiac Rehabilitation Program
Intervention Description
The Corrie Virtual Cardiac Rehabilitation Program is multi dimensional 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 Outcome Measure Information:
Title
The difference in functional status as measured by 6 minute walk test
Description
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.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
The difference in Low Density Lipoprotein - Cholesterol (LDL -C) control as measured by the level of LDL - C
Description
LDL cholesterol level measured (in mg/dl) at 12 week follow up visit and compared between the intervention vs control arms.
Time Frame
16 weeks
Title
The difference in cardiovascular health as measured by composite cardiovascular health Composite metric for secondary prevention
Description
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.
Time Frame
16 weeks
Title
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
Description
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.
Time Frame
16 weeks
Title
The difference in quality of life as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10
Description
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.
Time Frame
16 weeks
Title
The difference in blood pressure as measured by systolic blood pressure
Description
Measured by study staff in millimeters of mercury (mmHg) and comparing mean values between intervention and control arm.
Time Frame
16 weeks
Title
The difference in blood pressure as measured by diastolic blood pressure
Description
Measured by study staff (in mmHg) and comparing mean values between intervention and control arm.
Time Frame
16 weeks
Title
The difference in adiposity as measured by waist circumference
Description
The difference in mean waist circumference at 12 weeks follow up, measured in centimeters (cm) by study staff.
Time Frame
16 weeks
Title
The difference in body weight as measured by mean body mass index
Description
As measured by study staff. BMI = weight (kg) / height in meters squared (m^2).
Time Frame
16 weeks
Title
The difference in glucose control as measured by glycosylated hemoglobin (Hb A1c) levels
Description
Hb A1c level (percentage) measured at 12 week follow up visit and compared between the intervention vs control arms.
Time Frame
16 weeks
Title
The difference in lipid profile as measured by mean total cholesterol level
Description
Total cholesterol level measured at 12 week follow up visit and compared between the intervention vs control arms.
Time Frame
16 weeks
Title
The difference in lipid profile as measured by mean High Density Lipoprotein - Cholesterol (HDL - C) level
Description
High density lipoprotein level measured in mg/dL at 12 week follow up visit and compared between the intervention vs control arms.
Time Frame
16 weeks
Title
Difference in smoking rates as measured by the proportion of current tobacco users
Description
The difference in proportion of participants who are current tobacco users at 12 weeks per patient report.
Time Frame
16 weeks
Title
The difference in diet as measured by Rate Your Plate score
Description
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.
Time Frame
16 weeks
Title
The difference in depressive symptoms as measured by Patient Health Questionnaire 8 (PHQ 8)
Description
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.
Time Frame
16 weeks
Title
The difference in anxiety level as measured by Generalized Anxiety Disorder 7 (GAD 7)
Description
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
Time Frame
16 weeks
Title
The difference in anxiety level as measured by Perceived Stress Scale (PSS -10)
Description
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.
Time Frame
16 weeks
Title
The difference in patient activation as measured by Patient Activation Measure 10 (PAM 10)
Description
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.
Time Frame
16 weeks
Title
The difference in Health Literacy as measured by The (e) Health Literacy Scale (eHEALS)
Description
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.
Time Frame
16 weeks
Title
The difference in safety outcomes as measured by the difference in number of patients requiring hospitalization
Description
Hospitalization as reported in electronic health records or via patient/caregiver report, verified by health records at 12 weeks follow up.
Time Frame
16 weeks
Title
The difference in safety outcomes as measured by the difference in number of patients Requiring emergency room visits
Description
Emergency room visits as reported in electronic health records or via patient/caregiver report, verified by health records at 12 weeks follow up.
Time Frame
16 weeks
Title
The difference in safety outcomes as measured by the difference in number of patients with Myocardial infarction
Description
Myocardial infarction as reported in electronic health records or via patient/caregiver report, verified by health records at 12 weeks follow up.
Time Frame
16 weeks
Title
The difference in safety outcomes as measured by the difference in number of patients with stroke
Description
Stroke as reported in electronic health records or via patient/caregiver report, verified by health records at 12 weeks follow up.
Time Frame
16 weeks
Title
The difference in safety outcomes as measured by the difference in number of patients who died
Description
Death as reported in electronic health record or via caregiver report, verified by death certificates or health records at 12 weeks follow up.
Time Frame
16 weeks
Title
The difference in cognitive function as assessed by Montreal Cognitive Assessment (MoCA)
Description
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.
Time Frame
16 weeks
Title
The difference in engagement in in-person cardiac rehabilitation sessions as measured by number of individuals completing in-person cardiac rehabilitation sessions
Description
Number of individuals completing 2, 12, 24 and 36 in person cardiac rehabilitation sessions at 12 weeks follow up.
Time Frame
16 weeks
Title
Cost of Care as assessed by a Markov Model of Cost-effectiveness
Description
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.
Time Frame
16 weeks
Title
User Engagement as assessed by total number of interactions with smartphone application
Description
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).
Time Frame
16 weeks
Title
User Engagement as assessed by overall amount of time spent using the smartphone app
Description
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).
Time Frame
16 weeks
Title
User Satisfaction as assessed by modified system usability scale
Description
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.
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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, and coronary artery angioplasty/stenting. Exclusion Criteria Non-English or non-Spanish 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lena Mathews, MD, MHS
Phone
4105500856
Email
lmathew6@jhmi.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Chang Kim, MD, PhD
Phone
4105020469
Email
ckim148@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lena Mathews, MD, MHS
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lena Mathews, MD, MHS
Phone
410-550-0856
Email
lmathew6@jh.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Impact of a Corrie Cardiac Rehabilitation Program

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