Smartwatch Monitoring for Atrial Fibrillation After Stroke
Phase: NA
Conditions: Stroke, Atrial Fibrillation
Sponsor: University of Massachusetts, Worcester

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Study Protocol 
 
Smartwatch Monitoring for Atrial Fibrillation After Stroke 
 
NCT #: NCT03761394 
Date of Document: May 27, 2020 

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1) 
Study Title 
Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke 
 
2) 
IRB Review History* 
The application has never been submitted for review by an external IRB. NHLBI R01HL137734-
01A1 from the NIH is funding this project. 
 
3) 
Principal Investigator 
Timothy Fitzgibbons, M.D. PhD.  
 
4) 
Objectives* 
The objectives of this project are to develop a mobile device application with providers and 
patients that is both usable and accurate. The mobile device application will collect and extract 
RR interval data and use real-time algorithms for accurate detection of atrial fibrillation (AF) from 
mobile devices, including a smartwatch.  Our central hypothesis is that a wrist-based wearable 
paired with a smartphone application will detect paroxysmal AF (pAF) with high sensitivity and 
specificity when compared to conventional cardiac monitors and will be found acceptable by 
stroke and cardiology patients and their providers. To accomplish this goal, our study will have 
two phases, a developmental phase and a testing phase. The overall objective will be 
accomplished by testing our central hypothesis after achieving the following specific aims: 
 
Part I (Aim 1): 
-To develop a robust and comprehensive mobile device application for analysis of heart rate 
interval series followed by real-time detection of paroxysmal AF and atrial flutter using our 
previously developed AF detection algorithm using smartwatch. 
 
-To increase the accuracy and acceptability of our smartwatch-based pAF detection technology 
by involving older stroke patients and their providers in the design of the application. 
 
Part II (Aims 2-3): 
-To evaluate the performance of a smartwatch for pAF detection in stroke patients and/or to 
monitor patient who are at stroke risk with CHA2DS2-VASc score >3 by examining over 14 days 
the accuracy of pAF detection from Pulsewatch vs. a state-of-the-art cardiac monitoring device. 
 
-To evaluate rates of adherence and factors associated with successful longer-term smartwatch 
use among up to 60 randomly selected stroke patients and/or who have a CHA2DS2-VASc 
score >3 enrolled in our 14-day validation study. These randomly selected participants will be 
asked to use the smartwatch/phone dyad for 30 days. We will explore the impact of smartwatch 
use over 30 days on patient-reported quality of life, anxiety, and self-efficacy compared up to 60 
usual-care patients.  
 
Learnings from these new objectives will support our future goal to extend monitoring periods to 
many months or years, surpassing the capabilities of event monitors. 
 
5) 
Background* 
Atrial Fibrillation (AF) is the most common sustained dysrhythmia worldwide. Although new AF 
treatment strategies have emerged over the last decade, a major challenge facing clinicians and 
researchers is the paroxysmal, often short-lived, and frequently asymptomatic nature of AF. 
Given that paroxysmal and asymptomatic AF is a growing clinical and public health problem, 
better, less expensive, and more readily available AF detection technologies are needed. There 

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is, therefore, a pressing need to develop methods for readily-accessible monitoring devices 
powered by accurate AF detection algorithm in order to improve patient care and reduce 
healthcare costs associated with treating these arrhythmias and their complications.  
 
Novel technologies for AF detection have important clinical and research applications for AF 
screening and monitoring. As was emphasized by a recent National Heart, Lung and Blood 
Institute (NHLBI) expert panel, there is a pressing need to develop methods for accurate AF 
detection and easily accessible monitoring devices. To this end, we have previously developed 
a sensitive, real-time realizable algorithm for accurate AF detection using commercially 
available, clinically applicable electrocardiographic recordings. Our AF algorithm has been 
tested using the MIT-BIH AF database and Holter recordings, shown to be accurate, and is now 
commercially available in a new Holter monitor from Scottcare Corporation.  We have also 
made improvements to the algorithm so that it can detect AF episode that is as short as 12 
beats. Further, we have recently developed a software application to measure heart interval 
series, which can be used to detect AF in real time from pulse plethysmographic (PPG) devices. 
Given the ever-growing popularity of smartphones and smartwatches, our approach to AF 
detection using a mobile device will give patients as well as healthcare providers the opportunity 
to monitor these arrhythmias under a wide variety of conditions outside of the physician’s office 
and outside of the patient’s home.  
 
Because our approach uses only standard smart device hardware (e.g., iPhone or Samsung 
watch), it is cost-effective, thereby leading to better acceptance and use by patients. Our mobile 
health for AF detection platform has the potential to markedly change the traditional delivery of 
healthcare, allowing for more frequent, rapid, and patient-directed AF detection. We will test the 
acceptability and accuracy of our smartwatch-app dyad using smart devices (a smartphone and 
smartwatch) to be collected from recruited stroke or transient ischemic attack survivors at risk 
for AF or patients with a CHA2DS2-VASc score of > 3 at risk for a stroke or transient ischemic 
attack. We believe this research will result in rapid translation into innovative AF detection 
solutions, leading to more effective monitoring and diagnosis of these common arrhythmias. 
Finally, the proposed work has the potential to significantly reduce healthcare costs and 
enhance patient care by accurately and rapidly establishing the diagnosis of AF in at-risk 
groups, thereby providing clinicians with an opportunity to prevent secondary complications of 
these life-threatening arrhythmias. 
 
Stroke survivors and individuals at high risk for incident stroke require cardiac 
monitoring for AF, the single greatest risk factor for stroke: Current American Stroke 
Association stroke management guidelines recommend: “For patients who have experienced an 
acute ischemic stroke or TIA with no other apparent cause, prolonged rhythm monitoring (≈7-14 
days) for AF is reasonable” and recommended. In addition, patients with AF risk factors, 
including hypertension, diabetes mellitus, vascular disease, and prior episodes of AF or atrial 
flutter should be monitored for recurrence. This is because AF is the primary cause of ~15% of 
all strokes and AF recurrence and burden relate to stroke. Moreover, patients with AF, if not 
treated with anticoagulation therapies, tend to have larger strokes that lead to significant 
disability. One in 4 patients leaves the hospital without a cause of their stroke identified 
(cryptogenic strokes). Of the 200,000 American patients diagnosed with cryptogenic stroke 
yearly, 1 in 5 has paroxysmal AF identified if long-term post-discharge cardiac monitoring is 
used. Unfortunately, traditional in–hospital monitoring following stroke identifies AF in only ≈5% 
of cases and longer-term monitoring, although effective, is rarely used as it presently 
necessitates the implantation of an expensive invasive device (e.g., Medtronic LinQ monitor or 
pacemaker).  

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Most existing smartphone apps can detect heart rate, but they cannot detect cardiac rhythm. AF 
detection algorithms used in cardiac devices and monitors are rudimentary and require the use 
of electrodes or invasive devices implanted underneath a patient’s skin. AliveCor - a 
smartphone-based arrhythmia detection platform - pairs ECG electrodes with a smartphone 
running a proprietary app, enabling single-lead ECG and intermittent pAF monitoring. No 
existing algorithm for AF detection uses the combination of passive monitoring, pattern 
recognition, computational speed, and robust noise cancellation routines our solution employs. 
Additionally, although there are several smartwatches and wearables, including those from 
Apple, Philips, and Fitbit, that are capable of heart rate monitoring, the Samsung platform offers 
3 unique advantages: 1) provides researchers with access to a secure data management 
system designed for research (Artikcloud), 2) allows for independent development of open-
source applications, 3) has a smartwatch capable of out-of-the-box pulse monitoring. 
 
In our new “Pulsewatch study,” we propose to hone our existing smartphone app to 
work with a smartwatch in concert and in a manner that is accessible and usable by 
elders with, or at risk for, stroke with input from expert providers and patients. The app 
will use prompts to promote adherence to daily use of the smartwatch during the monitoring 
period and will prompt participants to perform a pulse check if they experience a symptom of 
AF. 
 
6. Inclusion/Exclusion Criteria 
 
Part I: Design/Development of the app-smartwatch dyad 
 
Patient (and Caregiver) Focus Groups and Hack-a-thon (Part 1): 
Inclusion: For patients: history of TIA or stroke, presenting at the UMass Memorial Medical 
Center (UMMMC) inpatient service or ambulatory clinic (neurology clinics and cardiovascular 
clinics included), age ≥ 50 years. For patient caregivers: history of caring for a family member or 
loved one with the inclusion criteria listed above in the last five years. For both patients and 
patient caregivers: able to sign informed consent, and willing to participate in a focus group 
and/or Hack-a-thon.  
 
Exclusion: For both patients and patient caregivers: serious physical illness (e.g., unable to 
interact with a smart device, or communicate verbally or via written text) that would interfere with 
study participation, lacking capacity to sign informed consent, unable to read and write in 
English, plans to move from the area during the study period, unwilling to complete all study 
procedures, including attending a focus group and/or Hack-a-thon.  
 
Provider Focus Groups and Hack-a-thon for Part 1: 
Inclusion: medical provider (i.e., cardiology fellow or neurology resident, attending cardiologist, 
attending neurologist, stroke or cardiology nurse practitioner) at UMMMC, >3 years of 
experience providing care to stroke or TIA patients, willingness to complete informed consent, 
and willingness to participate in a focus group and/or Hack-a-thon. 
 
Part II: Study of the app-smartwatch dyad 
 
Inclusion: History of TIA or stroke, presenting to the inpatient UMMMC neurology service or 
ambulatory clinic (neurology clinic or cardiovascular medicine clinic/monitoring station), and/or 
has a CHA2DS2-VASc score >3, age ≥ 50 years, capable of signing an informed consent, willing 

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and capable of using Pulsewatch (smartwatch and smartphone app) daily for up to 44 days and 
returning to UMMMC for up to two study visits.  
 
A CHA2DS2-VASc score is a widely used and validated instrument recommended for use by 
cardiologists to determine stroke risk in atrial fibrillation patients. CHA2DS2-VASc score relates 
to stroke risk among individuals with AF and those free from a known diagnosis of AF. Using a 
CHA2DS2-VASc score as an inclusion criterion during screening for possible subjects will enable 
the study to approach patients at high risk for stroke who could benefit from continuous 
monitoring.  
 
Exclusion: Major contraindication to anticoagulation treatment (i.e., major hemorrhagic stroke). 
Plans to move out of the area over the 44-day follow-up period. Unable to read or speak 
English. Unable to sign consent. Unable or unwilling to return for potential study visits (up to two 
over a 44-day study period). Patients with known allergies or hypersensitivities to medical grade 
hydrocolloid adhesives or hydrogel. Patients with life threating arrythmias who require in patient 
monitoring for immediate analysis. Patient with implantable pacemaker as paced beats interfere 
with the ECG reading.  
 
Major contraindication to anticoagulation treatment is an exclusion due to the goal of this study, 
which is to help prevent secondary stroke; anticoagulation is a mainstay treatment for these 
patients. Therefore, if patients are unable to receive anticoagulation treatment, they are not in 
the ideal target population for this study.  
 
 
 
Special Populations: 
• 
Adults unable to consent - Will not be recruited for this study. 
• 
Individuals who are not yet adults - Will not be recruited for this study. 
• 
Pregnant women - Will not be recruited for this study. 
• 
Prisoners - Will not be recruited for this study 
 
If we struggle to enroll a sufficient number of participants using the campus and clinics outlined 
above, we will recruit at the stroke treatment centers or cardiology clinics at UMass Memorial - 
Health Alliance Hospital in Leominster, MA, and at UMass Memorial - Marlborough Hospital in 
Marlborough, MA. The inclusion/exclusion criteria will otherwise remain the same. 
 
 
7. Study-Wide Number of Subjects* 
 
Not a multi-site study.  
 
8. Study-Wide Recruitment Methods* 
 
Not a multi-site study 
 
9. Study Timelines* 
 
The first year to 1.5 years of the study will be focused on achieving Aim I (Part I – design of the 
application). Focus groups will be scheduled on a rolling basis over Year 1 and will be strongly 
influenced by the coordinator and room availability, as well as participant preference. The Hack-

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a-thon will also be scheduled at or around the end of Year 1 of the study (Spring 2019). 
Participants will be advised of when the event will be held. 
 
Enrollment for Aims 2-3 (Part II) will begin in Year 2 and will run for 3 years. At enrollment, 
participants will be asked to use a cardiac monitor for 14 days and return for a study visit to 
evaluate device usability and accuracy. Thereafter, we will ask a randomly selected subsample 
to continue to use the device for an additional 30 days for a total of 44 days. We will hold 
additional semi-structured exit interviews for select Aim 2 intervention participants who used the 
Pulsewatch devices for 14 days.  
 
The Pulsewatch study will be conducted over a 4-year period; see table below. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
10. Study Endpoints* 
Not only will we achieve our central hypothesis with our aims, but we will be able to complete 
the following endpoints as well:  
 
Part I:  
• 
Using focus groups, we will gain feedback on the: 
o App prototype and system as a whole 
o Role of caregivers in technology use 
o Barriers and facilitators of use 
o Preferences and usability of features  
o Enhancements to text and ambient messaging  
o Communication system design 
o Provider preferences regarding notification criteria and format 
o Potential implementation settings 
o Information display, graphical images, and message content 
 
• 
Hack-a-thon endpoints will ensure developers:  
o Hear patient and provider needs  
o Obtain feedback on information display, graphical images, and message content 
Study Year  
1 
2 
3 
4 
Quarter 
1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4
DEVELOPMENT/ENHANCEMENT (Aim 1)  
Formative patient focus 
groups & provider interviews 
  
 
 
 
 
 
 
 
 
 
 
 
 
  
Analysis of formative 
qualitative data 
  
 
 
 
 
 
 
 
 
 
 
 
 
  
“Hack-a-thon” Stakeholder-
Agile Team Meeting 
  
 
 
 
 
 
 
 
 
 
 
 
 
  
Refine & Integrate AF, skin 
contact, & MNA algorithms 
  
 
 
 
 
 
 
 
 
 
 
 
 
  
EVALUATION/DEPLOYMENT (Aims 2 and 3) 
Smartwatch deployed in 
stroke population 
  
 
 
 
 
 
 
 
 
 
 
 
 
  
Follow-up interviews/exit 
interview assessment of app 
  
 
 
 
 
 
 
 
 
 
 
 
 
  
Data analysis 
  
 
 
 
 
 
 
 
 
 
 
 
 
  

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Part II:  
• 
Quantitative Endpoints: We will evaluate the performance of the application for detection 
of atrial fibrillation compared to a gold-standard ECG monitor. We will also evaluate 
adherence to the system and factors associated with adherence.  
• 
Qualitative Interview Endpoint: Impact of app use on quality of life, anxiety, and self-
activation (using our questionnaire at baseline, at the 14-day follow-up, and the 44-day 
follow-up). This information will be obtained from study questionnaires administered at 
enrollment, at the end of Aim 2 at 14 days post-enrollment, and after study completion 
44 days post-enrollment, as well as from exit interviews convened with up to 30 selected 
participants after they use the system. 
 
11. Procedures Involved* 
 
 
Focus groups (Part 1) 
Focus groups will be used to help inform the app development and will include patients, patient 
caregivers, and provider participants. Focus groups with patients and patient caregivers will 
occur together, and provider focus groups will be conducted separately. Focus groups will last 
for approximately 60 minutes. Qualitative data analysis will generate aggregated preferences 
and recommendations about smartphone application message components, user interface, 
reporting, alerts, and watch functions. Focus group/interview analyses will inform the Hack-a-
thon and finalize the Pulsewatch design.  
 
All participants (patients, caregivers, and providers) will be told by the study team that their 
feedback is appreciated and if they feel uncomfortable at any time of the focus group, they have 
the right to refuse to answer any question(s) and the right to opt-out of the study at any time.  
 
Part I: Semi-structured and open-ended agendas for the focus groups and/or provider 
interviews have been written and are submitted as part of our application packet. Discussions 
will be audio-recorded and transcribed, protecting confidentiality by replacing participants’ 
names with study IDs.  Focus groups will begin with a broad description of the Pulsewatch 
system (including smartphone app and watch), its purpose, and general functionality. Each 
participant will be given a smartwatch and smartphone programmed with the Pulsewatch app 
and AliveCor ECG app and will be asked to use them during the focus group. In keeping with 
contemporary user-centric app design processes,80,81 facilitators will interact with participants as 
they use the smartwatch and smartphone app. After users have time to wear the watch, perform 
an ECG, review their data, and use the annotator, we will invite them to ask open-ended 
questions to explore elements such as the following: the layout of the result and summary 
screens, including the graphical representation of heart rate and rhythm (e.g., bar graph, slider, 
stoplight, faces); alert and adherence prompts, including the number of acceptable prompts that 
Pulsewatch can deliver per day; opinions about personalized intervention messages (e.g., “Mr. 
Jones, you’ve not checked your ECG”); and their preferred timing.  
 
Provider interviews will also explore what data outputs the clinicians consider ideal, along with 
when and how often they would want to receive them. We will conduct up to 6 focus groups with 
participants and up to 2 focus groups with providers as part of Part I over a 6-month period, then 
will pause to review the data. If there is strong consensus or saturation on key areas, we will 
stop. 
 
Hack-a-thon (Part 1):  

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The PI, Co-Is, 4 participants, 4 provider champions, and computer programmers and engineers 
from the University of Connecticut (UConn) will meet at the University of Massachusetts Medical 
School (UMMS) in a conference room to create the final Pulsewatch technology to be deployed 
in Aims 2 and 3. Modeled on “Hack-a-thons” in the software engineering industry, we will drive 
innovation by creating team synergy and accelerating product development. This meeting will 
likely occur in the Albert Sherman Center 7th floor conference room. Patient participants will 
receive parking vouchers and compensation. Providers will not be compensated. Light 
refreshments will be provided for all. The meeting will take place over a single day (8-hours) to 
accommodate the busy schedules of providers and participants. After the Hack-a-thon, the 
study team will meet to review and encode changes to the application. 
  
The purpose of the Hack-a-thon meeting is to optimize the interactivity and usability of 
Pulsewatch, guided by information gleaned from focus groups. Using this format, end users 
(providers and patients) can suggest changes, and programmers will make modifications in real-
time. Using a combination of focus groups and agile programming is an innovative as well as 
sound approach to designing apps. This event will be a critical aspect for Aims 2 and 3 to help 
develop the interface and management of the app for patients to use. At the Hack-a-thon, 
participants will be asked to use a prototype of the Pulsewatch app and the system, and then 
provide feedback on what they think of the system. Programmers will make modifications to the 
application in real time. While programmers are making those modifications, participants may 
take a break during the Hack-a-thon, and then come back at a later time during the event to see 
the final product.  
 
The individuals who will be invited to this Hack-a-thon event will be participants and providers 
from the focus groups. At the focus groups, we will provide a fact sheet about the day-long 
Hack-a-thon and a contact sheet for people who may be interested in being invited. We will 
explain that they may accept or decline the invitation. (Please see Fact Sheet: Patient Hack-a-
thon in our eIRB submission). Study staff will follow-up with interested participants and providers 
by telephone or email. Participants will have the option to opt-out or confirm their attendance at 
the Hack-a-thon.  
 
Part II, Trial Phase- The trial phase of the study will occur after the design and development of 
the Pulsewatch system (app and watch algorithms) is complete (Part I). For Aim 2 of Part II, 
participants will be randomized into either the intervention or control arm of the study. The Aim 2 
control participants will wear a gold standard cardiac monitor patch (two patches over the 14-
days) but will not be offered use of the Pulsewatch system. Please view visual Diagram 1a for 
an overview of the 14-day participant process. 
 
 
 

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Diagram 1a. Participant process of trial phase: Group names are corresponding to the 
Part II Consent V1.2 form submitted in eIRB.  
 
Part II:  
At baseline, participants in the Aim 2 control group (up to n=30) will be given two gold-standard 
Cardiac Insight Cardea Solo patch monitors. Each patch will run for 7-days to  automatically 
monitor for and capture irregular heartbeat data. This patch goes right over a participant’s heart 
on their skin. This patch will allow participants to go home with a continuous AF monitoring 
method without the hassle of carrying around a bulky Holter device. Our PI has already worked 
with similar devices in the past and has built a relationship with the study team to ensure proper 
care and transmission of the data. Trained study staff will place the patch on the participant at 
Randomization 
(3:1) 
Eligible UMMMC 
patient screened by  
trained study staff 
2 Patches 
Control: (up to n=30) 
Intervention: (up to n=90) 
Pulsewatch 
System 
DEVICES GIVEN 
POST CONSENTING 
• Completes baseline 
questionnaire 
• Given handouts 
regarding devices 
• Device placed (1 patch) 
by trained study team on 
participant 
o Compensated: 
$100 gift card 
• Completes baseline 
questionnaire 
• Given handouts regarding 
devices 
• Device placed (1 patch) by 
trained study team on participant 
o Compensated: $100 gift 
card 
POST 14-DAYS 
• Completes follow-up 
questionnaire 
• Returns devices  
o Compensated: 
$100 gift card 
• Randomized into either 
Aim 3 intervention or 
control 
• Completes follow-up questionnaire 
• Returns devices  
o Compensated: $100 gift 
card 
• Completes exit interview (up to 30 
participants) 
o Compensated: $60 gift card 
• Randomized into either Aim 3 
intervention or control 
2 Patches 
To be worn: 
 
Days 1-7 
 
 
 
Days 8-14 
To be worn: 
 
Days 1-7 
 
 
 
Days 8-14 
Group 
A 
Group 
B 

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the baseline visit. There is little risk to the participant from this device, which is widely used 
technology. The major risk with this device is participant discomfort or skin irritation. Participants 
will be given a number to contact in the event they have discomfort in the 14 days of using the 
device. Participants will be given a handout with instructions and care tips for the patch (see 
Device Handout in eIRB). Only certain sections of this handout will be given to participants 
depending on which arm of the trial they are assigned to. Aim 2 control participants will be 
asked to remove the first patch at the end of day 7 and replace it with the second provided 
patch and wear it for the next 7 days. They will be asked to return both patches at their follow-up 
visit (approximately 14 days). At their study visit, the participants will be asked to complete an 
exam and questionnaire that includes standardized scales. Aim 2 control participants will be 
compensated for their time and effort, as outlined above. The device will be read by a study 
physician blinded to intervention/control status. Abnormal findings on the monitoring patch, in 
either the intervention or control groups, will result in notification to the participant’s treating 
physician.  
 
All participants will be given a Device Handout regarding instruction for the appropriate devices 
they are given. In addition, the study team will review with each participant all instructions 
regarding how the Cardiac Insight patch functions and the participant’s responsibility. The 
participant will also go home with information regarding the patches (see in eIRB, Cardea Solo 
Quick start guide- this will be added the Device handout). The study team, specifically the PI, 
may need to contact participants directly about their results. This will be disclosed in the 
informed consent form that participants sign.  
 
The Aim 2 intervention participants (up to n=90) will be asked to use the same gold-standard 
Cardiac Insight patch monitor device for 14 days as the control group described above. Aim 2 
intervention participants will also be given a Samsung smartwatch and a Galaxy smartphone. 
The Samsung smartwatch and Galaxy smartphone are standard devices that are sold 
commercially and will be labeled, nonetheless, as research devices. If the participant has a 
smartphone that is compatible to our Pulsewatch app, then we will download the app onto the 
participant’s smartphone.   
 
The Aim 2 intervention group (up to n=90) will be asked to self-monitor using the Pulsewatch 
system for at least 9 hours daily for 14 days. The intervention system is designed to be 
minimally intrusive. Participants will be asked to return all study devices (2 Cardiac Insight 
patches, Samsung smartwatch, and Galaxy smartphone) at the end of their 14 days of use at 
the follow-up study visit. Participants will be asked to complete a questionnaire at this follow-up 
study visit and will be compensated.  
 
At enrollment in Part II, all study participants will be informed of the possibility that they may be 
randomly selected at the completion of their 14-day monitoring period to use the Pulsewatch 
system for up to 30 days. We chose to assign a larger proportion of participants to the Aim 2 
intervention group because the primary analyses for Aims 2 and 3 are focused on Pulsewatch 
users.  
 
 
 
 

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Diagram 1b. Participant process of Part II, trial phase. This diagram outlines what the 
participant process is after 14 days and after 44 days. Group names are corresponding to 
the Part II Consent V1.2 form submitted in eIRB. Please note: for this “Randomization*” we 
would like to ask permission from the IRB for an adaptive plan; refer to section 13 Data Analysis 
and Management, sub section AF Detection Analysis for this plan.  We have provided further 
details about this process below. 
 
To accomplish Aim 2, we will examine the performance of Pulsewatch monitoring compared to 
conventional cardiac monitoring for pAF detection (accuracy of detection). We will also explore 
the participant factors (e.g., hearing or cognitive impairment) associated with app performance.  
By enrolling patients from  both inpatient and outpatient clinical settings, we will be able to 
recruit patients who have stroke/TIA and/or who are at risk for stroke (deemed to have a 

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CHA2DS2-VASc score >3). At the end at 14 days, if less than 5% of participants have AF based 
on the gold-standard Cardiac Insight patch, then we would like to ask participants to extend the 
use of their monitors for further monitoring. (See Section 13, Data Analysis and Management, 
AF Detection Analysis.) 
 
To accomplish Aim 3, we will randomly select 60 participants from both the intervention group 
and the control group of Aim 2 at the end of the 14 days and ask them to continue using, or 
begin using, the Pulsewatch system to upload their pulse recordings. We will also provide 
participants randomized to the Aim 3 intervention group with a gold standard AliveCor Kardia 
mobile ECG device to use if they wish to verify their pulse reading from the smartwatch. We will 
also examine factors (e.g., vision) participants report related to their adherence to using the 
Pulsewatch system. The 60 participants randomly selected to the Aim 3 control group will not 
use any devices during this time. 
 
Part II Exit interviews:  We will use exit interviews for Part II Aim 2 intervention trial participants 
to identify ‘what worked’ and ‘what didn’t work’. The exit interviews will be in addition to the 
questionnaire and will take place at the same study visit depending on the participants 
schedule. We will also solicit feedback on the Interactivity Manager and Annotation Panels, 
features that will be developed too late in Aim 1 to be fully explored by Aim 1 focus groups. We 
will invite up to 30 Aim 2 intervention participants to complete an exit interview. Exit interviews 
will happen after the participant’s 14-day study visit. These exit interviews will be important for 
usability data collection and overall feedback from the participants. Each exit interview will last 
for approximately 30 minutes. Semi-structured tentative and open-ended agendas have been 
written and submitted to the IRB as part of our packet (see in eIRB, Exit Interview Usability 
Script V1.0). Discussions will be audio-recorded and transcribed, protecting confidentiality by 
replacing participants’ names with study IDs. Consent for interviews and taping will be part of 
the study consent. 
 
Questionnaire-   
Part II (only): 
At enrollment and at their 14-day follow-up study visits, all Part 2 participants will complete a 
questionnaire that includes standardized scales to assess quality of life (QoL), depression, 
anxiety, and self-activation. Questionnaires will take approximately 45 minutes to complete. If a 
participant does not return for a follow-up study visit or is unable to complete an in-person 
questionnaire assessment, then a phone call will be made to the participant to see if they are 
willing to complete the questionnaire via a phone assessment. These participants will still need 
to return their devices to receive compensation. We will permit phone calls and assist with 
return by mail on a case-by-case basis.    
 
We will compare changes from baseline to the 14-day follow-up in these measures between the 
Aim 2 intervention (n=90) and Aim 2 control (n=30) groups.  
 
At the end of each participant’s 44-day enrollment, they will complete a questionnaire either 
over the phone or in person, whichever is easier for the participant, to assess QoL, anxiety, and 
self-activation. This questionnaire will take approximately 20 minutes to complete. Participants 
who were not randomly chosen to use the Pulsewatch system for 30 days (Aim 3 control group) 
will receive compensation upon completion of the 44-day follow-up questionnaire. Participants 
who were randomly chosen to use the Pulsewatch system for 30 days (Aim 3 intervention 
group) will receive compensation upon completion of the 44-day follow-up questionnaire and 
return of their devices. 

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We will compare changes from the 14-day follow-up to the 44-day follow-up in these measures 
between the Aim 3 intervention (n=60) and Aim 3 control (n=60) groups. 
 
We will create a short-form questionnaire assessment in the event that a participant is unable to 
complete the full questionnaire. The only difference between the full assessment and short form 
is that the short form will contain only outcome measurements for the questionnaire.  
Here is an overview of the variables our questionnaires will be collecting. We have uploaded all 
of our questionnaires to eIRB.  
 
Measurement 
Questionnaire Tool 
Outcome 
or 
Stratifier 
Baseline 
Assessment 
(All Part II) 
14-Days 
Follow-up 
Assessment 
(Control) 
14-Days 
Follow-up 
Assessment 
(Intervention) 
44-Days 
Follow-up 
Assessme
nt (All Part 
II) 
Physical assessments 
Vision 
Questionnaire (4 items) 
Stratifier 
✓  
 
 
 
Hearing 
Questionnaire (3 items) 
Stratifier 
✓  
Psychosocial measures 
Cognitive 
impairment 
MoCA (30- items) 
Stratifier 
✓  
 
 
 
Social support 
Social Support Scale (5 items) 
Stratifier 
✓  
Lubben Social Network Scale (6 
items) 
Stratifier 
✓  
Depressive 
symptoms 
PHQ-9 
Stratifier 
✓  
Anxious 
symptoms 
GAD-7 
Outcome 
✓  
✓  
✓  
✓  
Quality of life measures 
 Physical and 
mental health 
Health survey SF-12 (12 items) 
Outcome 
✓  
✓  
✓  
✓  
Patient 
activation 
CHAI (10-items) 
Outcome 
✓  
✓  
✓  
✓  
Disease 
management 
self-efficacy 
Stanford Chronic Disease 
Management Self-Efficacy Scales: 
Manage Disease in General Scale 
(5 items) 
Outcome 
✓  
✓  
✓  
 
Stanford Chronic Disease 
Management Self-Efficacy Scales: 
Manage Symptoms Scale (5 
items) 
Outcome 
✓  
✓  
✓  
 
Medications  
Medication 
adherence 
 Adherence to Refills and 
Medication Scale (ARMS) (12-
items) 
Outcome 
✓  
✓  
✓  
 
Health Related Behavior 
Social history 
Smoking and alcohol use 
Stratifier 
✓  
 
 
 
Other 
Interaction with 
provider 
Perceived Efficacy in Patient –
Physician interactions (PEPPI) 
Stratifier 
✓  
 
 
 
Technology 
use 
Device ownership/internet access 
Stratifier 
✓  
 
 
 

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Aims 2-3: Questionnaire will include the following domains- 
Anxiety: Anxiety will be assessed using the Generalized Anxiety Disorder-7 scale (GAD-7),86 a revised 
version of the anxiety module from the Patient Health Questionnaire, which consists of DSM-IV criteria for 
generalized anxiety disorder over the past 2 weeks.87 The GAD-7 score ranges from 0-27 with scores of 5, 10 
and 15 representing validated cut-points for mild, moderate and severe levels of anxiety symptoms, with a 
score ≥10 having high sensitivity (0.89) and specificity (0.82) for psychiatrist diagnosed anxiety disorder and 
correlates significantly with health-related QoL. 86￼ 
Physical and mental health: The SF-12 is a short form health survey to assess health related quality of life, 
this validated instrument domains include general health questions and mental health related questions.116 
Scores range from 0 to 100, where higher scores indicate higher level of health.  
Patient Activation: Patient activation refers to a patient’s ability and willingness to manage their health 
Consumer health activation index (CHAI) is a 10-item scale. Scores range from 10 to 60 the higher the score 
the higher the activation the patient has for self-management of their condition. This is a validated 
questionnaire instrument.  
Cognitive function: The Montreal Cognitive Assessment Battery (MoCA)94 is a 10-minute, 30-item 
screening tool designed to assist physicians in detecting mild cognitive impairment. MoCA correlates well 
(.89) with the widely used Mini Mental State Exam,95 but outperforms it in the detection of mild cognitive 
impairment (CI).94,96  The MoCA score can be used to examine a magnitude of change over time and offers 
validated, education-adjusted cut-points for mild CI and dementia.. 
Social Support: We will use a 5-item modified Social Support Scale and the 6-item Luben Social Network 
Scale.99,100 Together these measures assess breadth (e.g., help with activities) and depth (e.g., network size) 
of the participant’s social support. 
Depressive Symptoms: We will use the 9-item version of the Patient Health Questionnaire (PHQ-9),101 the 
depression module from the Patient Health Questionnaire,87 which can yield both a provisional diagnosis of 
depression and a severity score that are associated with functional status, disability days and healthcare 
utilization.102 The PHQ-9 consists of the 9 criteria upon which DSM-IV depressive disorders are based. Using 
a cut-point of ≥10 (range = 0-27), the PHQ-9 has high sensitivity (.88) and specificity (.88) for detecting major 
depression among patients with CVD.88,104Study staff will follow UMass Extreme Emotional Distress protocol 
approved by the IRB in the event that a patient indicates suicidal thoughts.  
Vision: We will test vision using a Snellen eye chart. Participants will also be asked the question, ‘How much 
does your vision interfere with your activities?’ based on a 4-point Likert scale from ‘not at all’ to ‘a lot’.  
Hearing: We will use the Whisper test where participants are asked to repeat back numbers whispered into 
their ear.105,106 Impairment is defined as hearing ≤6 of 12 numbers. We will complement objective hearing 
assessments with subjective self-reported responses to the question: ‘How much does your hearing interfere 
with your activities?’ 
Disease Management Self-Efficacy: Self-efficacy for disease management is associated with engagement 
in health behaviors and with improved medication adherence107,108The General Disease Management scale 
is a 5-item scale assessing confidence in disease self-management (scores 0-50, higher scores = greater 
confidence). The Symptom Management scale is a 5-item scale assessing confidence in managing chronic 
disease symptoms (items tailored to sample). 
Usability 
Assessment  
System usability scale, 
Investigator generated questions  
Outcome 
 
 
✓  
 
App usability 
assessment 
Mobile Application Rating Scale 
(MARS) App Classification (11-
items) 
Outcome 
 
 
✓  
 
Demographics 
Social economic status, 
employment, race and ethnicity 
questions 
Stratifier 
✓  
 
 
 

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Medication Adherence: Medication adherence will be measured using the 12-item Adherence to Refills and 
Medications Scale (ARMS), a well-validated measure of patient-reported adherence.110 ARMS scores range 
from 1-4 (higher scores=poorer adherence). 
Social history:  Social and behavioral factors such as smoking and alcohol use are related to strokes and 
cardiovascular conditions. Given that the goal of this study is to prevent recurring strokes in this patient 
population, we believe it is necessary to obtain this information from participants. 
App usability: Mobile Application Rating Scale (MARS) App Classification (11-items) these 
questions will help us capture the participants experience with the application.  
 
 
 
  
 
 
Deployment of devices/app-  
 
Part I: Participants will use the Pulsewatch System prototype version of the app (AFExam), a 
smartphone, and a smartwatch during focus groups or a Hack-a-thon to provide feedback for 
further development of the app, and to enhance the deployment of the system in Part II of the 
study.  
 
Part II:  We will provide up to 120 randomly selected participants with an Android smartphone if 
they do not own a compatible phone. The smartphone will be active – meaning we will pay for a 
standard cellular data/voice/text plan for the duration of the study period. The smartphone will 
be preloaded with a Samsung application to enable communication with the smartwatch, the 
study software application, the AliveCor Kardia application (used in Aim 3), the participant, and 
the study team. Participants who are selected for the intervention arm of Aim 3 will be given the 
AliveCor Kardia application, which is an FDA-approved, commercially available, single-lead 
ECG recording device that communicates with the smartphone. Participants will also be 
provided with a smartwatch and a handout outlining how to use the devices (see in eIRB, 
Device Handout). We will ask participants to wear the smartwatch day and night for 14 days, 
removing it only to charge each morning or during a shower. The Pulsewatch app interface will 
allow participants to enter into the app symptoms they may feeling.   
 
We have selected the Galaxy Android smartphone because it can interface seamlessly with the 
Samsung smartwatch. If participants have compatible phones they want to use for the study, we 
will download the Pulsewatch and AliveCor apps onto their phones, and we will pair their 
phones with the Samsung study watch. We will also provide compensation to participants when 
they return the smartphone and watch to study staff after completing the study. Participants will 
be encouraged to call study staff with any problems encountered when using Pulsewatch during 
the 14-day monitoring period. 
 
Participants will also have a cardiac patch placed on their chest at enrollment. This monitor will 
serve as a gold-standard comparator in our study and is a diagnostic-grade, FDA-approved, and 
fully regulated medical device manufactured by Cardiac Insight. The gold-standard cardiac 
patch will be placed onto participants by trained study staff at enrollment. Participants will be 
instructed to call the study team if they have any problems with the monitor.  
 
Research staff (RA or study coordinator) will provide enrolled participants with detailed 
instructions about the operations and proper usage of the Pulsewatch smartwatch, smartphone 

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apps (including the Pulsewatch app and AliveCor app), ECG, and 14-day monitor. A checklist 
and a YouTube video may be made available to participants to remind them of how to charge, 
wear, and perform ECG self-checks using the smartwatch and phone app. Participants 
(including all control and intervention participants) will return smartphones and watches and/or 
14-day monitors after their study visit at 14 days. For Aim 2 intervention participants, pulse and 
ECG data from the smartwatch and annotations/adherence data from smartphones will be 
uploaded by study staff after the 14-day visit to the secure cloud server. Aim 2 control 
participants will be provided instructions on the gold-standard Cardiac Insight patches. Study 
staff will be available via telephone to answer any questions participants have with using the 
smartwatch and smartphone, charging the battery, and uploading data throughout the 14-day 
trial period as needed. The 60 randomly selected participants, who were consented at baseline 
to participate in this aim will receive additional training at their 14-day study visit, taught on how 
to use the AliveCor Kardia mobile device and will use the Pulsewatch smartwatch and 
smartphone for an additional 30 days. Participants in Aim 3’s intervention group will be asked to 
upload pulse and ECG data from AliveCor if they would like to do a self-check after receiving 
the watch notification. The secure server architecture used by Samsung minimizes the potential 
for loss of health information and is similar to one used in our prior work.  
 
COVID-19 Modified Study Procedures: 
During COVID-19 restrictions, we will enroll participants over the phone. To do this, we will mail 
patients a COVID-19 specific patient invitation letter and the COVID-19 specific informed 
consent form 7-14 days prior to their scheduled clinic appointment. If the patient has not called 
and opted out of the study, we will call the patient the day before their scheduled appointment to 
assess interest. If the patient is interested in participating in the study, we will review the 
COVID-19 specific informed consent form, which includes a HIPAA authorization, in which we 
replace the wet signature that was originally obtained with an acknowledgement of the study 
details, risks, benefits, and the acknowledgement to disclose protected health information 
through the process of agreeing to participate in the study. 
 
Once the participant has agreed to participate, we will then randomize the participant into either 
the intervention or control group for Aim 2. After the participant has been randomized, and we 
know what combination of devices they will be receiving, we will then mail the participant their 
specific devices with the correct device handouts that we would normally give in-person.  
 
Upon receiving the package, a phone call will be conducted with a study team member in order 
to complete the baseline questionnaire and train the participant on their respective devices. 
Each participant will be walked through how to place their Cardiac Insight patch. If the 
participant so wishes, we can also conduct this study visit over a teleconferencing system, like 
Zoom. Before completion of the study visit, the study team member will arrange the date and 
time for the participant’s 14-day follow-up visit, which will happen virtually. Our normal study 
protocol remains the same for the participant during this Aim 2 period. After this baseline visit is 
complete, we will mail the participant their $100 gift card. 
 
On the day of the participant’s scheduled 14-day follow-up visit, a study team member will call 
the participant and complete the 14-day follow-up questionnaire. Upon completion of the 
questionnaire, the participant will be randomized into an Aim 3 arm. If the participant is 
randomized into the control arm for Aim 3, we will ask the participant to mail back all of their 
Pulsewatch devices via a prepaid package. We will then mail the participant their $100 gift card. 
Our normal study protocol will be followed for the rest of these participants study period, which 
includes conducting a questionnaire over the phone 30 days later and mailing their $50 gift card. 

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For participants randomized into the Aim 3 intervention arm, we will ask them to mail back their 
Cardiac Insight patches via a prepaid package. If the participant was in Aim 2 control and is now 
in Aim 3 intervention, we will mail them the Pulsewatch System and the AliveCor Kardia Mobile 
device. We will also mail them their $100 gift card. If the participant was in Aim 2 intervention 
and is now in Aim 3 intervention, we will mail them the AliveCor Kardia Mobile device and their 
$100 gift card. Upon receiving their devices, a study team member will conduct a phone call, or 
a Zoom call, with the participant to train them on their new devices. Our normal study protocol 
will be followed for the rest of these participants study period, which includes conducting a 
questionnaire over the phone 30 days later, mailing devices back via a prepaid box, and mailing 
the participant their $50 gift card. 
 
For participants who have agreed to complete an exit interview, the interview will take place 
over the phone upon completion of the participant’s 14-day follow-up study visit. The fact sheet 
for this exit interview will be explained to the participant prior to completing the exit interview. 
We will include this fact sheet in the package we send to participants before completing their 
baseline interview, so the participant can have it to reference. If the participant misplaces the 
fact sheet, we will mail it to them again.  
 
 
12. Data and Specimen Banking*  
 
Any data collected by this study may be used for future research. The PI or another approved 
member of the study team will determine who is allowed to access this data. It may include 
collaborators or entities external to UMMS. 
 
ECG and pulse data from all smartphones and watches will be sent to a secure server managed 
by UConn’s information technology services. The data will not be transmitted with participant 
name, DOB, or MRN. The Pulsewatch system will upload data when prompted by participants 
during Aim 3 or by a trained study staff member during the 14-day study visit. This data 
management system is encrypted. Data storage capacity on the Pulsewatch is nearly 14 days at 
the above noted sampling rates for PPG. Thus, pulse data will be safely stored and will be 
retrieved when the Pulsewatch is returned for Aim 2 after 14 days. All ECG and pulse data will 
be password protected and encrypted so that only research personnel can access stored data. 
Once smartwatches are returned, we will have the study coordinator “push” pulse and ECG data 
from the smartwatch and adherence/annotation data from the smartphone. If the smartphone is 
lost, however, we will extract the latest adherence and annotation data and then remotely delete 
the File Store. This protocol protects participants’ confidentiality in addition to the data 
encryption and password protection. We have the programming expertise necessary to carry 
out these operations. 
 
The AliveCor Kardia platform used to store ECG data from the AliveCor ECG system is a 
HIPAA-compliant, HL7 compliant service used by the Cleveland Clinic, UMMMC, and other 
services for clinical grade ECG storage and analysis. This protocol protects participants’ 
confidentiality in addition to the robust means of data encryption and password protection. We 
will upload only ECGs linked to participant IDs. ECGs will be reviewed within 3 days of 
uploading by study staff. The platform will be checked daily on normal business days to observe 
any tracking completed by participants.  
 
The Cardiac Insight patch data will be transferred to the PI via a summary report for review. This 
will be reviewed and stored in a locked, secure space. The data from the Cardiac Insight 

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patches will be de-identified, containing only a participant study ID #. The raw data and digital 
summary reports will be stored on secure UMMS HIPPAA-compliant servers. Similar to the 
watch pulse and ECG data, the Cardiac Insight ECG data will also be uploaded to the same 
secure server managed by UConn’s information technology services. The data will not be 
transmitted with participant name, DOB, or MRN. 
 
Focus group and exit interview recordings, Hack-a-thon materials, and questionnaires (baseline 
and follow-up) will be stored in a digital format (using the nVivo system for audio recordings and 
the RedCAP system for questionnaire data) as well as on paper. All digital data will be 
password protected and encrypted so that only research personnel can access stored data 
using the RedCAP system. All paper questionnaires, consents, etc., will be stored in a locked, 
secure UMMS space.  
 
Screening documents to identify patients to approach for the study will be stored in the Redcap 
File Repository and deleted when we have finished enrolling participants. We will destroy the 
master file of the identifiers of the enrolled participants 5 years after all data analysis is 
completed. De-identified data coded with the Subject ID of participants will be retained 
indefinitely to be reviewed for future publication use. Any paper or physical copies will be stored 
in locked spaces. Audio recordings will be deleted after a research staff member has completed 
the transcription process and quality check process. Transcription will be de-identified, 
protecting confidentiality by replacing participants’ names with study IDs. The master file that 
links the participant to the identifiable information will be in a secure database (RedCAP) and 
only limited research personnel will have access to this information to help protect participants’ 
personal information. Please see our HIPAA Waiver, which is in eIRB. 
 
13. Data analysis and Management* 
 
 
Overall Data Management:  
 
Each participant enrolled in this study will receive a participant ID to ensure that limited personal 
information of our participants is not accessed unnecessarily. Our study team, including the 
study PI, will meet with an independent monitor quarterly to ensure adequacy of human 
subject’s protections, including participant privacy.  
 
For all patient participants, sociodemographic, clinical, laboratory, and medical care information 
will be abstracted from records into a web-based centralized data repository, which was 
developed and is being used in SAGE-AF. As in our prior studies,73 we will abstract data on 
history of TIA/stroke, stroke severity, and clinical variables necessary to derive the 
CHA2DS2VASc (stroke) risk scores.74 We will abstract use of medications (e.g., beta-blockers) 
known to influence vulnerability to AF.74 Data from health records will be imported to our data 
repository as in the SAGE-AF study.73 
 
Data streams will be merged into the Pulsewatch master database that will include audio and 
digital information from focus groups, exit interviews, and questionnaires. AF rhythm status will 
be determined based on ECG data, and summary reports will be stored in the Pulsewatch 
master database utilizing our data system architecture similar to that used in SAGE-AF. Data 
acquisition and quality control processes will be the same. Unique, password-protected, registry 
websites assure consistent staff identification at entry. A data collection manual with coding 

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instructions for each data item in SAGE-AF has been developed and will be updated for 
Pulsewatch.  
 
Questionnaires will be available in a digital format on password protected iPads (using the 
REDCap system) as well as on paper copies. All laptops, desktops, and iPads that we use in 
this study will meet the UMMS encryption policy. All digital data will be password protected and 
encrypted so that only research personnel can access stored data using the REDCap system. 
All paper questionnaires, consents, etc., will be stored in a locked secure UMMS space. ECGs 
will be sent to the AliveCor Kardia Pro platform, a secure provider ECG management system. 
The AliveCor Kardia Pro platform is a HIPAA-compliant, HL7 compliant service used by the 
Cleveland Clinic and other services for clinical grade ECG storage and analysis. This protocol 
protects participants’ confidentiality in addition to the robust means of data encryption and 
password protection. 
  
Cardiac Insight patches have a module chip inside the sensor that stores the data being 
collected over the 14-days. Participants will be asked to bring back both patches at the end of 
the 14-day monitoring period to collect those modules for data collection. A trained study staff 
will remove the modules and place them into the Cardiac insight smart cable to be uploaded to 
a UMass Medical School server. The module will be labeled with the participants ID # and 
stored in a locked cabinet. The report will be read by a blinded Cardiologist for review. Details 
about the Cardiac Insight system can be found in the FDA approved Letter in eIRB (K162503 
Cardiac Insight FDA) for the IRB to review. Similar to the watch pulse and ECG data, the 
Cardiac Insight ECG data will be uploaded to the same secure server managed by UConn’s 
information technology services. The data will not be transmitted with participant name, DOB, or 
MRN. 
 
Smartwatch Data:  
We will reduce the potential for false positive 
AF detection from corrupted (MNA) or low 
amplitude (poor contact) PPG data using 
two methods. First, the Pulsewatch app will 
send a message to participants to remain 
still and perform a 30-sec ECG self-check 
(wrist electrode, high accuracy) should they 
have an AF episode detected. The second 
approach involves the cancellation of 
cyclical frequencies, seen in accelerometer 
data, from the PPG signal. This approach 
was recently developed in our lab and 
should allow us to use segments such as 
shown.23,24 We demonstrate this MN 
correction performance via a representative 
result from offline analysis of raw Samsung 
watch data.(Looking at the figure above, the top panel of shows the comparison of our MN correction 
algorithm (green line) on raw data vs. Samsung’s own embedded motion artifact correction algorithm (brown 
line). The black line is the reference heart rate from a 5-lead ECG. The bottom panel shows the raw PPG 
data recorded from the Samsung watch, and note MN artifacts starting at 100 seconds. The data were 
recorded during treadmill exercise (first 300 seconds), followed by 30 seconds of cool down, as well as with 
arm movements (up and down and shaking) on the side of the smartwatch. Despite the severity of the MN 
artifact, the estimated heart rates calculated by our algorithm closely follow the reference (black line) heart 

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rates. Thus, these 2 approaches can be effectively used to recover some data segments contaminated by 
MNA or by poor signal quality and correctly identify the presence or absence of AF. Once MN artifacts have 
been corrected, we will look at patterns to analyze pulse waveforms for AF detection, including discrimination 
of PVCs and PACs. The MNA and AF algorithms will be embedded using Samsung’s Vobio API. Based on 
our pilot, we estimate 50% usable data during active periods and 90% during rest. The majority of the user's 
day will be at rest (sitting or sleeping), as older stroke patients typically perform limited exercise. 
 
To fine tune and maximize the accuracy of our MNA algorithm, we will use data collected on AF subjects 
(Aims 2 and 3) using the Pulsewatch system. We will compare the performance of our MNA algorithm using 
the Pulsewatch signal to the simultaneous gold-standard Cardiac Insight patch. The data analysis and 
statistical evaluations will be similar to our recently published article on our MNA detection/reconstruction 
algorithm,25,77 but will also involve calculation of absolute error of the estimated heart rate via our algorithm to 
the reference Holter ECG-derived heart rate. Moreover, we will calculate sensitivity, specificity and accuracy 
of AF detection using our algorithm when compared to Cardiac Insight patch data. 
 
AF Detection Analysis:  
 
Analysis for the study focus on the performance of daily wear of the Pulsewatch system for 9 
hours compared to standard Cardiac Insight patch monitoring over the course of 14 days. We 
will examine the system’s accuracy for pAF identification as well as estimation of AF burden. A 
participant will be classified as having pAF or not at the end of the 14-day monitoring period 
based on the gold standard monitor. Data from the Pulsewatch is divided into 30-second 
segments for analysis and a positive reading will be defined as AF being detected in at least 7 
out of 10 continuous data windows (5 minutes). The total number of positive readings collected 
over 14 days from Pulsewatch will be used as the independent variable in a logistic regression 
to predict the binary outcome of pAF (yes vs. no). The area under the receiver operating 
characteristic (ROC) curve (AUC) will be calculated based on the results from the logistic 
regression to evaluate Pulsewatch performance for pAF screening. From the ROC curve, we 
can identify the cutoff point of total number of positive readings that produces the highest 
sensitivity and specificity combination. 
Preliminary data suggest that Pulsewatch will have sensitivity, specificity and AUC of at least 
.9 to detect pAF. Assuming 115.   
Similar analysis will be conducted using the % of positive readings among all readings 
collected from each participant as the independent variable. The 95% confidence intervals (CI) 
of the AUC will be calculated using formula given by Hanley and McNeil. We will then conduct 
exploratory analyses to examine whether characteristics affect watch performance over 14 
days. For example, we will compare the area under 2 independent ROC curves of female vs. 
male participants (or vision impaired vs. not) using a chi-square test. At the end of 14-days we 
will review the data of 45 participants in Aim 2 intervention and see what % of participants have 
AF. If we see less than 5% of all participants using the devices have AF, we will have an 
adaptive protocol for analysis. We would ask participants to extend their use of the devices for 
an additional 14-days and continue to monitor the participants for potential AF cases. Their 
follow up assessment for participants in Aim 2 of Part II would be at the end of the 28 days if we 
take this approach. 
 
Usability Analysis: 
 
We also aim to examine whether participant characteristics (e.g., demographics, level of 
technology use, cognitive impairment, etc.) affect usability and adherence of the Pulsewatch 
system. Usability will be examined by semi-structured interviews, investigator generated 

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questions regarding user experience, and the System Usability Scale (SUS), a validated 
instrument for perceived system usability. Investigator generated questions will have responses 
in a 5-point Likert-like scale, and ordinal regression will be used to evaluate participant 
characteristics that may be associated with more favorable responses regarding usability of the 
Pulsewatch system. The SUS score ranges between 10 and 100, and linear regression will be 
used to examine the participant level factors that are associated with higher SUS scores. 
Logistic regression will also be used to examine whether certain participant factors are 
associated with having a SUS score of over 68, the acceptable cut off being deemed as a highly 
usable system. 
 
Adherence Analysis:  
 
In Aim 3 of Part II of the study, adherence will be operationalized to determine whether pulse 
recordings were present on each day over the 30-day period. We will examine whether 
participant characteristics, e.g., sex, cognitive impairment, or stroke-related quality of life, affect 
the likelihood of adherence over the 1-month study period. We will use a mixed effects logistic 
regression model, including the participant as the random effect to capture the correlation 
among repeated measures from the same participant, using participant characteristics as the 
fixed effects, and a binary indicator of daily adherence as the dependent variable. We will also 
examine the adherence time-trend by including time (day) as a fixed effect in the model and 
participant as a random effect to estimate the slope of adherence over time. To examine 
whether the time trend varies by participant characteristics, we will include the interaction 
between characteristics and time in the model so that the slope of adherence over time can be 
estimated for each category of participant characteristic variables and be compared among the 
categories (e.g., pAF diagnosed vs. no pAF). Secondary analyses will examine rates of 
adherence to Pulsewatch ECG prompts and will compare Pulsewatch users to the usual care 
group with respect to stroke-related quality of life, anxiety, and self-activation. We will calculate 
the change score between baseline and 1 month as a dependent variable. First, a t-test will be 
used to compare 2 study groups on the change score. We will use a linear regression model, 
which will include group indicator (Pulsewatch users vs. usual care) as the independent variable 
and possible confounders (e.g., medication adherence and participant demographics) as 
covariates, to estimate adjusted group differences on the change scores. 
 
 
14. Provisions to Monitor the Data to Ensure the Safety of Subject* 
 
Please review the Data Safety Monitoring Plan (DSMP) in the eIRB for a detailed description 
regarding human subject’s protection.  
 
This plan recognizes the nature of Part II of this study as a clinical trial and this Part involves 
more intensive data safety monitoring, including involvement of an independent monitor, Dr. 
Steven Lubitz. The plan has been reviewed and approved by the Director of the Quantitative 
Methods Core, Dr. Bruce Barton, who has extensive expertise in the design and conduct of 
clinical trials.  
 
As outlined in the DSMP, we will employ an adverse event reporting system (see DSMP Report 
template in eIRB) that will be reviewed by the PI and the independent data study monitor to 
ensure safety of all enrolled participants. However, we have provided an overview of our 
analysis and management plan herein. For any incidental findings, the PI will review the 
recording of the pulse/ECG data and make a clinical decision; if necessary, the PI then will 

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contact the participant’s treating physician to report the findings and recommend follow-up 
plans.   In the unlikely event of incidental findings during Part I, the PI will be contacted if he is 
not present.  
 
All recruitment and training will be conducted by trained personnel who are certified according to 
our study protocols, which include training in procedures for recruitment in the clinical 
environment. Modeled on the PI’s ongoing studies, medical record review protocol uses “gold 
standard” medical records and requires that each abstractor satisfactorily complete 10 practice 
cases before certification. We will have ongoing data quality control checks via audited 
interviews and medical records abstracted in duplicate for 5% random samples. If error rates 
are too high, we will retrain staff and increase quality control sampling until the rates decline to 
acceptable levels. We will continue our ongoing quality control measures with dynamic range 
and consistency checks, missing data surveillance, and error tracking. 
 
All study participant Pulsewatch ECG recordings (both from the 14-day monitor and individual 
AliveCor ECGs) will be manually reviewed by trained study staff under the direction of the PI. 
Two readers, blinded to the determination of the automated rhythm analysis, will review ECG 
data and code sinus rhythm, AF, or other arrhythmias (e.g., premature atrial beats) using 
standard criteria.6 In cases where there is disagreement with respect to rhythm, the PI will 
review the tracing to obtain consensus. ECG data will be reviewed within 3 days by a study 
cardiologist. If cases of AF are detected on manual review or if a participant calls the study 
hotline to report a new health concern, the research coordinator will notify the participant’s 
primary healthcare provider, cardiologist or neurologist and assist in arranging a follow-up. 
Providers will be given the PI’s contact information to arrange care or to speak with a 
cardiologist familiar with the Pulsewatch protocol. 
 
All of the Cardiac Insight patch monitoring data will be de-identified using alpha-numeric study 
IDs. The ECG data from the cardiac monitor will be uploaded to a secure server (UMMS) and 
downloaded for interpretation. The ECG data from the cardiac monitor will also be uploaded to 
the secure UConn server and downloaded in order for UConn to compare their PPG data from 
the smartwatch to the ECG data from the cardiac monitor. Only Dr. Fitzgibbons and the UMass 
research staff will have access to the code linking the subjects to study IDs. The study 
cardiologists will review any arrhythmias on the cardiac monitoring device for accuracy. If any 
arrhythmias are detected, then Dr. Fitzgibbons will notify the participant’s treating clinician.  
 
We will report any issues to the UMMS IRB in accordance with the Investigator Manual and 
Prompt Reporting Requirements. 
 
We will have independent data safety personnel who will evaluate the process of ECG review 
and reporting as well as any adverse events related or unrelated to study participation. Please 
see resource available section.  
 
The PHQ-9 and GAD-7 in the questionnaire are the only instruments that require monitoring and 
a UMMMC Protocol plan has been submitted with this IRB application. Per our protocol, if study 
staff detect high PHQ-9 and/or GAD-7 scores, they will suggest that participants discuss their 
symptoms of depression and/or anxiety with their doctors and/or the trained personnel at the 
UMMMC Emergency Mental Health hotline (508-334-3562). Study staff will be fully trained to 
note that the checkbox on the cover page of each questionnaire will remind them to follow the 
extreme emotional distress protocol when warranted. 
 

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15. Withdrawal of Subjects without their consent 
Participants, including patients, caregivers and providers, will be able to withdraw from the study 
at any time. Participants will be withdrawn from the proposed study if they are unable or 
unwilling to wear the smartwatch and are found to meet exclusion criteria. At that point, they will 
be informed of why they are being removed from the study and given an opportunity to ask 
questions.  
 
16. Risks to Subjects 
No more than minimal physical risks will be involved with this study. First, use of a smartphone 
or smartwatch does not pose any significant health concerns. Use of a single-lead, FDA-
approved, commercially available ECG device (AliveCor) does not require placing of electrodes 
on the human body and does not pose any physical risk. The Cardiac Insight monitor poses no 
more than minimal risk, but the monitor may cause skin irritation at the site of application. Prior 
to approaching patients, we will be screening to ensure that the patient does not have any 
contraindication to be using the Cardiac Insight patch as listed under exclusion criteria (see 
section 6). This poses no significant risk to participants since this is the standard device used in 
clinical practice.  
 
Another potential but minimal risk to participants is feeling psychologically uncomfortable 
disclosing sensitive information (e.g., depressive symptoms) or performing geriatric 
assessments (e.g., assessments of cognitive function) while answering questions during the 
interview process at baseline/follow up visits. Depressive symptoms will be collected as part of 
the interview and there is the possibility that emotional distress or depression will be identified. 
There is no risk of extreme stress as a result of participants answering these questions. All 
study staff interacting with participants will be trained to detect when a participant is feeling 
uncomfortable and will re-iterate that the participant can stop an interview at any time and can 
refuse to answer any question for any reason.  
 
Another risk to participants will be the possibility of a breach in confidentiality. However, we will 
try our best to protect participants’ confidentiality to minimize the risk (see data safety plan). All 
participant data will be held behind secured firewalls at UMMS.  As noted in Section 12, ECG 
and pulse data from all smartphones and watches, as well as ECG data from the Cardiac 
Insight cardiac monitors, will be sent to a secure server managed by UConn’s information 
technology services. The data will not be transmitted with participant name, DOB, or MRN. 
 
Access to databases will be restricted to only authorized personnel. We will utilize all electronic 
data capture procedures and, therefore, no paper records will be kept long-term. Any paper 
records (such as medical record information) that are needed for the study will be destroyed 
immediately following entry into electronic databases. All consent and other forms that are 
required to be kept will be kept in a locked file cabinet in locked study offices.  
 
17. Potential direct benefit to subjects 
There are no direct benefits to the subjects.  
 
18. Vulnerable populations 
We will not be targeting vulnerable populations; all participant must have capacity to be able to 
consent. Please see the protocol for determination process of capacity to consent. 

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Providers may be seen as a vulnerable population and we will have a protocol in place for 
recruiting them to minimize the potential for undue influence. Please, refer to section 24. Local 
Recruitment Methods to review this protocol. 
 
19. Multi-site research 
NA. Not a multi-site study  
 
20. COMMUNITY-BASED PARTICIPATORY RESEARCH* 
NA. This study is not a community-based research.  
 
21. SHARING OF RESEARCH RESULTS WITH SUBJECTS* 
Study results will not be directly shared with participants unless a rhythm abnormality is 
diagnosed based on their AliveCor ECG or Cardiac Insight patch monitor results. See section 
11. Procedures involved (Part II, specifically) for the protocol involving the PI having to contact a 
participant or participant’s clinician about an abnormal rhythm when detected.  
 
22. SETTING 
Research assistants will enroll participants with a history of stroke and/or TIA from among those 
presenting for a clinic visit or to the inpatient service or who have a CHA2DS2-VASc score > 3. 
Embedding this project in the UMMMC neurology and cardiology inpatient and ambulatory 
clinics will facilitate recruitment.78 In the stroke clinic alone, four neurologists see over 500 
patients with cryptogenic stroke/TIA yearly. Dr. Majaz Moonis (Co-I) has had high success 
conducting research within this clinic.  
 
We will also enroll up to 10 UMMMC providers (half cardiologists or neurologists, half 
nurses/nurse practitioners) with experience treating patients with cryptogenic stroke who need 
AF monitoring. 
 
We will be holding focus groups in a comfortable conference room at UMMS. Any 
questionnaires, exams, interviews or study appointments will be completed in a private, 
comfortable room in the UMMS Clinical Trials Center located in the ACC Building. If this center 
is not available, we will have another private and comfortable area for participants to complete 
all study protocols here at the UMMS University campus.  
 
During COVID-19 restrictions, questionnaires and study appointments will be completed via a 
phone call or a secure teleconferencing system, like Zoom, whichever is more convenient for 
the participant.  
 
 
23. RESOURCES AVAILABLE 
The study will be led by investigators with extensive experience working with stroke and AF 
patients.  All neurologists/cardiologists, and research coordinators/staff will ensure that 
regulatory paperwork, such as consent forms and patient confidentiality, are used appropriately.  
 
All recruitment and training will be conducted by trained personnel who are certified according to 
our study protocols, which include procedures for recruiting study participants in the clinical 
environment. Modeled on the PI’s ongoing studies, our medical records review protocol uses 
“gold standard” medical records review methods, and requires each abstractor to satisfactorily 
complete 10 practice cases before certification. We will have ongoing data quality control 
checks via audited interviews and medical records abstracted in duplicate for 5% random 

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samples. If error rates are too high, we will retrain staff and increase quality control sampling 
until errors decline to an acceptable level. We will continue our ongoing quality control 
measures with dynamic range and consistency checks, missing data surveillance, and error 
tracking.  
 
Rhythm diagnoses will be determined based on self-initiated or auto-triggered ECG tracings 
from the gold-standard Cardiac Insight patch monitor. Two readers, blinded to the determination 
of the automated rhythm analysis, will review all time-stamped monitor recordings and code 
sinus rhythm, AF, or other arrhythmias using standard criteria. In cases where there is 
disagreement between the 2 primary interpreting cardiologists with respect to rhythm, a 3rd 
physician will review the tracing to obtain consensus. 
 
Personnel Resources are as follows:  
• 
The PI: Will be responsible for the direct efforts of the research project and meeting with 
research coordinators/mangers weekly during the study period. In addition, the PI will 
adjudicate ECG recordings and, if arrhythmias are detected, will notify the participants’ 
treating clinicians.  
  
• 
Co-I’s: Will provide study management, quality assurance, staff oversight, study 
progress, diagnostic adjudication, data presentation, and preparation of quarterly and 
annual progress reports.  The Co-Is will be available after hours to support research 
coordinators. 
 
• 
Project Manager: This individual will not be primarily responsible for study enrollment, 
but will instead take an administrative role and have prior experience managing research 
staff and overseeing day to day operations and enrollment activities of this research 
project. She will supervise study progress (enrollment, chart reviews, etc.), maintain 
records of such progress, and communicate any concerns with the Co-PI’s.  She will 
arrange regular meetings with the Co-PI’s and the research staff. 
 
• 
Research Coordinators: These individuals will be required to have at least an 
associate’s degree and 6 months of either clinical research or patient care experience as 
they will be responsible for direct participant enrollment/consent and assisting with chart 
reviews. They will have completed their CITI certification. They will be trained by the PI’s 
and/or project manager to learn the medical terminology, chart review methodologies, 
enrollment protocols, and how to interact with clinical staff. In addition, they will also be 
trained to enter clinical data into a custom REDCap database. The coordinators will be 
responsible for contacting any potential provider participants and recruiting them.  
 
• 
Biostatistician: There is a budgeted position for a statistician to work on this project. 
This individual will be responsible for reviewing the study’s data calculations and power 
calculations that are needed to achieve the goal of this study.   
 
• 
Research Staff/Research Assistants (RA): We will develop a manual of operations 
(MOO) for this study and require that all staff are familiar with this study. We will train all 
staff on enrollment procedures and will observe 3 enrollments prior to having them work 
independently to approach patients. The RAs will also be responsible for assuring the 
proper protocol is followed for the audio recordings obtained in any focus 
group/interview.  
 

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• 
Educating Clinical staff: The study protocol will be vetted with attending 
neurology/cardiology physicians and staff (residents, nurses, and MD faculty) in several 
ways. As part of our monthly faculty meetings, the PI will present the study to faculty and 
provide study updates and opportunities to ask questions. 
 
• 
Independent Data Monitor: This person will be responsible for reviewing smartwatch 
adherence data. The monitor will be an independent party who is not from UMMS, who 
is classified as non-investigator personnel, and who is familiar with the data safety 
monitoring plan.  
 
• 
Engineers and app programmers: Will be present at the Hack-a-thon event to work 
with patients and providers on implementing real time edits to the app as suggestions 
are mentioned throughout the event. The UConn team has ceded to UMass IRB in order 
to be able to participate in research activities with UMMMC patient participants.  
 
 
If study staff who have primary affiliations outside of UMMS will interact with subjects or access 
private identifiable information about them, they will either obtain their own IRB approval or we 
will work with the UMMS IRB to establish a reliance agreement for UMMS to serve as the 
Reviewing IRB. Collaborators from UConn and Northeastern University have already completed 
this paperwork.  
 
24. Local Recruitment Methods 
 
Part I: Trained research assistants (RAs) will screen the UMMMC neurology and cardiology 
rosters for patients, then will send introductory letters to eligible patients who meet inclusion 
criteria and are free of any exclusion criteria. Letters of introduction to the study (Patient FG 
Invitation in eIRB submission) will be sent to eligible patients 5-7 days before their scheduled 
clinic visits with an opt-out phone number for patients who do not wish to be approached for 
study participation. Dr. Keaney, Chief, Cardiovascular Medicine, will sign this letter. RAs will 
approach patients in the UMMMC out-patient clinics. If patients are interested and deemed 
capable (using the capacity assessment), then they may be enrolled in the study by signing the 
IRB-approved informed consent form. Caregivers who accompany a loved one to clinic will also 
be approached for consent to participate in focus groups. Before approaching patients and their 
caregivers, RAs and study personnel will be trained on how to explain all of the study’s components to 
potential participants.  
 
We will give the Hack-a-thon Fact Sheet (see Fact Sheet: Patient and Provider Hack-a-thon in eIRB 
submission) to all focus group participants. We will also ask participants at the focus groups to fill out a form 
to indicate if they would like to be contacted about participating in the Hack-a-thon (see Hack-a-thon Contact 
Info sheet in our eIRB submission). A study staff member will call participants who indicate they are 
interested in participating in the Hack-a-thon, and to disclose that participants have the right to opt-out of this 
event.  
 
Ten providers will be identified from the UMMMC neurology and cardiology groups for focus 
group or interview participation. We will approach physicians and advanced care nurses via 
email or telephone (see Provider email and telephone invitation script with this IRB submission). 
Providers will be given an IRB-approved Fact Sheet (in eIRB submission). The study 
coordinator, not the PI or Co-Is, will recruit providers affiliated with UMMMC to minimize the 

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potential for undue influence. The study coordinator will explain to providers that their decision 
to participate or to not participate in the study will not affect their employment status at UMMMC.  
 
Part II: We will use a rolling enrollment and randomization design with a goal of 90 participants 
completing the Aim 2 intervention and 30 participants completing the Aim 2 control group 
procedures (up to n=120 in the trial). To enroll patients who are admitted to UMMMC, RAs with 
access to the UMMMC neurology inpatient roster and cardiology/neurology ambulatory clinic 
schedules will screen the rosters daily to identify potentially eligible patients. We will screen any 
patient admitted with stroke or TIA to the neurology service (identified from the inpatient 
neurology roster admitting diagnosis) or presenting with a complaint potentially related to stroke 
(e.g., facial droop) and evaluated by the stroke service. For potentially eligible participants in 
whom the diagnosis of stroke/TIA is suspected (e.g., focal weakness), but not yet listed as a 
diagnosis, a neurology consultation note or history and physical examination documenting 
stroke/TIA will be needed to confirm eligibility. We will also screen  cardiology patient rosters for 
any ambulatory patients who could have a CHA2DS2-VASc score > 3 by looking at their medical 
problem list or provider notes.  
 
Patients who are admitted to the neurology/cardiology units at UMMMC will be considered 
eligible to participate if they meet all of our inclusion criteria and are free of exclusion criteria. 
They will be approached by the study staff before they are discharged from their inpatient stay. 
The study staff will approach the patient’s clinical team prior to entering the patient’s hospital 
room for approval to approach the patient for this study. Study staff will present information to 
the patient about the study, including the randomization process, and will perform an 
assessment of the patient’s capacity for informed consent. Study staff will demonstrate the 
features of the Cardiac Insight monitor, smartwatch, and smartphone/app and then allow the 
patient to ask questions about the devices. We will involve family who are present in the 
patient’s room to answer their questions about the study. Patients will be given the opportunity 
to consider participating in the study until their day of discharge from the hospital. If the patient 
consents to participate, study staff will administer the baseline questionnaire. Study staff will 
also place the cardiac monitor on the participant’s chest by following the Cardea Solo Quick 
Start Guide (submitted to eIRB). We are not altering usual care, and the devices should not be 
uncomfortable to wear. The participant will be given guidance on how to use the devices and 
the process for baseline compensation. We anticipate the explanation of the study and consent 
procedure in the inpatient cohort will take ≤ 30 minutes. 
 
Research assistants will also screen ambulatory patients with a history of stroke or TIA in their 
problem list or medical history. For ambulatory patients, letters of introduction to the study will 
be sent to eligible patients 5-7 days before their scheduled clinic visit with an opt-out phone 
number for patients who do not wish to be approached for study participation. We have 
successfully used a similar approach in other studies. This invitation letter is enclosed in our 
application packet. 
 
The consent will include permission for follow-up contacts and medical record review, and will 
also request access to identified proxies, who would be able to help us contact patients in the 
event they change practices and do not follow up at UMMMC. We will offer modest incentives 
for recruitment and retention in Pulsewatch: T-shirts and/or bags and/or pens with Pulsewatch 
logos offered at recruitment and mailed during follow-up.  
 
All participants will be brought back for a study visit approximately 14 days after enrollment. This 
visit will take place in a research area that is private and comfortable. There, participants will 

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return both of their patch monitors, smartwatch, and smartphone, and will complete a 
questionnaire. From the 120 participants in both the Aim 2 intervention and control groups, we 
will randomly select up to 60 participants to be offered an opportunity to self-monitor at home 
using the Pulsewatch smartwatch/smartphone for 30 days, as well as the AliveCor ECG 
recording device. The 60 participants who are randomized into the control arm of Aim 3 will not 
be offered the opportunity to self-monitor with any device. At the completion of the 30 days, 
participants in Aim 3’s intervention group can either return for a follow-up visit to return all 
equipment and complete the 44-day follow-up questionnaire, or can return their devices through 
a prepaid package and complete the 44-day follow-up questionnaire over the phone. 
Participants in Aim 3’s control group will have a choice to complete their 44-day follow-up 
questionnaire either in person or over the phone. All participants coming back for an exit 
interview in Part II of the study will be sent a Fact Sheet reviewing all the details of the process 
(Fact Sheet: Part II Exit Interviews in eIRB submission). Upon receipt of the study equipment 
and/or the 44-day questionnaire, the study team will compensate the participants. 
 
Compensation will be given as an incentive. All patients and caregivers who participate will be 
compensated for their time and efforts in the study as shown in the table below. Providers will 
not be compensated for participating.  
Participant Sub-groups 
Compensation 
Amount 
Time Earned 
Part I: Focus Group 
$60.00 gift card 
After completing the focus group 
Care-givers  
$60.00 gift card 
After completing the focus group 
Part I: Hack-a-thon 
$15/hour gift card 
After completing the Hack-a-thon event 
Aim 2: Control group 
$100.00 gift card 
After completing the baseline interview 
$100.00 gift card 
After completing the 14-day follow-up visit 
Aim 2: Intervention group 
$100.00 gift card 
After completing the baseline interview 
$100.00 gift card 
After completing the 14-day follow-up visit 
$60.00 gift card 
Participants who complete exit interviews 
in Part II 
Aim 3: Control group 
$50.00 gift card 
After completing the 44-day follow-up 
questionnaire 
Aim 3: Intervention group 
$50.00 gift card 
After returning the study devices and 
completing the 44-day follow-up 
questionnaire 
 
 
Before the focus groups or the Hack-a-thon are held, we will inform all participants that they will 
receive parking passes if they park in the Visitor Parking Lot to attend these events. Valet 
parking uses a different voucher that our study is not purchasing at this time.  
 
To help with participant retention, the study team may contact participants by phone or mail to 
remind them of upcoming visits or to check in and see how participants are doing, particularly in 
Part II. The study team may also contact participants by phone or mail if it implements the 
adaptive design (due to low rates of AF) in which participants are asked to extend wearing the 
devices for longer than the initial 14-days. Any letters will be submitted to the IRB as a 
Modification for review and approval prior to use. 
 
COVID-19 Modified Local Recruitment Methods 
During COVID-19 restrictions, we will screen both the cardiology and neurology ambulatory care 
clinics to identify eligible patients. When eligible patients are identified, they will be sent our 

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COVID-19 modified patient invitation letter 7-14 days prior to their scheduled appointment. As 
with our normal, IRB-approved patient invitation letter, there will be a number listed for the 
patient to opt-out of being contacted for the study. A day prior to their scheduled appointment, a 
study team member will contact the potential participant to assess interest in the study. If the 
potential participant agrees to participate, we will follow the consent and enrollment procedures 
outlined in Section 11: Procedures Involved. 
 
 
25. LOCAL NUMBER OF SUBJECTS 
 
There will be a total of up to 170 participants in this study.  
Part I: Up to 40 out-patient stroke participants or caregivers and 10 providers.  
Part II: Up to 120 participants, including 30 in the Aim 2 control group and 90 in the Aim 2 
intervention group.  Of the 120 participants in both the Aim 2 intervention and control groups, 60 
will be invited to participate in the intervention arm of Aim 3 and use the devices for 30 days. At 
the 14-day follow-up visit, the other 60 participants randomized into the control arm of Aim 3 will 
be invited to complete a questionnaire in person or over the phone at the end of 30 days. 
 
In order to obtain 170 participants who complete the research, we may over enroll or replace 
participants who drop out. 
 
Adaptive enrollment design (Part 2): If we struggle to identify sufficient numbers of eligible 
participants from the inpatient stroke service or clinics over the first 6 months of enrollment 
(<50% targeted enrollment), we will employ an adaptive design and approach patients 
presenting to UMMMC out-patient and in-patient cardiology and/or neurology clinics who have 
high risk for atrial fibrillation and stroke on the basis of a CHADSVASC score >=2. Furthermore,  
If we struggle to enroll a sufficient number of participants from the UMMS University campus, 
we will recruit at the stroke treatment centers at UMass Memorial - Health Alliance Hospital in 
Leominster, MA, and at UMass Memorial - Marlborough Hospital in Marlborough, MA. The PI 
has actively sought approval from these sites to approach patients from these locations in order 
to meet study enrollment goals.   
 
 
26. CONFIDENTIALITY  
Trained RAs will use Subject IDs for all the data collected from participants to limit the use of the 
participants’ personal information. Information will be collected via the UMass EHR system for 
screening and basic demographic information. The data collected at the focus groups/exit 
interviews will be recorded but then transcribed later and the recording will be deleted. Please 
refer to section 13 for more details regarding confidentiality of data and management.   
The audio recordings of the focus groups/exit interviews will be deleted after the recording has 
been transcribed and checked for quality. The transcription will be kept in the secure database 
of REDCap.  
 
 
27. PROVISIONS TO PROTECT THE PRIVACY INTERESTS OF SUBJECTS 
All PIs and research assistants/coordinators will complete CITI training to understand the 
necessary measures to protect personal identifiers and reinforce the importance of sound ethics 
in conducting this research study. The study team will also search for the best and most private 
setting in the UMMMC environment to help participants feel at ease with the study and explain 
that their information will be protected. Participants will also be told they have the right to refuse 

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to answer any questions they feel uncomfortable answering or/and the right to refuse to be in 
this study.  
 
a. PI - Will have ongoing access to REDCap clinical data for data integrity and  
Q/A checks. 
b. RAs/Research coordinators will have access only to EHR data, and study data they are 
entering into REDCap.  
c. We will request a waiver of HIPAA authorization in order to do preliminary EHR and 
clinical record searches to determine if patients are eligible for study enrollment based 
on our inclusion and exclusion criteria. A signed HIPAA form will be obtained once a 
patient is enrolled and able to sign the form. 
d. A biostatistician/database manager will be given access to clinical data that does not 
readily identify subjects by name for data analysis. 
e. Independent monitor will review deidentified safety, adverse events, and study reports 
(see DSMP) 
 
28. COMPENSATION FOR RESEARCH-RELATED INJURY 
This study involves research procedures that are considered minimal risk; no funds have been 
set aside. 
 
29. ECONOMIC BURDEN TO SUBJECTS 
There is no economic burden to subjects because of participating in this research. Study funds 
will be providing all of the devices at no cost to participants.  
 
30. CONSENT PROCESS 
Prior to enrolling participants, the study team will have a training session. This training session 
will focus on all study aspects but particularly to ensure that all study staff are familiar with and 
will follow HRP-802 INVESTIGATOR GUIDANCE: Informed consent. We will be obtaining IRB-
approved informed consent and HIPAA authorizations from all patients who are participants in 
Part I and Part II of this study. Participants who are caregivers and providers will receive a fact 
sheet instead of signing an informed consent form - this recommendation for the IRB is because 
the study team does not need any health record information from these participants to take part 
in our study procedures.  
 
It is important to obtain HIPAA authorization from the patients who become participants in order 
for the study team to have access to certain aspects of their EHR. Information such as 
demographics (age and sex), related medical information like family history, current and past 
medications or therapies, and information from physical examinations will help the team 
understand the type of population in this study. For example, medical notes on physical exams 
can describe how much patients may be able to move their arms; this will help us assess if we 
should approach patients who have very limited arm movement since our study asks 
participants to wear a watch. In addition, this information will help us capture the severity of our 
participants’ physical and medical limitations. We will also need this information for patient 
participants in the focus groups because we would like to be able to compare these participants 
to the Part II participants who will be using the Pulsewatch System.  
 
After RAs identify a potential participant and explain the study, RAs will ask the potential patient 
participant to read, sign, and date the consent form. If a caregiver is present, then a fact sheet 
may be given to them regarding more information about participating in the focus groups. If 
patients or caregivers want more time to decide whether to participate in the study, RAs will 

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provide them with the study phone number (774-455-3799) on which they can call us. Part I and 
Part II of the study will have a separate consent form because each part requires different types 
of participation. In part I, we will have a consent form for eligible patients to participate in the 
focus groups.  
 
The research coordinator will be responsible for contacting providers who have expressed 
interest in this study. The coordinator will inform all potential provider participants that this study 
is completely voluntary and will not affect their status as employees of UMMMC or UMMS. If 
providers wish to opt-out, they may directly contact that study team and/or coordinator.  
 
In Part II, we will have one consent form that outlines the randomization trial method and what 
patients will be required to do to participate in the study.  
We will only use IRB-approved stamped consent forms.  
 
During COVID-19 restrictions, since we will not be meeting the patients in person to obtain their 
informed consent form and HIPAA authorization signature, we will instead send them a COVID-
19 specific informed consent form. This form will be extensively reviewed with the patient over 
the phone to obtain their informed consent, and their acknowledgement to disclose protected 
health information. 
 
31. PROCESS TO DOCUMENT CONSENT IN WRITING 
Written informed consent will be given to participants who are patients (not caregivers or 
providers, who will receive a Fact Sheet). All study staff members who a part of this study will be 
trained properly and have a complete understanding of all study related documentation in order 
to help answer any questions participants may have. The approaching staff member will assess 
the capacity of the patients to consent; we have submitted to the IRB a “Capacity for Informed 
Consent” form that can be used. We anticipate that due to the study selection criteria (older 
patients), some patients will not be able to provide informed consent. Thus, all patients will be 
assessed for their understanding of the study, the risks and benefits associated with the study, 
the voluntary nature of participation, and the confidential nature of all study data. If patients 
answer 3 or more questions out of 8 incorrectly, they will be deemed unable to provide informed 
consent and excluded. Safeguards will be put into place to protect the rights of cognitively 
impaired participants. 
For caregivers and providers, we will obtain informed consent via an unsigned fact sheet given 
to them prior to study visits.  
All participants who sign the consent form will be given a copy to keep for their own records. 
The study team will keep the original copy of the signed consent forms in a locked cabinet in a 
locked room. The study team will also make another copy and send it to UMMMC Medical 
records to be kept on file for each patient who participates in the research.  
 
Please see Section #30: Consent Process for information regarding consenting patients during 
COVID-19 restrictions. 
 
To minimize patient burden during this time, we are requesting a waiver of documentation of 
written consent for subjects. We attest that all of the following are true: 
• 
The research involves no more than minimal risk to the subjects. 
• 
The research involves no procedures for which written consent is normally required 
outside of the research context, and all study activities are conducted over the telephone 
or Zoom. 

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• 
Subjects will be provided a written statement including the elements of consent 
(described on the COVID Informed Consent Form). 
 
32. DRUGS OR DEVICES 
This study will use only commercially available devices (Samsung gear, Android smartphones) 
or FDA approved devices (AliveCor Kardia Mobile device and app). Part II participants will use 
the AliveCor Kardia Mobile devices and smartphones that will only run the AliveCor app (FDA 
approved for single-lead ECG recording) and the Pulsewatch app. A gold-standard, 
commercially available (Cardiac Insight Cardea Solo) monitoring technology will be deployed 
and used by all Part II participants. We have enclosed a copy of the FDA approval letter for both 
AliveCor and Cardiac Insight into this submission. In addition, we have also enclosed a copy of 
detailed information regarding these devices for any review.  
 
The mobile device application (Pulsewatch App) that will be developed in this study at the end 
of Part I is not commercially available nor FDA approved. This application (Abbreviated IDE) is 
only to be used with participants of this study. For this reason, we would like to document the 
following: 
 
 
 
 
 
 
 
 
 
 
i. The device is not a banned device; 
ii. The device is not intended as an implant that presents a potential for 
serious risk to the health, safety, or welfare of a subject; 
iii. The device is not purported or represented to be for a use in supporting or 
sustaining human life that presents a potential for serious risk to the 
health, safety, or welfare of a subject; 
iv. The device is not for a use of substantial importance in diagnosing, curing, 
mitigating, or treating disease, or otherwise preventing impairment of 
human health that presents a potential for serious risk to the health, safety, 
or welfare of a subject; and 
v. The device does not otherwise present a potential for serious risk to the 
health, safety, or welfare of a subject. 
vi. The device will be labeled in accordance with 21 CFR 812.5. 
vii. The PI as sponsor will 
1. Comply with the requirements of 21 CFR 812.46 with respect to 
monitoring investigations 
2. Maintain the records required under 21 CFR 812.140(b) (4) and (5) 
and make the reports required under 21 CFR 812.150(b) (1) 
through (3) and (5) through (10) 
3. Ensure that participating investigators maintain the records 
required by 21 CFR 812.140(a)(3)(i) and make the reports required 
under 21 CFR 812.150(a) (1), (2), (5), and (7) 
4. Comply with the prohibitions in 21 CFR 812.7 against promotion and other 
practices 

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