Patient Centered Mobile Health Technology Enabled Atrial Fibrillation Management: A Pilot Randomized Clinical Trial
Phase: NA
Conditions: Atrial Fibrillation, Behavior
Sponsor: Johns Hopkins University

Patient Centered Mobile Health Technology 
Enabled Atrial Fibrillation Management
NCT05400837
8/25/2023

 
Date:  8.25.2023 
Principal Investigator: David Spragg, MD 
Application Number: IRB00321575 
 
 
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JHM IRB - eForm A – Protocol 
 
 
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Use the section headings to write the JHM IRB eForm A, inserting the appropriate material in 
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When submitting JHM IRB eForm A (new or revised), enter the date submitted to the field at 
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Patient Centered mobile health TECHnology Enabled Atrial Fibrillation Management (mTECH Afib): A 
Pilot Randomized Clinical Trial  
 
1. 
Abstract 
a. Provide no more than a one page research abstract briefly stating the problem, the research 
hypothesis, and the importance of the research. 
 
Atrial fibrillation (Afib) is the most common arrhythmia.1 Lifetime risk of Afib is one in five to one in three 
individuals.2 Increased overall time spent in Afib (Afib burden) and recurrent AF episodes have been 
associated with higher risk of heart failure, stroke, poor quality of life, and mortality. 3 Early 
implementation of strategies to maintain sinus rhythm reduces cardiovascular mortality, stroke or 
hospitalization for heart failure or acute coronary syndrome and improves quality of life.4, 5 Efficacy of 
these interventions can be limited in the setting of uncontrolled Afib risk factors. Modifiable Afib risk 
factors include sleep apnea, hypertension, obesity, physical inactivity, inadequate cholesterol and 
glycemic control, smoking, and alcohol use.6, 7 Both observational and randomized studies have 
demonstrated significant reduction in Afib burden and recurrent Afib episodes with aggressive risk factor 
modification intervention programs delivered in-person among patients with Afib.8-11 Risk factor 
modification is now recommended by American Heart Association and American College of Cardiology 
Afib Guidelines.7 Such interventions are not widely implemented, due to its association with high costs 
and the need for trained personnel, which deprives numerous patients from this evidence-based care. 
Furthermore, evidence suggests poor translation of guidelines in patient care for other core aspects of AF 
care, including stroke prevention and rhythm control, especially among underserved minorities.3, 12 
Additionally, patients with Afib have poor quality of life13 and report poor communication and guidance 
while experiencing AF episodes (IRB00230621). Mobile health technologies, including smartphone 
applications (“apps”) and wearable devices have tremendous potential to bridge this gap and enable 
delivery of risk factor modification programs to patients with Afib at scale. By digitizing the processes and 
system of Afib management program, we will be able to increase access to guideline directed Afib care at 
scale and ultimately improve the quality of the service we provide to our patients as well as improve 
health outcomes.  
             We co-designed the Corrie Virtual Atrial Fibrillation Management Program “Corrie VCare Afib” on 
the platform of Corrie Health in an inclusive manner together with patients, their health partners and 
clinicians in a way that meets their needs (IRB00230621). This comprehensive and multi-component 
program aims to empower patients to a) take an active role in learning about Afib management options, 
starting and adhering to evidence-based therapies b) help build new healthy habits for risk factor 

 
Date:  8.25.2023 
Principal Investigator: David Spragg, MD 
Application Number: IRB00321575 
 
 
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modification c) guide them during Afib episodes which are associated with anxiety and impairment in 
quality of life and d) provide peer support for emotional health.  
 
We aim to 1) evaluate the Corrie VCare Afib intervention in a pilot randomized clinical trial of 100 
patients to inform feasibility - recruitment and retention rates of study participants, evaluate effect size, 
feasibility and acceptability of the intervention and study measurement procedures. Findings from this 
pilot phase will provide critical information to inform evaluation of the intervention in a larger 
randomized clinical trial powered for health outcomes, including measures to mitigate attrition rates 2)  
estimate the prevalence of Afib risk factors 3)  characterize sleep symptoms and cardiovascular stress, as 
one of the core risk factors for Afib, sleep apnea is under characterized specifically in this population.   
        
2. 
Objectives (include all primary and secondary objectives) 
 
The primary objective of this pilot study is to inform the feasibility of conducting the study:   
 
Primary outcome: Retention rates at 3 months (number of individuals who continue study participation 
(defined by App interaction, Coaching call participation or follow up survey completion) divided by the 
number of individuals who consent to participation in the study at 3 months after enrollment. 
Retention rates of at least 60% at 3 month will be considered acceptable. 
(https://www.cvdigitalhealthjournal.com/article/S2666-6936(22)00002-0/fulltext#figures)  
 
As part of feasibility objective will also evaluate: 
a) screen failure rates (number of individuals who are eligible for enrollment divided by number of 
individuals screened (meeting inclusion criteria), 
b) recruitment rates (number of individuals who are eligible for participation in study divided by the 
number of individuals who provide consent to participate in the study) as well as number of individuals 
who are enrolled in a study per month,  
 
The secondary objective of the study is to evaluate feasibility of implementing study procedures, 
measurement tools and collecting study data. We will evaluate secondary objectives by examining:  
 
a) Completion rates for study interventions (e.g. survey completion rates, coaching call completion rates 
b) App engagement (Total number of interactions in the smartphone app and overall amount of time 
spent using the smartphone app per participant, collected via the Corrie Health Platform User Analytics), 
rhythm check log rates, vital sign log rate)  
c) User satisfaction – System Usability Scale modified for Corrie Afib 
 
We will conduct exploratory analysis of the results of the following effectiveness measurements as well 
as metrics that may be relevant to heterogeneity of treatment effects and intervention’s mechanism of 
action:  
 
❑ Quality of Life - measured by Atrial Fibrillation Effect on Quality‐of‐Life (AFEQT), validated 
disease specific measure which consists of 20 items. Score ranges from 0 to 100 with higher 
scores signifying better quality of life. 14Error! Hyperlink reference not valid.At least 5 point 
change in AFEQT score is considered clinically meaningful.15 

 
Date:  8.25.2023 
Principal Investigator: David Spragg, MD 
Application Number: IRB00321575 
 
 
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❑ Atrial Fibrillation episode burden, symptom burden and healthcare utilization – measured by the 
Atrial Fibrillation Severity Scale (AFSS) – validated 19 item questionnaire.16  
❑ Berlin Sleep Questionnaire- 10 item questionnaire assessing sleep apnea risk through 3 different 
categories, and classifies patients as high or low risk.17 
❑ Brief Sleep Characterization – Team designed Afib specific questions to characterize sleep apnea 
in patients with atrial fibrillation 
❑ Social Support – measured by Medical Outcomes Social Support Survey Instrument (MOS Social 
Support Scale) -  Is a 19 item questionnaire with final score ranging between 0 – 100 with higher 
scores suggesting more support 18Error! Hyperlink reference not valid.  
❑ Skills in applying electronic health information to health problems– measured by 8-item 
questionnaire eHealth Literacy Scale (eHEALS) 19, 20  
❑ Depressive symptoms – Patient Health Questionnaire 8 (PHQ – 8) - 8‐item measure with  (≤4: no 
depressive symptom, 5–9: mild, ≥10: moderate to severe depressive symptoms)21 
❑ Generalized Anxiety Disorder 7 (GAD 7) – score ranges from 0 to 21 with higher scores indicating 
more anxiety 22  
❑ Perceived Stress Score (PSS-10). In this 10 item questionnaire score ranges from 0-40 with higher 
scores indicating higher level of anxiety.23 
❑ AF Episode Burden as assessed by the ratio of 30 second single lead ECG recordings (via Apple 
Watch) reporting Afib divided by total number of 30 second single lead ECG recordings  
❑ Physical Activity – As assessed by The Rapid Assessment of Physical Activity (RAPA)24  
❑ Diagnosis of Sleep Apnea, Continuous positive airway pressure (CPAP) therapy  
❑ Alcohol use – as assessed by The Alcohol Use Disorders Identification Test (AUDIT), 10-item 
questionnaire. The score range is from 0 to 40 with 0 referring to abstainer with no history of 
alcohol abuse and higher scores indicate gradually higher and hazardous alcohol dependence. 25, 
26 
❑ Smoking status – as assessed by study team developed questionnaire responses and evaluating 
the ratio of participants who report quitting smoking at 12 week f/u divided by number of 
participants who report smoking at baseline  
❑ Diet – Rate Your Plate. 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.27, 28 
❑ Blood pressure Attainment of BP less than 130/80 mmHg, averaged over two measurements per 
time point29 
❑ Body Mass Index  
 
 
Safety Outcomes: 
❑ Hospitalization, Emergency room visits, myocardial infarction, Stroke - as reported in electronic 
health records or via patient/caregiver report, verified by health records. 
❑ Death – as reported in electronic health records or via caregiver report, verified by death 
certificates or health records 
 
To further characterize sleep apnea patterns and assess validity of Afib specific sleep apnea questionnaire 
we aim to conduct one time home sleep apnea testing (FDA approved Itamar WatchPAT device) in 

 
Date:  8.25.2023 
Principal Investigator: David Spragg, MD 
Application Number: IRB00321575 
 
 
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patients enrolled in usual care arm after they complete 12 week follow up assessments. WatchPAT 
devices will be mailed to patients home address and results of the study will be shared with patients and 
their cardiologist/care team.  
 
3. 
Background (briefly describe pre-clinical and clinical data, current experience with procedures, 
drug or device, and any other relevant information to justify the research) 
 
Our study team has conducted inclusive design sessions (Human Centered Design Sessions) in 
collaboration with Johns Hopkins Center for Health Equity with support from American Heart Association 
to identify challenges that diverse group of patients and their health partners with Afib face in everyday 
life and similarly challenges that clinicians face while managing Afib (IRB00230621). Guidance with 
evidence based Afib care, peer support, Afib episode management and risk factor modification were 
identified as top problems patients and clinicians wish to be addressed via digital toolkit. These 
challenges are in line with well established gaps in care suggested in literature.  
 
In order to bridge the gap in Afib care and provide access to guideline recommended Afib management 
to patients, we have designed virtual Afib care model “Corrie VCare Afib” on Corrie Health platform. 
Program leverages digital health technologies, namely Corrie Health patient facing app, Clinician 
Dashboard, FDA approved wearable devices providing data generation (Apple Watch, Bluetooth enabled 
blood pressure cuffs (Omron) and Itamar Watch PAT home sleep apnea testing. The role of the industry 
collaborators is hardware and software donation and advice on technology best practices. There is no 
expectation for data sharing. 
 
The app, Corrie, is the same platform used in IRB00099938, QI project (IRB00148849), Human Centered 
Design Studies (IRB00266731 and IRB 00230621). App owners will have access to limited PII and PHI 
(name and email). Core app functions include: 1) medication tracking; 2) CPAP use tracking via patient 
logs 3) vital signs and heart rhythm and physical activity tracking; 4) patient education; 5) summary 
report for care team; 6) assistance in organization of care, 7) connecting with care team and Johns 
Hopkins nurse-led patient coaching 8) access to already established social media patient led support 
groups.  
 
Furthermore, one of the core risk factors for atrial fibrillation is sleep apnea. Sleep is an essential period 
for cardiovascular system as during this time heart rate and blood pressure are reduced allowing 
restoration and recovery of cardiovascular system.30 In patients with sleep disorders, such as sleep apnea 
however, sleep is a significant source of cardiovascular stresses related to periods of hypoxemia, changes 
in intrathoracic pressure and surges of sympathetic activity during arousals.31 However true prevalence 
and characterization of sleep apnea is lacking in patients with atrial fibrillation. By deploying sleep 
assessment to all patients enrolled in the trial (at baseline for individuals in intervention arm and at 
follow up in control group) as well as deploying sleep characterization questionnaires we will be able to 
bridge this gap and characterize sleep among patients with sleep apnea (detailed sleep apnea testing and 
treatment plan is uploaded in Section 20.2 as part of Corrie VCR program document.  
 
 
 
4. 
Study Procedures 
a. Study design, including the sequence and timing of study procedures   
(distinguish research procedures from those that are part of routine care). 
 

 
Date:  8.25.2023 
Principal Investigator: David Spragg, MD 
Application Number: IRB00321575 
 
 
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General Overview: 
 
We will conduct a pilot, parallel arm randomized clinical trial in a convenience sample of 100 patients 
with paroxysmal atrial fibrillation (diagnosed not more than 12 months prior to randomization) who 
presents for evaluation (Afib at Johns Hopkins Outpatient Cardiology Clinic, Johns Hopkins Bayview 
cardiology or electrophysiology clinics, or Medical Pavilion at Howard County electrophysiology clinic). 
We will evaluate feasibility and preliminary efficacy of multi-component Corrie VCare AF Program in 
addition to usual care vs usual care alone.  
Given proven benefits on cardiovascular outcomes with 12-week rehabilitation programs for patients 
with range of other cardiovascular diseases we will deploy digital AF program for 12 weeks.  
 
Table 1.  
Components of Corrie VCare Afib Program  Multi Component Intervention  
Corrie Afib App, Apple Watch, Itamar WatchPAT Home Sleep Apnea Test, BP cuff, scale, Nurse-coach 
for Corrie Afib (guidance document uploaded in Section 20.2) and contextual motivational messages 
(document uploaded in Section 20.2), voluntary access to public patient led Facebook AF support 
group (https://www.facebook.com/groups/AtrialFibrillationSupportForum)  
 
 
Enrollment, Randomization and Measurements: 
 
1. The list of patients in the cardiology and electrophysiology outpatient clinics at Johns Hopkins 
Hospital (JHH), Johns Hopkins Bayview Medical Center (JHBMC), and Medical Pavilion at Howard 
County (MPHC) will be reviewed daily by study team member. Furthermore, flyers will be placed 
at JHH and JHBMC cardiology outpatient clinician work rooms to increase visibility of the study 
and allow clinicians to refer patients to the study. Patients who meet the inclusion criteria (see 
below in section 5) will be entered into REDCap (Research Electronic Data Capture) dataset.  
2. Study team members will subsequently screen patient charts for exclusion criteria.  
3. Before approaching eligible patients for consent, study team members will ask the attending 
physician of the patient to obtain permission from patients for study team to approach them. 
Study team members will also assess whether treating clinicians deem Corrie VCare Afib program 
safe for patients 
4. Patients will be approached in the outpatient clinic either before or after their scheduled clinic 
visit. 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 
(precludes meaningful use of intervention technology). 
5. Research team member will provide patients with detailed information and consent form to 
review prior to starting further discussion.  
6. Confirmation about having as much time as necessary will be done by allowing the patient to 
read the consent form with unlimited time and a repeat of information 
7. Patients will be given the opportunity to ask any questions of research team before considering 
consenting to participate in study. 
8. After consent is obtained, patients will be randomized at a 1:1 ratio, stratified by location of 
enrollment (JHH vs JHBMC vs MPHC) and practice (Cardiology vs Electrophysiology) to the VCare 
Afib program along with usual care or usual care alone. Usual care is defined by care delivered by 
patients clinical team.  

 
Date:  8.25.2023 
Principal Investigator: David Spragg, MD 
Application Number: IRB00321575 
 
 
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9. We will use a web-based tool for randomization using variable-sized blocks (2-6). We will 
minimize bias by concealed allocation. 
10. Once randomization arm is determined, a study team member will inform each patient of their 
allocation.  
 
11. Individuals randomized to the Corrie Afib Virtual Program will receive onboarding from a study 
team member.  Patients will receive step by step guidance on how to download the Corrie Afib 
app onto the phone, use Apple Watch device, blood pressure cuff [Omron Blood pressure cuff 
(FDA cleared)], which will be paired with the smartphone via Bluetooth and scale. They will also 
be instructed on the use of one-time Itamar Watch PAT home sleep apnea testing (Detailed 
description of sleep apnea testing and treatment is uploaded in Section 20.2 as part of the Corrie 
VCare Afib Program description document). We will ask patients to keep WatchPAT on for the 
entire night. For a study to be considered acceptable, we will require a minimum recording 
duration of 4 hours, which is standard of care. If a recording does not meet minimum duration 
requirement, then the participant would be asked to repeat the sleep study. Patients will be able 
to keep Apple Watch, BP cuffs and scale after the study if they will plan to use the equipment, 
otherwise they will be provided with return mailers for Apple Watch device. The research team 
will have access to data collected via these devices and will review them on a weekly basis. 
Patients will be provided with an email 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. Patients will be encouraged to start using the app 
immediately; they will be able to receive education and log medication use and CPAP wearing 
time via the app as soon as the app is downloaded. Patients will be instructed to record single 
lead (Apple watch) ECG twice a day and when they experience symptoms concerning for Afib.  
12. To promote privacy of health information, a login will be required to access the app (created 
upon onboarding). Additionally, the iPhone will be set to password protected mode / face ID 
activated.  
13. After obtaining consent, app permissions will be given. In order for an app to access any 
information on an iOS smartphone, the app must ask the user for permission and only if that 
permission is granted, can the app access that information. 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 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. 
• 
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. 
14. All patients in the Corrie VCare Afib program will receive weekly check-in calls from Johns 
Hopkins Cardiology Nurse (Stephney Blair or Courtney Eddy) – Corrie Afib coach to guide patients 
with individualized risk factor modification. If during conversation with the Corrie Afib health 
coach patients report concerning symptoms, including chest pain, shortness of breath and more, 
the health coaches will follow study Standard Operating Procedure Protocol to handle the 
different scenarios (attached in supplementary documents in Section 20.2 Patients will be 
informed that the Corrie Afib  team cannot replace their care teams and patients should contact 

 
Date:  8.25.2023 
Principal Investigator: David Spragg, MD 
Application Number: IRB00321575 
 
 
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their clinicians, call 911 or go to emergency room when experiencing symptoms or abnormal vital 
signs. 
15. Patients in the Corrie VCare AF program will also receive messages tailored to their risk factor to 
facilitate lifestyle modification. Text messages which will be sent as push notifications via an app. 
Corrie Message Bank has been developed by combining validated messages from mACTIVE trial, 
American Heart Association’s Care Pathway messages and patient generated messages. 
(Attached as supplemental document in Section 20.2). There are slight modifications in the 
message bank for Afib version compared to cardiac rehabilitation version approved by the IRB 
(IRB00308410) with addition of sleep apnea messages and modified physical activity messages. 
Patient specific risk factors will be reviewed by the chart review and confirmed with patients. 
Then based on patients’ goals for each risk factor messages promoting building healthy habits for 
patient preferred risk factor will be sent to them with patient desired frequency.  
16. Through the app patients in Corrie VCare AF program will be able to record ECG (using Apple 
Watch device), log CPAP wear times, record their vital signs, symptoms and perceived triggers. 
They will be able to alert their clinician via app and receive guidance for episode management. 
They will also be able to alert health partner (pre-specified in the app) that they are experiencing 
Afib episode. App will alert patients that if they are experiencing medical emergency, they should 
call 911.  
17. At 12 weeks follow up, all study participants will receive a survey via REDCap to report any 
adverse events  -  stroke, emergency room visit, heart attack or hospital readmission. If a patient 
is readmitted to a Hopkins affiliated hospital their record 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 
records of readmission. If patients cannot be reached, we will contact their emergency contact to 
identify whether the patient is alive and also search electronic health records, if death is reported 
it will be verified by death certificates or health records.  
18. Study measurements and their timing is summarized in Table 2. Detailed list of data elements 
collected is uploaded in Section 20.2  
 
Table 2. Study visits and variables obtained (comprehensive list of variables uploaded in Section 20.2) 
 
Visit 1. Baseline visit  
Virtual Visit at 3 months 
From Chart (day of enrollment) 
 
sex 
 
age 
 
race/ethnicity 
 
insurance type 
 
contact information (email, phone) 
 
Enrollment location 
 
smartphone ownership 
 
height 
 
hypertension 
 
diabetes 
 
dyslipidemia 
 
left ventricular ejection fraction (latest within 6 months) 
 
aortic dissection 
 
icd 
 

 
Date:  8.25.2023 
Principal Investigator: David Spragg, MD 
Application Number: IRB00321575 
 
 
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cardiac surgery within 12 months 
 
hypertrophic cardiomyopathy with >25mmHg resting 
gradient 
 
cardiac arrest or ventricular arrhythmia 
 
Untreated high grade atrioventricular block 
 
Severe valvular disease (any) 
 
Mitral stenosis 
 
Presence of artificial heart valve or valve repair 
 
Coronary artery disease 
 
Congestive heart failure 
 
Atrial fibrillation type 
 
TIA/stroke  
 
CHADSVASC Score 
 
Vascular disease 
 
Sleep Apnea 
 
Incomplete revascularization of coronary artery disease 
 
pregnancy 
 
Implanted cardiac device 
 
Cholesterol panel (within 6 month of enrollment)* 
Cholesterol panel (within 1 month of 
follow up)* 
Hb A1c (within 6 month of enrollment)* 
Hb A1c (within 1 month of follow up)* 
Determined upon enrollment   
 
iPhone ownership 
 
Apple watch ownership 
 
Access to wifi 
 
Health Metrics  
 
Weight 
Weight** 
Blood Pressure 
Blood Pressure** 
From Corrie Health Analytic Platform & Devices (for 
individuals in Corrie VCare Afib Program) 
 
Heart rate 
Heart rate 
Average Weekly Step Count  
Average Weekly Step Count 
 
User Engagement - Total number of 
interactions in the smartphone app and 
overall amount of time spent using the 
smartphone app per participant, collected 
via the Corrie Health Platform User 
Analytics 
 
Rhythm Check Proportion 
 
BP check proportion 
 
HR check proportion 
 
Medication log proportion 
 
Exercise log proportion 
 
Proportion of AF Episodes 
 
Number of times called nurse team 
 
Number of nurse coaching completed 

 
Date:  8.25.2023 
Principal Investigator: David Spragg, MD 
Application Number: IRB00321575 
 
 
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Symptom/AF episode concordance 
 
Identified AF trigger (self-report) 
 
User Satisfaction – System Usability Scale 
(Modified for Corrie Afib) 
Surveys delivered via email through REDCap*** 
 
e-Health Literacy scale  
e-Health Literacy scale 
AFEQT 
AFEQT 
AFSS 
AFSS 
Medical Outcomes Social Support Survey Instrument 
(MOS Social Support Scale) 
 
Rate Your Plate 
Rate Your Plate 
Rapid Assessment of Physical Activity 
Rapid Assessment of Physical Activity 
minutes of exercise per week and perceived exertion 
score combination 
minutes of exercise per week and 
perceived exertion score combination 
Patient Health Questionnaire (PHQ-8)*** 
Patient Health Questionnaire (PHQ-8) 
Generalized Anxiety Disorder 7 (GAD 7) 
Generalized Anxiety Disorder (GAD 7) 
Perceived Stress Score -10 
Perceived Stress Score -10 
Sociodemographic survey (education level, income level) 
 
Smoking Status 
Smoking Status, quitting attempts 
Alcohol use status, AUDIT questionnaire 
 
Alcohol use status, AUDIT questionnaire 
 
Sleep Apnea diagnosis, CPAP use 
Sleep Apnea diagnosis, CPAP use 
Sleep Characterization tailored for Afib patients  
 
Berlin Questionnaire (sleep apnea screening) 
 
 
Adverse Outcome Survey  
** 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.  
 
 
The hospital costs (in US dollars) for 
emergency department (ED) visit, hospital 
readmission, and acute myocardial 
infarction (MI) will be compared between 
Corrie Virtual Afib Program and usual care 
groups. 
*If available  
** Blood pressure cuff and scale will be mailed to patients at 12 weeks to obtain self-assessment at 
12 weeks 
*** If PHQ 8 score is  ≥10 and patient is randomized to Corrie VCare Afib program, study team member will 
ask patient to obtain permission from patients primary care clinician to exercise at home and won’t be allowed to 
engage in exercise portion of the intervention until patient confirms permission from the treating clinician.” 
 
 
 

 
Date:  8.25.2023 
Principal Investigator: David Spragg, MD 
Application Number: IRB00321575 
 
 
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b. If your study involves data/biospecimens from participants enrolled under other research studies 
with a written consent or under a waiver of consent, please list the IRB application numbers for 
those studies.  Please note:  Certificate of Confidentiality (CoC) protections applied to the data in 
source studies funded by NIH or CDC will extend to this new study if the funding was active in 
2016.  If this situation applies, Section 36, question 6 in the application will need to be answered 
“Yes” and “Hopkins Faculty” should be selected in question 7. No other documents are required. 
 
      N/A 
 
c. Study duration and number of study visits required of research participants. 
 
Each participant will be enrolled in the study from the time of enrollment for 12 weeks. Study visits 
will occur at baseline only, 3 months follow up visits will be virtual limited to data collection remotely 
as above (Table 2). 
 
d. Blinding, including justification for blinding or not blinding the trial, if applicable. 
 
Although blinding participants or study team members enrolling patients is not possible, outcome 
assessors will be blinded to intervention allocation.  
 
 
e. Justification of why participants will not receive routine care or will have current therapy 
stopped. 
 
All participants will continue to receive usual care. 
 
 
f. Justification for inclusion of a placebo or non-treatment group. 
 
All participants will continue to receive usual care.  
 
g. Definition of treatment failure or participant removal criteria. 
 
For participants with Corrie VCare Afib program: If an individual stops using platform for >30 days or 
does not respond to phone calls from study team or after failing to complete the study surveys after 
7 days without response to phone calls 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. 
 
 
h. 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 Corrie VCare AFib program who have received loaned smartphone will be expected to return the 
device, if they chose to continue using devices they will be allowed to keep the rest of the study 
equipment. Otherwise we will ask patients to return Apple Watch device. 

 
Date:  8.25.2023 
Principal Investigator: David Spragg, MD 
Application Number: IRB00321575 
 
 
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Participants may be given the option to participate in future research studies 
 
i. 
If biological materials are involved, please describe all the experimental procedures and analyses 
in which they will be used. 
 
N/A 
 
 
 
5. 
Inclusion/Exclusion Criteria 
 
 
Inclusion Criteria 
 
• 
18 years or older 
• 
 Paroxysmal Atrial Fibrillation   
 
Exclusion Criteria  
 
• 
Non-English speaking  
• 
Does not own an iPhone 5 or newer 
• 
Moderate to severe mitral stenosis 
• 
Presence of Artificial Heart Valve  
• 
Severe valvular disease (any) 
• 
Physical disability that would preclude technology use, safe and adequate exercise performance 
• 
Hearing or Visual Impairment that would preclude technology use  
• 
History of fall one or more times in the last year  
• 
Hypertrophic obstructive cardiomyopathy with peak resting left ventricular outflow gradient of 
>25 mmHg 
• 
Known aortic dissection 
• 
Severe resting arterial hypertension (SBP >200 mmHg or diastolic BP >110mmHg) upon 
enrollment (obtained during clinic visit) 
• 
Mental impairment leading to inability to cooperate with study procedures  
• 
Untreated high degree atrioventricular block 
• 
History of cardiac arrest, sudden death 
• 
History of MI  
• 
Left ventricular ejection fraction <40% 

 
Date:  8.25.2023 
Principal Investigator: David Spragg, MD 
Application Number: IRB00321575 
 
 
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• 
Clinically significant depression  
• 
Presence of implanted cardiac device  
• 
Incomplete revascularization procedure 
• 
Pregnancy (pregnancy status will be determined by self report and at enrollment patients will be 
asked to report if they become pregnant in which case they will be asked to stop participating in 
the study and their data will be excluded from the intention to treat analysis. Of note, Afib 
generally affects older individuals with only <0.1% prevalence of Afib in women under age of 55). 
• 
Previous open-heart surgery  
• 
Unsafe to participate in the program as per treating clinician  
 
 
6. 
Drugs/ Substances/ Devices 
a. The rationale for choosing the drug and dose or for choosing the device to be used. 
b. Justification and safety information if FDA approved drugs will be administered for non-FDA 
approved indications or if doses or routes of administration or participant populations are 
changed. 
c. Justification and safety information if non-FDA approved drugs without an IND will be 
administered.  
 
1. The Corrie app is available on iPhone 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. Apple Watch, Itamar Watch PAT, and Omron blood pressure cuff all have received FDA 
clearance and are safe for patient use (see supplementary documents). 
 
 
7. 
Study Statistics 
a. Primary outcome variable. 
b. Secondary outcome variables. 
c. Statistical plan including sample size justification and interim data analysis. 
d. Early stopping rules. 
 
In this two-arm, parallel group RCT we will evaluate feasibility (primary outcome) of a 12-week Corrie AF 
digital toolkit intervention. We will recruit a convenience sample of 100 patients with paroxysmal atrial 
fibrillation. With 100 patients enrolled we would be able to detect difference in quality of life measured 
by AFEQT of ~ 19 points with 80% power and 0.05 alpha but it would be unlikely to see such large effect 
size with 12 week intervention. Similarly, we will be able to detect 10% difference in AF burden, previous 
studies have shown 7.6% point reduction in AF burden with 12 week exercise program and given our 
comprehensive approach we anticipate that we will achieve at least 10% difference in AF burden from 
baseline to follow up in the intervention group. 
 
 

 
Date:  8.25.2023 
Principal Investigator: David Spragg, MD 
Application Number: IRB00321575 
 
 
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8. 
Risks 
a. Medical risks, listing all procedures, their major and minor risks and expected frequency. 
b. Steps taken to minimize the risks. 
c. Plan for reporting unanticipated problems or study deviations. 
d. Legal risks such as the risks that would be associated with breach of confidentiality. 
e. Financial risks to the participants. 
 
 
Risks include feeling tired with filling out surveys. Other risks include risk of adverse events with diet 
and exercise. However weight loss is class I recommendation by American Heart Association and 
American College of Cardiology guidelines for atrial fibrillation patients. We will not ask patients to do 
extreme diet or engage in exercise that is beyond what they can safely tolerate. Furthermore, we 
have implemented the following interventions to further minimize the risk (1) We will exclude 
patients who are not deemed fit for study participation by treating clinician (2) We will only enroll 
participants in the study who have significant comorbidities (see exclusion criteria)  (3) We will 
provide nurse led weekly check-ins with patients to guide them accordingly if their vitals are not 
within normal range or if patients report concerning symptoms. The guide for these check-ins has 
been compiled based on the Johns Hopkins cardiac rehabilitation program and atrial fibrillation clinic 
protocols and is attached in supplementary document section.  
 
Risks also include patient relaying on study clinician during the Afib episode that is causing medical 
emergency. To minimize this risk, we will have disclaimer that if patients are experiencing medical 
emergency, they should call 911. Otherwise patients will be connecting with healthcare team as they 
would in usual care team, except they will have option to use the App to make the connection.  
  
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. 
 
There are no study procedures that would put patient at financial risk.   
 
 
9. 
Benefits 
a. 
Description of the probable benefits for the participant and for society. 
 
 
Overall, the participants in the intervention group will be given access to a Corrie Vcare Afib program. 
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 physical activity and develop 
skills that help them manage their medications as well as follow-up appointments with their 
clinicians. Patients enrolled in usual care may not derive significant direct benefit. Moreover, the data 
that they contribute as a research participant could help others in the future. 
 
 
 

 
Date:  8.25.2023 
Principal Investigator: David Spragg, MD 
Application Number: IRB00321575 
 
 
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10. 
Payment and Remuneration 
a. 
Detail compensation for participants including possible total compensation, proposed 
bonus, and any proposed reductions or penalties for not completing the protocol. 
 
 
The Corrie App, Apple Watch, One time Itamar Watch PAT home sleep study,  blood pressure 
monitor, and scale will be provided to participants if they do not own one at no cost to the them. If 
participants opt to continue using devices after the completion of the program they will be allowed 
to do so. Participants randomized to usual care arm will be provided with blood pressure cuff, scale 
as well as home sleep study test after the completion of 12 week follow up surveys.  
 
 
11. 
Costs 
a. 
Detail costs of study procedure(s) or drug (s) or substance(s) to participants and identify 
who will pay for them. 
 
Costs associated with hardware and software support for Apple Watch and Watch PAT single use 
home sleep study will be covered by companies, Apple and Itamar.  
 
 
12. 
Transfer of Materials 
Transfer of biospecimens from Johns Hopkins to another organization for research purposes and 
receipt of biospecimens from an outside organization for your research must adhere to JHU 
policies for material transfer (https://ventures.jhu.edu/faculty-inventors/forms-policies/ ) and 
biospecimen transfer 
(https://hpo.johnshopkins.edu/enterprise/policies/176/39187/policy_39187.pdf?_=0.62232423
2879).  
 
Please complete this section if your research involves transfer or receipt of biospecimens. 
 
a. Will you receive biospecimens from an external entity for this research? [Yes/No].  
 
If “Yes”, please confirm you will secure an MTA/research agreement from the appropriate office 
 
(JHTV/ORA) prior to transfer.  
 
See: https://ventures.jhu.edu/technology-transfer/material-transfer-agreements/ . 
 
b. Will you transfer biospecimens to an external entity as part of this research? [Yes/No] 
 
If “Yes”, please address each of the following: 
1) Describe the nature of the research collaboration with the external entity and the rationale 
for the transfer. (Include an explanation of your intellectual contribution to the design of the 
research study, resulting data and sharing, and participation in the planned publications.) 
2) Please confirm you will secure an MTA through the appropriate office (JHTV or ORA) prior to 
transfer. 
(See: https://ventures.jhu.edu/technology-transfer/material-transfer-agreements/.) 
  
3) If the biospecimens you intend to transfer were obtained through clinical or research 
procedures at Johns Hopkins and “Other” is selected in Item 4, Section 23, please submit the 
following items in that Section: 

 
Date:  8.25.2023 
Principal Investigator: David Spragg, MD 
Application Number: IRB00321575 
 
 
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Version 4 Dated:   01/2021 
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a. A pdf version of a completed JHTV Online “Material Transfer Agreement Request 
Form for Outbound Material” https://ventures.jhu.edu/technology-
transfer/material-transfer-agreements/ OR a copy of the COEUS PD (Proposal 
Development Summary). 
b. A completed Biospecimen Transfer Information Sheet 
https://www.hopkinsmedicine.org/institutional_review_board/forms/.   
c. A signed and dated “De-identified Human Subject Certification” 
https://www.hopkinsmedicine.org/institutional_review_board/forms/  
d. Approval documents from recipient site, if applicable. 
e. Copies of the consent forms associated with the IRB protocols under which the 
biospecimens were collected, with language appropriate to this transfer highlighted.  
f. The name of the specialist you are working with in ORA to complete a contract/MTA. 
Please see the following website for more information about transferring human biospecimens to 
outside entities: 
https://www.hopkinsmedicine.org/institutional_review_board/news/announcement_transfer_h
uman_biospecimens_outside_entities.html/ .   
 
 
 
 
 
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