Impact of a Mobile Technology Enabled Corrie Cardiac Rehabilitation Program on Functional Status and Cardiovascular Outcomes (mTECH-Rehab): A Randomized Controlled Trial
Phase: NA
Conditions: Coronary Artery Disease, Myocardial Infarction, Myocardial Ischemia, Coronary Artery Occlusion, Coronary Artery Stenosis Stent, Bypass Graft Occlusion, Valve Heart Disease
Sponsor: Johns Hopkins University

Impact of a Corrie Cardiac Rehabilitation Program 
    
NCT05238103
10/9/2024

 
Date: 10.09.2024 
Principal Investigator: Lena Mathews, MD, MHS 
Application Number: IRB00308410 
 
 
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STUDY PROTOCOL 
 
 
Impact of a Mobile Technology Enabled Corrie Cardiac Rehabilitation Program 
on Functional Status and Cardiovascular Outcomes (mTECH REHAB): A 
Randomized Controlled Trial   
 
****************************************************************************** 
 
 
1. 
Abstract 
 
Cardiovascular disease (CVD) is the leading cause of mortality in the United States, affecting 
approximately 1 in 2 American adults.1 Evidence supports the initiation of secondary prevention 
measures for individuals with CVD soon after a CVD event.2, 3 This increases the chance of 
patient adherence to lifestyle modification and new therapies and is known as Phase I or 
inpatient cardiac rehabilitation (CR).2, 4 However, Phase I, inpatient CR is not widely 
implemented in practice.5 After hospital discharge, patients should be referred to Phase II or 
early outpatient CR, which is a comprehensive program including supervised exercise therapy, 
patient counseling, cholesterol control, blood pressure control and other key elements for 
secondary prevention of CVD.4, 6 However, there is a gap of time, usually weeks between Phase 
I CR and initiation of Phase II CR, presenting an opportunity for continued patient engagement 
via digital health technology (“Phase 1.5” CR). Following completion of Phase II CR, patients 
enter a Phase III of CR wherein physical activity/exercise is performed with less supervision and 
then to Phase IV, which is an indefinite phase of ongoing self-management wherein patients 
ideally continue with heart healthy habits. Patients who participate in CR have a lower mortality 
rate, are less likely to be readmitted to the hospital, experience fewer subsequent cardiac 
events, and have improved functional status.7-9 Despite overwhelming evidence for improved 
CVD outcomes with secondary prevention by means of CR, its implementation has historically 
been low, most notably among vulnerable populations.10 Racial/ethnic minorities, women, 
veterans, older adults, and individuals with lower socioeconomic status have the lowest CR 
participation rates among eligible patients.11, 12 
 
To address these critical gaps in the recovery process, participation in CR, and improve secondary 
prevention for patients with CVD, we developed a multilevel intervention that is based on a 
digital health strategy using the established Corrie Health platform, with funding from the 
American Heart Association. Corrie Health is a digital health intervention (DHI) that was originally 
developed at Johns Hopkins to support acute myocardial infarction recovery.13  The Corrie CV 
multilevel secondary prevention program is designed to deliver Phase I through IV CR. It includes 
a customized smartphone application (app) with real-time data analytics, supervised exercise, 
patient education, medication adherence reminders/tracking, LDL cholesterol and hemoglobin 
A1c level tracking, smartwatch integration (Apple Watch or Fitbit) for physical activity / exercise 
and heart rate tracking, wireless blood pressure monitor integration, app enabled reminders, 

 
Date: 10.09.2024 
Principal Investigator: Lena Mathews, MD, MHS 
Application Number: IRB00308410 
 
 
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health coach guided action plans to promote behavior change and clinician level intervention. 
Corrie Health delivers an accessible, early intervention from hospital to home, thereby mitigating 
the conventional barriers to secondary prevention traditionally delivered in-person, e.g., cost, 
scheduling, and transportation access.14 While smartphone ownership is increasing in White, 
Hispanic and Black individuals in the US, smartphone app use is even higher among Black 
individuals, facilitating access to lifesaving interventions for individuals who have been 
historically disadvantaged with respect to access to care.15, 16  
 
Overall, we aim to evaluate efficacy and safety of the multi-level Corrie digital health 
intervention (DHI) in a parallel arm randomized controlled trial (RCT), while ensuring the study 
protocol promotes evaluation of the DHI secondary prevention program in diverse groups of 
patients. The DHI will complement usual care, which includes in-person center-based CR, and 
will be compared to usual care alone. The primary outcome measure of the study is the 
difference in distance participants walked (i.e. functional capacity) using the 6 minute walk test 
(6MWT) at final study follow-up (12 weeks post-randomization)between the intervention and 
usual care groups. The 6MWT is a rigorously validated clinical assessment of functional 
performance in individuals with cardiovascular disease).17, 18  
 
2. Objectives  
 
Primary Outcome 
 
Difference in distance participants walked (i.e. functional capacity) between the 
intervention and usual care groups, as measured by the 6MWT at final study (12 weeks 
post-randomization) follow-up  
 
Key Secondary Outcomes (measured at 12 weeks post-randomization):  
 Composite score of secondary cardiovascular prevention metric (see Table 1) 
 LDL cholesterol level  
 CR engagement measure: The total number of CR sessions attended, whether 12 
sessions of CR sessions attended  within 90 days of a CVD event (Healthcare 
Effectiveness Data and Information Set (HEDIS) measure for patient engagement in 
cardiac rehabilitation)19 
 
Quality of Life – PROMIS Global Health Scale v1.2 20, 21 
 
In addition to the secondary outcomes outlined above, we will measure factors that may be 
relevant to heterogeneity of treatment effects and intervention’s mechanism of action, as 
follows. 
 
Health factors:  
 Systolic blood pressure and diastolic blood pressure 
 Waist circumference 
 Hip circumference 
 Body mass index (BMI) 

 
Date: 10.09.2024 
Principal Investigator: Lena Mathews, MD, MHS 
Application Number: IRB00308410 
 
 
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 Glycosylated hemoglobin (HbA1c) 
 Total cholesterol level, triglyceride level, high density lipoprotein cholesterol level, non-
HDL- cholesterol  
 Tobacco use status, quitting attempts – self-report/questionnaire 
 Diet – Rate Your Plate 22 23 
 Physical Activity - The Rapid Assessment of Physical Activity (RAPA) 
 eHealth Literacy – eHealth Literacy Scale (eHEALS)26, 27 
 
Psychosocial factors:  
 
Depressive symptoms – Patient Health Questionnaire 8 (PHQ – 8)28 
 
Anxiety – Generalized Anxiety Disorder 7 (GAD 7) 
 
Perceived stress – Perceived Stress Scale (PSS-10) 29 
 Patient activation – Patient Activation Measure 10 30 
 
Engagement in Center-Based CR Sessions: 
 Number of individuals completing 2, 12, 24 and 36 in person CR sessions (HEDIS 
measures) 
 Number of CR sessions attended per individual 
 
Safety Outcomes: 
 Hospitalization, emergency room visits, myocardial infarction, acute coronary syndrome, 
transient ischemic attack, stroke, or cardiac procedures - as reported in the EHR or via 
patient/caregiver report, verified by health records. 
 Death – as reported in EHR or via caregiver report, verified by death certificates or 
health records. 
Cost of care: 
 As assessed by a Markov Model of cost-effectiveness31 – the hospital costs (in US dollars) 
for emergency department (ED) visits and hospital readmissions will be compared between 
the intervention and usual care groups. 
 
For the intervention arm only, we will measure intervention user satisfaction and engagement: 
 User Engagement – Total number of interactions in the smartphone app and interactions 
with specific features of the smartphone app per participant, collected via the Corrie 
Health Platform User Analytics  
 User Satisfaction – System Usability Scale modified for Corrie32 
 
  
        Table 1. Composite score components of secondary cardiovascular prevention metric 
Cardiovascular Secondary Prevention Metric Components
Ideal  
Diagnosis of diabetes: HbA1c <7%  
No diagnosis of diabetes: HbA1c <5.7%  

 
Date: 10.09.2024 
Principal Investigator: Lena Mathews, MD, MHS 
Application Number: IRB00308410 
 
 
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Intermediate  Diagnosis of diabetes: HbA1c 7-7.9%  
No diagnosis of diabetes: HbA1c 5.7-6.4%  
Poor  
Diagnosis of diabetes HbA1c ≥8%  
No diagnosis of diabetes: HbA1c ≥6.5%  
Ideal  
SBP <130 and DBP <80 mmHg  
Intermediate  SBP 130-139 and DBP <90 or SBP <130 and DBP 80-89 mmHg  
Poor  
SBP ≥140 or DBP ≥90 mmHg  
Ideal  
LDL-C cholesterol <70 mg/dL  
Intermediate  LDL-C cholesterol 70 - 99 mg/dL  
Poor  
LDL-C cholesterol ≥100mg/dL  
Ideal  
BMI <25 kg/m2  
Intermediate  BMI 25-29 kg/m2  
Poor  
BMI ≥30 kg/m2  
Ideal  
≥150 min/wk moderate or ≥75 min/wk vigorous or ≥150 min/wk moderate 
and vigorous physical activities  
Intermediate  1-149 min/wk moderate or 1-74 min/wk vigorous or 1-149 
min/wk moderate and vigorous physical activities  
Poor  
None  
Ideal  
Never smoker (<100 cigarettes in lifetime)  
Intermediate  Former smoker  
Poor  
Current smoker  
Ideal Diet 
Rate Your Plate 64 - 81 
Intermediate 
Diet  
Rate Your Plate 46 - 63 
Poor Diet 
Rate Your Plate 27 - 45  
For each component ideal profile is consistent with a score of 2, intermediate profile is 
consistent with a score of 1 and poor profile with a score of 0. Subsequently a total score 
ranging from zero (worst CV Health) to 14 points (best CV health) is calculated.
 
3. 
Background  
 
The Corrie DHI program consists of a patient-facing smartphone app which provides education; 
recommendations for lifestyle modifications; medication, vitals, and exercise monitoring; 
appointment scheduling and tracking; care team directory; electronic wallet for health and 
stent cards; the ability to send PDF summary reports to clinicians; and follow-up reminders to 
optimize cardiac recovery and secondary prevention. The original version of the Corrie Health 
digital platform was tested in acute MI patients at 4 clinical sites including Johns Hopkins 
Hospital, Johns Hopkins Bayview, Reading Hospital and Massachusetts General Hospital 
(MiCORE IRB00099938).13 Patient-monitored data flows into secure servers on the backend, 
providing a source of rich, granular data over time for heart rate, steps, weight, blood pressure, 
and medication adherence. Corrie is built on Apple and Android platforms.  
 
For the present trial, the original Corrie Health digital platform was adapted to include 
extensive exercise tracking with pre-and post- exercise data capture along with weekly 

 
Date: 10.09.2024 
Principal Investigator: Lena Mathews, MD, MHS 
Application Number: IRB00308410 
 
 
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evaluations and goal setting by a trained “Corrie Coach” to promote behavior change and 
mental health support. Exercise can be performed anywhere a patient feels comfortable with, 
including neighborhood gyms or outdoors. Furthermore, patients will be provided with 
motivational messaging and feedback on progress with their goals. The Corrie Message Bank 
(attached as supplemental document) has been developed by combining validated messages 
from the mActive trial,33-35 American Heart Association’s Care Pathway messages, and patient 
generated messages. The Corrie Clinical Dashboard allows for intuitive data visualization by the 
clinician of key cardiovascular health metrics including blood pressure, heart rate, steps, 
medication adherence, exercise, and education completion. The clinician then uses this data to 
generate actionable insights and provide comprehensive feedback to the patient. The trial 
intervention has been optimized with input from demographically diverse patients, caregivers 
and clinicians (IRB00266731). A preliminary version of the intervention is being evaluated in our 
IRB approved quality improvement project (IRB00248849). Preliminary data from the quality 
improvement project supports that it is feasible to evaluate the intervention in a RCT.  
 
CR is a multi-component intervention with core components including physical activity, 
nutritional counseling, lipid management, weight management, blood pressure management, 
diabetes management, tobacco cessation, and psychological management, as outlined in 
American Heart Association’s and American Association of Cardiovascular and Pulmonary 
Rehabilitation Scientific Statement (Figure 1).36 It consists of four phases. Phase I includes early 
secondary prevention interventions, which starts immediately after cardiac 
event/surgery/intervention in the hospital setting. Phase II CR is an outpatient program with 
goals to help individuals modify their CVD risk factors and transition to independent physical 
activity, which is further intensified with less supervision during Phase III CR. Phase IV CR refers 
to ongoing self-management.4 Our study intervention has the advantage of being deployed as 
soon as a patient experiences a CVD event or undergoes cardiac surgery/procedure, thus 
empowering patients in a timely manner with knowledge regarding their new diagnosis and 
equipping them early with self-management tools.  
 
Furthermore, a home-based program can reach patients who were previously unable to 
participate in CR and promote health equity by eliminating barriers to access including 
transportation, parking, and limited working hours of CR centers. We have taken a number of 
measures in the study protocol to promote equitable participation in the trial. First, we 
optimized the intervention using inclusive, Human Centered Design Methodology where input 
from diverse groups of patients, clinicians and caregivers guided the design process. Second, we 
collaborated with the Johns Hopkins Center for Health Equity Community advisory board, 
consisting of community advocates, community leaders, community-based organization 
representatives and patients, to incorporate feedback on the study protocol and procedures. 
Third, we will cover transportation and/or parking fees for in-person CR assessment sessions in 
the intervention group. Fourth, we will provide devices, using our established “iShare” 
program,13 to participants who do not own either a smartphone or smartwatch. Fifth, we will 
offer personalized onboarding and technology assistance for patients to ensure equitable 
technology onboarding. Our study will generate evidence regarding the efficacy and safety of 

 
Date: 10.09.2024 
Principal Investigator: Lena Mathews, MD, MHS 
Application Number: IRB00308410 
 
 
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the DHI (Table 2), which could promote digitally-enabled hybrid CR uptake at scale and reduce 
the gap in lifesaving CR access and utilization.  
 
Dr. Lena Mathews, MD, MHS, PI, has extensive clinical and research experience the CR space. She 
directs the Johns Hopkins Cardiac Rehabilitation Center.  
 
Table 2. Components of DHI: The Corrie Hybrid Cardiac Rehabilitation Program 
Patient Level - Corrie App, Smartwatch, Blood pressure monitor, exercise resistance bands, 
Corrie “Coach” (attached in supplemental documents) and contextual motivational messages 
(attached in supplemental documents) 
Clinician Level – Reminder for CR referral, Reminder for ordering repeat lipid panel upon 
discharge (as recommended by professional society guidelines), In person assessment and 
two monitored and supervised sessions for personalization of home exercise, improving 
confidence and self-efficacy for home exercise, and assessment of safety of home exercise 
 
Figure 1. Core components of Cardiac Rehabilitation/Secondary Prevention Programs as per 
American Heart Association and American Association of Cardiovascular and Pulmonary 
Rehabilitation Statement.36 
 
 
 
 
 
 
 
 

 
Date: 10.09.2024 
Principal Investigator: Lena Mathews, MD, MHS 
Application Number: IRB00308410 
 
 
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4. 
Study Procedures 
 
General Overview:  
 
We will conduct a multi-site, parallel arm randomized clinical trial to evaluate the efficacy of 
the intervention plus usual care compared to usual care alone (1:1 allocation ratio) in 
individuals who present to study hospitals with the following diagnosis or interventions: ST 
elevation myocardial infarction (STEMI), Type 1 non ST elevation myocardial infarction 
(NSTEMI), Atherosclerotic Cardiovascular Disease (ASCVD) requiring coronary 
revascularization via percutaneous coronary intervention (PCI) or coronary artery bypass 
graft surgery (CABG), and valvular heart disease interventions including valvular heart 
surgery and transcatheter aortic valve replacement (TAVR). We will evaluate the primary 
outcome and secondary outcomes at 12 weeks post-randomization. Study sites include 
Johns Hopkins Hospital, Johns Hopkins Bayview Medical Center, Howard County Hospital, 
and Suburban Hospital.  
 
Enrollment, Randomization and Measurements:  
 
1. The list of patients admitted to Johns Hopkins Hospital (JHH), Johns Hopkins Bayview 
Medical Center (JHBMC), Howard County General Hospital (HCGH), and Suburban 
Hospital will be reviewed daily. We will query an electronic medical record (EHR) system 
to alert study investigators about patients admitted with any of the qualifying diagnoses 
to help with screening process. We will also query the list of the cardiac surgery 
operating room and cardiac catheterization lab to identify qualifying patients 
undergoing cardiac surgery or PCI procedure on an ambulatory basis. Furthermore, IRB 
approved flyers will be placed in clinician work rooms allowing clinicians to refer 
patients to the study. Patients who meet the inclusion criteria (see below in section 5) 
will be entered in the REDCap (Research Electronic Data Capture) database.  
2. Study team members will subsequently screen patient charts for exclusion criteria. 
Before approaching eligible patients for consent, study team members will ask the 
attending physician of the patient to obtain permission from patients for the study team 
to approach them. 
3. Patients will be approached in the hospital anytime during their index hospital 
admission or presentation for procedure.  
4. Once patients are approached, further questions will be asked to screen for exclusion 
criteria including visual, motor, and/or auditory impairment limiting digital health 
technology use.  
5. Written consent will be obtained at the bedside in the clinical units at participating sites. 
For patients who are not consent at bedside (e.g. patients undergoing same-day PCI 
procedure who have received sedation within preceding 24 hours), study team will 
follow up with a telephone call within 1 week after discharge to gauge interest in 

 
Date: 10.09.2024 
Principal Investigator: Lena Mathews, MD, MHS 
Application Number: IRB00308410 
 
 
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participation. For interested patients, informed consent will be obtained remotely via 
Docusign. 
6. Patients will be given detailed information and consent form to review during bedside 
or remote enrollment. 
7. Sufficient time will be provided to the patient to read and understand the consent form 
with a repeat of information if necessary. 
8. Patients will be given the opportunity to ask any questions to the research team while 
considering to participate in the study. 
9. Patients with hearing, motor, and visual impairment will not be included (precludes 
meaningful use of intervention technology).  
10. The study team member will share with the patient that they can take as much time as 
necessary to understand the consent form. Study team members will then ask questions 
to the patient to clarify whether they understand the information provided in the 
consent form.  
11. Once informed consent is obtained, an Epic documentation (Research note) and 
research flag will be placed in the EHR. 
12. If the patient is non-English speaking, study participation will not be available, given the 
need for extensive communication needed during CR, especially hybrid CR. 
13. After consent is obtained by the research team member and prior to randomization, 
baseline data (e.g. demographic information, relevant medical history, blood pressure, 
heart rate)) will be obtained.  
14. Following hospital discharge, consented patients will be followed up with a telephone 
call during a 4-week run-in period to assess their continued interest in study 
participation, as well as to verify their insurance approval for in-center CR. Those who 
qualify will then be randomized at a 1:1 ratio to the intervention plus usual care 
(intervention group) or usual care alone (control group). Usual care is defined as care 
according to patient care team’s standard practice. Randomization will be based on a 
dynamic randomization strategy that minimizes the difference in age, sex, and 
treatment modality (cardiac surgery, cardiac catheter-based procedure, or medical 
therapy alone). 
15. If the order for CR referral is not done automatically, we will encourage the primary 
team to place the order for CR in the EHR and/or place the CR order on behalf of the 
primary team following attending physician approval, to ensure 100% CR referral rate 
for all study participants. 
16. We will use a random number generator for generation of random number sequences 
and adopt open source software for dynamic randomization implementation. We will 
minimize bias by concealed allocation at time of enrollment. 
17. Once randomization arm is determined, a study team member will inform each patient 
of their allocation.  
18. Individuals who are randomized to the intervention who do not own a smartphone or 
smartwatch will be provided with devices. This program, called iShare, was previously 
established and successfully implemented by our study team in the MiCORE trial.13  
Participants will be allowed to keep the devices even after the study ends, if desired, to 
facilitate subsequent phases of CR and potential long-term studies in the future. If 

 
Date: 10.09.2024 
Principal Investigator: Lena Mathews, MD, MHS 
Application Number: IRB00308410 
 
 
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patients decide to leave the program during the study or within 6 months of study 
completion, they will be expected to return the devices to the study team.  
19. Individuals randomized to the intervention will receive personalized technology 
onboarding from a study team member. Depending on their level of technological 
literacy, patients will receive tailored video- and in-person guidance on how to 
download the app onto the phone, use the smartwatch [Apple Watch (FDA cleared) or 
Fitbit (FDA cleared)] and blood pressure monitor [Omron Blood pressure cuff (FDA 
cleared)] which will be paired with the smartphone via Bluetooth. The research team 
will have access to data on onboarding details as well as data collected via these 
devices, which will be reviewed during business hours on a daily basis. The participants 
will also be given a StartKit document which will include information on how to use the 
app to reference following discharge (Uploaded as supplementary document). 
Furthermore, patients will be provided with an email address and phone number to 
allow them to contact study investigators in case they have questions about technology 
use. They will also be able to submit feedback or questions regarding app use directly 
via the app. The patients will be encouraged to start using the app immediately but will 
be told to avoid unmonitored exercise until they have attended an in-person CR center 
for at least two visits, where risk stratification is performed based on AACVPR criteria 
(uploaded in Section 20.2). These two in-person sessions will serve as a basis for 
personalization of the home exercise plan, improving self-efficacy and confidence for 
home exercise, and assessment of safety for home exercise.  If patients have any high 
risk features precluding home exercise, they will not be allowed to do home exercise as 
part of study intervention but they will be able to receive coaching calls, education and 
track medication intake via the app as well as work on modification of other 
cardiovascular risk factors. Additionally, they will be encouraged to continue attending 
in-person CR sessions for safe, monitored exercise, and will be advised to perform lower 
levels of usual physical activity (e.g., walking, range of motion exercises) as advised by 
the CR staff.  
20. The initial phase of study participation in the hospital will be limited to study description 
and informed consent. All interventions will start following the 4-week run-in period, for 
those randomized to the intervention group. 
21. To promote privacy of health information, a login will be required to access the app 
(created upon onboarding). Additionally, the iPhone or Android phone will be set to 
password protected mode / face ID activated.  
22. After obtaining consent, app permissions to the Corrie smartphone app will be provided 
by the study team. In order for an app to access any data on an iOS/Android 
smartphone, the app must ask the user for permission and if and only if that permission 
is granted, the app can access that data. This is inherently enforced on all apps by the 
operating system. In our case, we only will ask for permissions to access:  
 Relevant digital health data from iOS and Android HealthKits, in particular: 
physical activity, blood pressure and heart rate. 
 Photos to store an insurance card or other cards like a stent card. Even if the 
access-permission is granted, it is limited to the images specified by the user. 

 
Date: 10.09.2024 
Principal Investigator: Lena Mathews, MD, MHS 
Application Number: IRB00308410 
 
 
Page 10 of 21 
 
 Display notifications, such as an alert to take medications. 
 Send email function to allow users to send a PDF of their consent form or a PDF 
of relevant health info (e.g., medication list, progress report) to their care 
providers. No app is allowed to read any data from the mail app. 
Participants will be given the option to take a photo in which they are identifiable using 
the app and can specify authorization for internal or external use via the standard media 
consent form. 
23. For individuals randomized to the intervention, a study team member will help patients 
locate a nearby in-person CR center, ideally a Johns Hopkins CR center. If a non-Hopkins 
center is required due to patient location, then the study team will help patients identify 
a CR center by using the American Association of Cardiovascular and Pulmonary 
Rehabilitation (AACVPR) website database of CR programs, provide a number to call, 
and assist in making the call if needed.  
24. Individuals randomized to the intervention will receive a notification on their phones to 
remind them to go to a local laboratory to have a repeat Lipid panel at 4 weeks after 
discharge from the hospital. An order for a repeat lipid panel will be placed by their 
clinical team prior to hospital discharge as it is a guideline recommendation to have a 
lipid panel rechecked to ensure adequate cholesterol control.36, 37 This component is 
part of the multi-level intervention offered to the intervention group. Patients will 
receive education on optimal lipid levels and encouragement to follow up with their 
clinician (physician or advanced care provider) to adjust their cholesterol management 
regimen if their LDL-C values are above the goal. Johns Hopkins patients will also have 
access to the Johns Hopkins Lipid clinic number through the app and if other sites are 
involved, local cardiology clinic numbers will be included. 
25. All study participants randomized to the intervention arm, prior to initiating 
unmonitored exercise at home, will attend at least two in-person CR sessions. These 
sessions will serve as a basis for personalization of the home exercise plan, improving 
self-efficacy and confidence for home exercise, and assessment of safety for home 
exercise. These two in-person sessions are part of the proposed standard of care for 
hybrid CR models for tailored approach to home-based exercise. Patients who are 
deemed high risk for exercise per AACVPR criteria4 will be encouraged to engage in the 
education, medication tracking, and behavior change components of the intervention, 
but not home exercises. They will be encouraged to continue attending in-person CR 
sessions for safe, monitored exercise, and will be advised to perform lower levels of 
usual physical activity (e.g., walking, range of motion upper body movements) as 
advised by the CR staff. Such patients will be maintained in the study for intention-to-
treat analysis.  
26. All patients will be encouraged to continue attending in-person CR sessions. Participants 
will be encouraged to attend Johns Hopkins CR centers for at least the first two sessions 
for safety evaluation, which will be assessed through electronic medical records. If a 
study participant chooses to attend an external CR center, safety assessment will occur 
by contacting the external CR staff for their assessment of how the study participant 
performed during the first two in-person CR sessions. For the intervention group only, to 

 
Date: 10.09.2024 
Principal Investigator: Lena Mathews, MD, MHS 
Application Number: IRB00308410 
 
 
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overcome the barriers of access, we will cover transportation and/or parking fees for 
participants to attend the two required in-person CR sessions using research funds.  
 
Patients will receive prescriptions for exercise from a center-based exercise physiologist 
during the in-person CR sessions. Even participants who have been randomized to the 
intervention arm will be encouraged to attend in-person CR sessions, especially at 30-
day and 60-days (beyond the first two required in-person CR sessions) to allow for 
appropriate exercise modifications to their Individualized Treatment Plans by the 
exercise physiologist. For patients who elect to not continue to attend in person CR 
sessions beyond the first two sessions, once cleared for home exercise, updated 
exercise prescriptions will be provided by the study exercise physiologist as per AACVPR 
guidelines. 
 
27. All patients randomized to the intervention will receive weekly virtual check-ins 
consisting of a video call (unless patient opts out of the video component for only audio 
call) from a trained exercise physiologist health coach, starting within 1 week from 
randomization. These virtual check-ins will be used to guide patients with individualized 
risk factor modification, stress reduction and on adapting their exercise prescription (for 
those cleared for home exercise), where the latter will be performed by a study exercise 
physiologist. If during the virtual check-in the patient reports high risk symptoms (e.g. 
chest pain), the health coach will follow Cardiac Rehabilitation Standard Operating 
Procedure scenarios (attached in supplementary documents) to handle the different 
emergencies, and they will be asked to pause the exercise component of the 
intervention until safety of returning to exercise is determined by their caring clinician. 
The Corrie Dashboard will be monitored once a day and any red flags will be handled 
similarly as per the Standard Operating Procedure. Patients will be informed that the 
study team cannot replace their care teams and patients should contact their clinicians, 
call 911 or go to emergency room when experiencing severe symptoms or abnormal 
vital signs. Virtual, synchronous, audiovisual group-based education sessions will be 
offered weekly by the exercise physiologist health coach. These sessions will 
supplement the weekly virtual check-ins for patients randomized to the intervention. 
These educational, patient-support/social networking forums aim to enhance the social 
experience of this virtual model. Social media platforms (such as Facebook group), 
moderated by the study team, may be used to facilitate voluntary communication and 
interaction among study participants for community-building purposes.  
28. At 12 weeks post-randomization follow up, all study participants will receive a survey via 
REDCap to report any adverse events, including a heart attack, repeat cardiac 
procedure, stroke, transient ischemic attack, emergency room visit, or hospital 
readmission. If a patient is readmitted to a Hopkins affiliated hospital or other site’s 
hospital, their EHR will be searched for confirmation and cause of readmission. If the 
person is readmitted to an outside hospital, we will email them an Authorization for 
Release of Health Information form asking for permission to obtain their EHR of 
readmission. If patients cannot be reached, we will contact their emergency contact to 

 
Date: 10.09.2024 
Principal Investigator: Lena Mathews, MD, MHS 
Application Number: IRB00308410 
 
 
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identify whether the patient is alive and also search the EHR. If death is reported, it will 
be verified by death certificates or through the EHR.  
29. At 12 weeks post-randomization follow up, all participants will attend an in-person 
study visit at Johns Hopkins Bayview Institute for Clinical and Translational Research 
(ICTR; Clinical Research Unit) site where all measurements outlined in Table 3 will be 
conducted, including vital signs, blood work for HbA1c and Lipid panel (non-fasting), 
body measurements, and 6MWT. If a participant cannot attend the final visit at Johns 
Hopkins Bayview ICTR site due to medical conditions, exceptions can be made to 
accommodate the participant at another study site. The 6MWT will be performed by 
ICTR staff blinded to study arm assignment to avoid bias in measurement (compared to 
the pre-discharge 6MWT for hospital-enrolled patients, which will be obtained by a 
trained study team member). Participants will be given an option to complete online 
surveys while attending the in-person study visit. If at either of these time points 
(baseline and 12 weeks post-randomization ), participants do not respond to the online 
surveys within 7 days, a member of the study team will attempt to obtain their 
responses to the surveys via a phone interview. In order to accommodate flexible 
scheduling, we will aim to allow up to 24 weeks for the final study visit. For the ICTR 
study visit, parking and transportation fees will be covered by the research study budget 
for all patients. 
30. If the study engages additional sites in the future, local participant recruitment will be 
conducted by local research team members. Site specific research team members will 
undergo training prior to site activation and thus recruitment and onboarding to the DHI 
will be conducted in consistent manner. Decisions regarding patient management will 
be made by the patient care team.  
31. For study participants in both the intervention and control groups, sociodemographic 
data as well as clinical data will be extracted from EHR (REDCap variable list is uploaded 
in section for supplementary documents).   
 
Table 3. Study Visits and Measurements  
Visit 1. Baseline visit (Data 
obtained by chart review, at the 
bedside and online surveys 
delivered via email through 
REDCap) 
Visit 2. Virtual 
visit at 4 weeks 
(for Intervention 
Arm only) 
Visit 3. 12-weeks post-randomization follow 
up visit (Data obtained at in-person visit 
and online surveys delivered via email 
through REDCap) 
In-person Measurements
In-person Measurements
Weight
Weight
Height
Height
Blood pressure
Blood pressure
Heart rate
Heart rate
Waist & Hip circumference
Waist & Hip circumference
6 min walk test 
Electronic Medical Record Review
Laboratory values and chart review
Lipid panel within 30 days of 
enrollment* 
Lipid panel 
Lipid panel*

 
Date: 10.09.2024 
Principal Investigator: Lena Mathews, MD, MHS 
Application Number: IRB00308410 
 
 
Page 13 of 21 
 
HbA1c within 3 months of 
enrollment* 
HbA1c*
Baseline clinical characteristics**
Interval clinical events**
Surveys delivered via email 
through REDCap # 
Surveys delivered via email through REDCap
# 
e-Health Literacy scale 
e-Health Literacy scale 
The Rapid Assessment of Physical 
Activity 
The Rapid Assessment of Physical Activity
Rate Your Plate
Rate Your Plate
Patient-Reported Outcomes 
Measurement Information System 
(PROMIS) Global Health Scale v1.2  
Patient-Reported Outcomes Measurement 
Information System (PROMIS) Global Health 
Scale v1.2 
Patient Activation Measure 10 30
Patient Activation Measure 10 30
Patient Health Questionnaire (PHQ-
8) ## 
Patient Health Questionnaire (PHQ-8)
Generalized Anxiety Disorder 7 
(GAD 7) 
Generalized Anxiety Disorder (GAD 7)
Perceived Stress Score  
Perceived Stress Score  
Sociodemographic survey 
(education level, income level) 
Sociodemographic survey (education level, 
income level) 
Smoking status, quitting attempts
Smoking status, quitting attempts
Electronic Medical Records and Corrie 
Health Platform User Analytics 
Number of in-person and off – site 
(asynchronous) exercise sessions 
Surveys delivered via email through REDCap
Adverse Outcome Questionnaire (myocardial 
infarction, stroke, Emergency room visit, 
hospitalization or death) 
For individuals randomized to intervention 
arm 
User Engagement - Total number of 
interactions in the smartphone app and 
feature specific interactions using the 
smartphone app per participant, collected 
via the Corrie Health Platform User Analytics 
User Satisfaction – System Usability Scale
Cost Data
The hospital costs (in US dollars) for 
emergency department (ED) visit, hospital 
readmission, and acute myocardial 
infarction (MI) will be compared between 
intervention and usual care groups. 
*If these laboratory values are not 
available patient’s care team will 
be reminded to place an order in 
EPIC as these values should be 
*Bloodwork during the follow – up visit will 
be obtained during the study visit and costs 
will be charged from the study budget.  

 
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Principal Investigator: Lena Mathews, MD, MHS 
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Page 14 of 21 
 
monitored as per cardiology society 
guideline recommendations.  
** Baseline clinical characteristics 
will record relevant details related 
to cardiovascular risk, such as 
demographics, laboratory, and 
imaging (e.g. ECG, 
echocardiography, cardiac 
catheterization) data. 
# Patients will also receive an email 
via REDCap to complete the 
following surveys:  
Patients will be advised to 
complete those surveys within 48 
hours of enrollment. The standard 
email greeting is included as a 
Supplemental Study Document. 
Survey responses will be recorded 
electronically via REDCap. All 
surveys are uploaded in 
supplementary data material 
section.  
## If PHQ-8 score is ≥10 (moderate 
or more severe depression) and 
patient is randomized to the 
intervention arm, the study 
coordinator will ask the patient to 
obtain permission from the 
patient’s primary care clinician or 
mental health clinician for home 
exercise (similar to practice for in-
person CR) prior to engaging in the 
exercise portion of the 
intervention. 
** Interval clinical events, such as adverse 
cardiovascular events, will be recorded from 
review of electronic medical records, in 
addition to the survey. 
# Patients will also receive an email via 
REDCap to complete the following surveys in 
English.  
Patients will be advised to complete those 
surveys within 48 hours of study. The 
standard email greeting is included as a 
Supplemental Study Document. Survey 
responses will be recorded electronically via 
REDCap. All surveys are uploaded in 
supplementary data material section. 
Patients will be given an option to complete 
all surveys during the study visit.  
 
Study duration and number of study visits required of research participants 
Each participant will be enrolled in the study from the time of enrollment during or shortly 
following hospitalization or cath lab encounter to 12 weeks post-randomization after 
discharge. Study visits will occur at baseline (at patient bedside or via follow up call) and 12 
weeks post-randomization post-discharge (at Bayview Clinical Research Unit, up to 
maximum 18 weeks post- (to account for delays related to clearance of procedure-related 
precautions (e.g. sternal precautions following CABG surgery) or insurance approval for 
starting in-person CR sessions), whichever occurs earlier). Patients in the intervention arm 
will also be encouraged to have a lipid panel rechecked (ordered by the primary team at 
discharge) at their local laboratory 4 weeks post-discharge. Patients in the control group will 
receive reminders from the study team to participate in the final study visit.   

 
Date: 10.09.2024 
Principal Investigator: Lena Mathews, MD, MHS 
Application Number: IRB00308410 
 
 
Page 15 of 21 
 
 
Blinding 
Although blinding participants or study team members enrolling patients is not possible, 
outcome assessors will be blinded to intervention allocation. We will instruct study 
participants not to discuss allocation with study personnel prior to both the initial and 
follow-up assessments. 
 
Definition of treatment failure or participant removal criteria 
For participants in the intervention group: If the participant stops using the Corrie DHI for 
>30 days or does not respond to phone calls after failing to complete the study surveys after 
7 days, the participant will be considered lost to follow up.  
For participants in the Control group: If the participant does not respond to phone calls 
after failing to complete the study surveys after 7 days, the participant will be considered 
lost to follow up. 
 
Description of what happens to participants receiving therapy when study ends or if a 
participant’s participation in the study ends prematurely 
When the study ends or a participant’s participation in the study ends prematurely, 
participants in the intervention group may keep their app (in which case their use will 
continue to be tracked). Any other devices that were provided during the study will be 
expected to be returned.  
Participants may be given the option to participate in future research studies. 
 
5. Inclusion/Exclusion Criteria 
 
Inclusion Criteria 
 Adult aged 18 years or older 
 Individuals presenting to the hospital for the following conditions or interventions: 
Acute myocardial infarction (STEMI or NSTEMI type 1), Coronary artery bypass grafting 
(CABG), coronary artery angioplasty/stenting (PCI), heart valve surgery, transcatheter 
aortic valve replacement (TAVR). 
 
Exclusion Criteria  
 Does not speak English  
 Physical disability that would preclude safe and adequate exercise performance 
 High risk for falls (Score >13 on Johns Hopkins Fall Risk Assessment Tool – see 
Supplemental documents) 
 Visual or hearing impairment which precludes the use of the intervention 
 Mental or behavioral impairment leading to inability to cooperate with study 
procedures 
 Clinically significant depression (uncontrolled) or history of psychosis 
 Pregnancy 
 Left ventricular ejection fraction <40% 

 
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Principal Investigator: Lena Mathews, MD, MHS 
Application Number: IRB00308410 
 
 
Page 16 of 21 
 
 Unaddressed severe valvular heart disease (e.g. severe: aortic stenosis, aortic 
regurgitation, mitral stenosis, mitral regurgitation) 
 Hypertrophic obstructive cardiomyopathy with peak resting left ventricular outflow 
gradient of >25 mmHg 
 Atrial fibrillation with uncontrolled ventricular rate (Heart rate >110 at rest) at baseline 
assessment 
 Untreated high degree atrioventricular block (ie. Mobitz II or complete heart block 
without permanent pacemaker) 
 History of cardiac arrest or sudden death 
 Presence of cardiac defibrillator 
 Uncontrolled resting arterial hypertension (Systolic blood pressure >200 mmHg or 
diastolic BP >110mmHg) at baseline assessment 
 Unrepaired aortic dissection 
 Incomplete/failed coronary revascularization procedure of culprit artery 
 Significant complications from myocardial infarction, cardiac surgery, or cardiac 
procedure including: congestive heart failure (LVEF <40%), cardiogenic shock, 
signs/symptoms of persistent post-procedure ischemia, and unaddressed post-
procedural arrhythmia or conduction complications (e.g. new left bundle branch block 
post-TAVR without pacemaker) 
 
If an eligible patient is deemed clinically unstable and unable to participate at the time of 
initial assessment, the research team member may return at a later date for reassessment. 
 
6. Drugs/ Substances/ Devices 
 
1. The Corrie app is available on both iPhone and Android platforms. In discussion with 
an FDA-consultant, because the functionality of the app is as an organizational and 
navigational tool for patients, it does not require pre-approval from the FDA before 
use with patients. It falls within the category of mobile apps for which the FDA is 
exercising enforcement discretion. 
2. The Apple Watch, Fitbit, and Omron blood pressure cuff all have received FDA 
clearance and are safe for patient use (see supplementary documents).  
 
7. Statistical Analysis 
 
The primary outcome measure of the study is the difference in distance participants walked 
(i.e. functional capacity) between the intervention and usual care groups, as measured by 
the 6MWT at final study follow-up at 12 weeks post-randomization. Based on the estimates 
from a prior RCT 41 in patients with acute coronary syndrome in a smartphone-based, 
cardiac rehabilitation program, but also accounting for a significant anticipated proportion 
of cardiac surgery and TAVR patients in our trial population, we assume a pooled standard 
deviation of 107 meters for follow-up 6MWT distance. and a minimally clinically important 
difference of 30 meters in 6MWT distance.42 

 
Date: 10.09.2024 
Principal Investigator: Lena Mathews, MD, MHS 
Application Number: IRB00308410 
 
 
Page 17 of 21 
 
 
For the trial to demonstrate noninferiority with 80% power, assuming a pooled standard 
deviation of 107 meters for the follow-up 6MWT and a true 6MWT difference in favor of the 
Corrie HCR program of 30 m, 160 patients will be required (80 per group) to exclude a 
difference of >12.5 m in favor of the usual care group. The noninferiority margin of 12.5 m 
was chosen to represent about 40% of the minimum important difference of 30 m in 
6MWT as identified in previous studies. Accounting for an attrition rate of 20% during 
follow-up after randomization, a total of 200 (100 per group) participants will be 
randomized in a 1:1 ratio to the 2 treatment arms. In order to accrue 200 patients for 
randomization, we expect to recruit up to 300 patients, until target randomization number 
has been met. We will compare the mean level of 6MWT at 12 weeks post-randomization 
between the intervention and control groups using a generalized linear regression model. 
The sample size calculation was performed using the TWOSAMPLEMEANS statement in SAS 
version 9.4 procedure PROC POWER (SAS Institute Inc., Cary, NC), in which the null value 
option was specified to represent the noninferiority margin. 
 
 
If a participant has an adverse event that results in them being discontinued from the study 
or does not engage with the intervention, that participant will be included in the intention-
to-treat analysis, which is the primary form of analysis for our study. 
 
In addition to the primary intention-to-treat analysis, a pre-specified, per-protocol analysis 
will be conducted 1) inclusive of intervention group participants who remain active in the 
study and engage with the intervention, and separately 2) among those participants (in 
both control and intervention arms) who have completed at least two in-person CR 
sessions, in order to assess the efficacy of the intervention. 
In addition, pre-specified subgroup analyses will be performed, stratified by: age, sex, 
treatment modality (cardiac surgery, catheter-based intervention, or medical therapy), and 
LDL-C level (threshold LDL-C ≥55mg/dL). 
 
8. Risks 
 
Risks include adverse events during off site/CR exercise. To minimize this risk, we have the 
following measures in place: (1) We will only enroll participants in the study who do not 
have high risk clinical characteristics for exercise based on AACVPR criteria. (2) We will ask 
patients to refrain from unmonitored exercise until they undergo further assessment for 
high risk exercise features during two in-person CR sessions and are determined to be low 
to moderate risk for exercise. If individuals are deemed high risk, they will be encouraged to 
continue attending in-person CR sessions for safe, monitored exercise, and will be advised 
to perform lower levels of usual physical activity (e.g., walking and range of motion 
exercises) as advised by the CR staff. (3) We will provide weekly check-ins with patients to 
guide them accordingly if their vitals are not within normal range or report concerning 
symptoms. The guide for these check-ins has been compiled based on the Johns Hopkins in-
person CR protocols and is attached in supplementary document section. (4) Dashboard will 

 
Date: 10.09.2024 
Principal Investigator: Lena Mathews, MD, MHS 
Application Number: IRB00308410 
 
 
Page 18 of 21 
 
be monitored once a day (during business hours). Any symptoms or red flag vitals will be 
managed as per standardized operating procedure. 
 
The 6MWT is a low-risk medical test that is performed under supervision of a trained 
exercise physiologist. Potential risks include chest pain, shortness of breath, leg cramps, 
losing balance, excessive sweating, and falling. 
 
Another risk is breach of confidentiality. The Corrie Health digital platform uses a high level 
of personal security password protection and encryption to meet privacy standards. The 
study team will disclose to the participant and IRB if a breach of confidentiality occurs. 
 
Financial risk is minimized by covering costs for transportation and parking for in-person 
visits for the intervention group using study research funds. 
 
9. Benefits 
 
Participants in the intervention group will be given access to the Corrie DHI. Through this 
intervention they may benefit from greater knowledge about their diagnosis, risk factors, 
how to modify their risk factors and develop self-efficacy to continue risk factor 
modification after completion of the program. Furthermore, they may benefit from off-
site/home based physical activity (after it is determined to be safe by in-person CR 
assessment) and develop skills that help them manage their medications as well as follow-
up appointments with their primary care provider, cardiologist, and in-person CR. Patients 
enrolled in usual care may not derive significant direct benefit, aside from knowledge 
gained during the consent process and health information gained through measurements 
taken at the final study visit. Moreover, the data that they contribute as a research 
participant could help others in the future. 
  
10. Payment and Remuneration 
 
For participants in the intervention arm, the Corrie App, Smartphone and/or smartwatch, 
Blood pressure monitor, and exercise resistance bands will be provided to participants (if 
they do not own one) at no cost to them. If a participant stops engaging with the 
intervention for at least 1 week during the study or within 6 months of study completion, 
we will ask devices to be returned to study team so that they can be recycled for use for 
other participants or future studies. All participants will be compensated via $50 e-gift cards 
at the completion of the study, after the final study visit, for which transportation and 
parking fees will be covered by the study research funds. For the intervention arm, 
transportation and parking costs associated with the two in-person CR visits will also be 
covered by the study research funds. 
 
11. Costs 
 

 
Date: 10.09.2024 
Principal Investigator: Lena Mathews, MD, MHS 
Application Number: IRB00308410 
 
 
Page 19 of 21 
 
Costs associated with smartphone and smartwatch application development, costs for 
iShare smartphone devices, blood pressure monitors, resistance bands and $50 gift cards 
have been paid through American Heart Association’s Strategically Focused Research 
Network Grant (Grant number 134503). Apple Watches for iShare program have been 
provided by Apple Inc.  
 
12. Johns Hopkins Serving as a Coordinating Center 
 
Johns Hopkins Medicine is serving as the single IRB for this study. It is the preference of 
Johns Hopkins Medicine IRB to use the SMART IRB reliance agreement as the basis of 
reliance. The SMART IRB master reliance agreement was created in 2016 to harmonize and 
streamline the IRB review process for multisite studies. It enables reliance on a study-by-
study basis, clearly defines roles and responsibilities of relying institutions and reviewing 
IRBs, and eliminates the need to sign reliance agreements for each study [e.g., a non-SMART 
IRB agreement]. 900+ institutions have already signed onto this agreement and are actively 
using it as the basis of reliance for multisite projects. Sites that will rely on JHM IRB are still 
responsible for conducting a local context review prior to the start of research at their site 
and for following any local and institutionally required policies as it applies to research at 
their site [e.g., reporting of unanticipated problems]. 
 
The JHM PI has contact information for all sites, each participating center has an active FWA 
with OHR on file. Each site will collect and manage data as described in the protocol. Sites 
will notify the coordinating center of adverse event reports and deviations via the RF3 and 
RF4 forms. Sites will complete a continuing review enrollment form that will be submitted 
at the time the parent continuing review is submitted. As part of any site conference calls, 
the coordinating center will inform sites of coordinating centers prompt reporting policy 
and will ensure they are submitted to JHM IRB per requirements. 
 
 
References:  
 
1. 
Virani SS, Alonso A, Aparicio HJ, Benjamin EJ, Bittencourt MS, Callaway CW, Carson AP, Chamberlain 
AM, Cheng S, Delling FN, Elkind MSV, Evenson KR, Ferguson JF, Gupta DK, Khan SS, Kissela BM, Knutson KL, 
Lee CD, Lewis TT, Liu J, Loop MS, Lutsey PL, Ma J, Mackey J, Martin SS, Matchar DB, Mussolino ME, 
Navaneethan SD, Perak AM, Roth GA, Samad Z, Satou GM, Schroeder EB, Shah SH, Shay CM, Stokes A, 
VanWagner LB, Wang NY, Tsao CW, American Heart Association Council on E, Prevention Statistics C and 
Stroke Statistics S. Heart Disease and Stroke Statistics-2021 Update: A Report From the American Heart 
Association. Circulation. 2021;143:e254-e743. 
2. 
Fonarow GC, Gawlinski A, Moughrabi S and Tillisch JH. Improved treatment of coronary heart disease by 
implementation of a Cardiac Hospitalization Atherosclerosis Management Program (CHAMP). Am J Cardiol. 
2001;87:819-22. 
3. 
Gruther W, Pieber K, Steiner I, Hein C, Hiesmayr JM and Paternostro-Sluga T. Can Early Rehabilitation on 
the General Ward After an Intensive Care Unit Stay Reduce Hospital Length of Stay in Survivors of Critical 
Illness?: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2017;96:607-615. 

 
Date: 10.09.2024 
Principal Investigator: Lena Mathews, MD, MHS 
Application Number: IRB00308410 
 
 
Page 20 of 21 
 
4. 
American Association of Cardiovascular & Pulmonary Rehabilitation. Guidelines for cardiac rehabilitation 
programs. Sixth edition. ed. Champaign, IL: Human Kinetics; 2021. 
5. 
Hall C, Murphy M and Scanlon A. Cardiac rehabilitation in the acute care setting: Integrative review. Aust 
Crit Care. 2017;30:99-106. 
6. 
Smith SC, Jr., Benjamin EJ, Bonow RO, Braun LT, Creager MA, Franklin BA, Gibbons RJ, Grundy SM, 
Hiratzka LF, Jones DW, Lloyd-Jones DM, Minissian M, Mosca L, Peterson ED, Sacco RL, Spertus J, Stein JH and 
Taubert KA. AHA/ACCF secondary prevention and risk reduction therapy for patients with coronary and other 
atherosclerotic vascular disease: 2011 update: a guideline from the American Heart Association and American 
College of Cardiology Foundation endorsed by the World Heart Federation and the Preventive Cardiovascular 
Nurses Association. J Am Coll Cardiol. 2011;58:2432-46. 
7. 
Lawler PR, Filion KB and Eisenberg MJ. Efficacy of exercise-based cardiac rehabilitation post-myocardial 
infarction: a systematic review and meta-analysis of randomized controlled trials. Am Heart J. 2011;162:571-584 e2. 
8. 
Dugmore LD, Tipson RJ, Phillips MH, Flint EJ, Stentiford NH, Bone MF and Littler WA. Changes in 
cardiorespiratory fitness, psychological wellbeing, quality of life, and vocational status following a 12 month cardiac 
exercise rehabilitation programme. Heart. 1999;81:359-66. 
9. 
Dunlay SM, Pack QR, Thomas RJ, Killian JM and Roger VL. Participation in cardiac rehabilitation, 
readmissions, and death after acute myocardial infarction. Am J Med. 2014;127:538-46. 
10. 
Aragam KG, Dai D, Neely ML, Bhatt DL, Roe MT, Rumsfeld JS and Gurm HS. Gaps in referral to cardiac 
rehabilitation of patients undergoing percutaneous coronary intervention in the United States. J Am Coll Cardiol. 
2015;65:2079-88. 
11. 
Beatty AL, Truong M, Schopfer DW, Shen H, Bachmann JM and Whooley MA. Geographic Variation in 
Cardiac Rehabilitation Participation in Medicare and Veterans Affairs Populations: Opportunity for Improvement. 
Circulation. 2018;137:1899-1908. 
12. 
Weingarten MN, Salz KA, Thomas RJ and Squires RW. Rates of enrollment for men and women referred 
to outpatient cardiac rehabilitation. J Cardiopulm Rehabil Prev. 2011;31:217-22. 
13. 
Marvel FA, Spaulding EM, Lee MA, Yang WE, Demo R, Ding J, Wang J, Xun H, Shah LM, Weng D, 
Carter J, Majmudar M, Elgin E, Sheidy J, McLin R, Flowers J, Vilarino V, Lumelsky DN, Bhardwaj V, Padula WV, 
Shan R, Huynh PP, Wongvibulsin S, Leung C, Allen JK and Martin SS. Digital Health Intervention in Acute 
Myocardial Infarction. Circ Cardiovasc Qual Outcomes. 2021;14:e007741. 
14. 
McCarthy MM, Vaughan Dickson V and Chyun D. Barriers to cardiac rehabilitation in women with 
cardiovascular disease: an integrative review. J Cardiovasc Nurs. 2011;26:E1-E10. 
15. 
Mobile Fact Sheet.https://www.pewresearch.org/internet/fact-sheet/mobile/. Last accessed 2.20.2022. 
16. 
Anderson M. Racial and ethnic differences in how people use mobile technology. 2015. 
17. 
Enright PL. The six-minute walk test. Respir Care. 2003;48:783-5. 
18. 
Solway S, Brooks D, Lacasse Y and Thomas S. A qualitative systematic overview of the measurement 
properties of functional walk tests used in the cardiorespiratory domain. Chest. 2001;119:256-70. 
19. 
Healthcare Effectiveness Data and Information Set Measures https://blog.ncqa.org/cardiac-rehabilitation-a-
new-hedis-measure-for-heart-health/. 
20. 
Eton DT, Beebe TJ, Hagen PT, Halyard MY, Montori VM, Naessens JM, Sloan JA, Thompson CA and 
Wood DL. Harmonizing and consolidating the measurement of patient-reported information at health care 
institutions: a position statement of the Mayo Clinic. Patient Relat Outcome Meas. 2014;5:7-15. 
21. 
Hays RD, Bjorner JB, Revicki DA, Spritzer KL and Cella D. Development of physical and mental health 
summary scores from the patient-reported outcomes measurement information system (PROMIS) global items. Qual 
Life Res. 2009;18:873-80. 
22. 
Kim M. Gans PhD M, LDN,Mary Lynne Hixson MA, RD,Charles B. Eaton MD, MS,Thomas M. Lasater 
PhD. Rate Your Plate: A Dietary Assessment and Educational Tool for Blood Cholesterol Control. Nutrition in 
Clinical Care. 2000;Volume3:Pages 163-169. 
23. 
Rate Your Plate https://www.brown.edu/academics/public-health/chphe/sites/public-health-
cher/files/Rate%20Your%20Plate.pdf. 
26. 
Norman CD and Skinner HA. eHealth Literacy: Essential Skills for Consumer Health in a Networked 
World. J Med Internet Res. 2006;8:e9. 
27. 
Norman CD and Skinner HA. eHEALS: The eHealth Literacy Scale. J Med Internet Res. 2006;8:e27. 
28. 
Strine TW, Dhingra SS, Kroenke K, Qayad M, Ribble JL, Okoro CA, Balluz LS, Dube SR, Lando J and 
Mokdad AH. Metropolitan and micropolitan statistical area estimates of depression and anxiety using the Patient 
Health Questionnaire-8 in the 2006 Behavioral Risk Factor Surveillance System. Int J Public Health. 2009;54:117-
24. 

 
Date: 10.09.2024 
Principal Investigator: Lena Mathews, MD, MHS 
Application Number: IRB00308410 
 
 
Page 21 of 21 
 
29. 
Cohen S, Kamarck T and Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 
1983;24:385-96. 
30. 
Hibbard JH, Mahoney ER, Stockard J and Tusler M. Development and testing of a short form of the patient 
activation measure. Health Serv Res. 2005;40:1918-30. 
31. 
Briggs A and Sculpher M. An introduction to Markov modelling for economic evaluation. 
Pharmacoeconomics. 1998;13:397-409. 
32. 
Bangor A KP, Miller JT. An empirical evaluation of the system usability scale. Int J Hum Comput Interact. 
2008;24:574–594. 
33. 
Martin SS, Feldman DI, Blumenthal RS, Jones SR, Post WS, McKibben RA, Michos ED, Ndumele CE, 
Ratchford EV, Coresh J and Blaha MJ. mActive: A Randomized Clinical Trial of an Automated mHealth 
Intervention for Physical Activity Promotion. J Am Heart Assoc. 2015;4. 
34. 
Silverman-Lloyd LG, Kianoush S, Blaha MJ, Sabina AB, Graham GN and Martin SS. mActive-Smoke: A 
Prospective Observational Study Using Mobile Health Tools to Assess the Association of Physical Activity With 
Smoking Urges. JMIR Mhealth Uhealth. 2018;6:e121. 
35. 
Shan R, Yanek LR, Silverman-Lloyd LG, Kianoush S, Blaha MJ, German CA, Graham GN and Martin SS. 
Using Mobile Health Tools to Assess Physical Activity Guideline Adherence and Smoking Urges: Secondary 
Analysis of mActive-Smoke. JMIR Cardio. 2020;4:e14963. 
36. 
Balady GJ, Williams MA, Ades PA, Bittner V, Comoss P, Foody JM, Franklin B, Sanderson B, Southard 
D, American Heart Association Exercise CR, Prevention Committee tCoCC, American Heart Association Council 
on Cardiovascular N, American Heart Association Council on E, Prevention, American Heart Association Council 
on Nutrition PA, Metabolism, American Association of C and Pulmonary R. Core components of cardiac 
rehabilitation/secondary prevention programs: 2007 update: a scientific statement from the American Heart 
Association Exercise, Cardiac Rehabilitation, and Prevention Committee, the Council on Clinical Cardiology; the 
Councils on Cardiovascular Nursing, Epidemiology and Prevention, and Nutrition, Physical Activity, and 
Metabolism; and the American Association of Cardiovascular and Pulmonary Rehabilitation. Circulation. 
2007;115:2675-82. 
37. 
Grundy SM, Stone NJ, Bailey AL, Beam C, Birtcher KK, Blumenthal RS, Braun LT, de Ferranti S, Faiella-
Tommasino J, Forman DE, Goldberg R, Heidenreich PA, Hlatky MA, Jones DW, Lloyd-Jones D, Lopez-Pajares N, 
Ndumele CE, Orringer CE, Peralta CA, Saseen JJ, Smith SC, Jr., Sperling L, Virani SS and Yeboah J. 2018 
AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of 
Blood Cholesterol: A Report of the American College of Cardiology/American Heart Association Task Force on 
Clinical Practice Guidelines. Circulation. 2019;139:e1082-e1143. 
41. 
Yudi MB, Clark DJ, Tsang D, Jelinek M, Kalten K, Joshi SB, Phan K, Ramchand J, Nasis A, Amerena J, 
Koshy AN, Murphy AC, Arunothayaraj S, Si S, Reid CM and Farouque O. SMARTphone-based, early cardiac 
REHABilitation in patients with acute coronary syndromes: a randomized controlled trial. Coron Artery Dis. 
2021;32:432-440. 
42. 
Gremeaux V, Troisgros O, Benaim S, Hannequin A, Laurent Y, Casillas JM and Benaim C. Determining 
the minimal clinically important difference for the six-minute walk test and the 200-meter fast-walk test during 
cardiac rehabilitation program in coronary artery disease patients after acute coronary syndrome. Arch Phys Med 
Rehabil. 2011;92:611-9.