Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke

Smartwatch Monitoring for Atrial Fibrillation After Stroke

The goal of this research study is to develop a smartphone application capable of monitoring paroxysmal atrial fibrillation (pAF) in people who have survived a stroke or transient ischemic attack (TIA) or people who are at risk for a stroke and are age 50 and older. The study team plans to develop a highly effective and easy to use cardiovascular surveillance system to monitor patients for pAF on a nearly continuous basis. People involved in the development of this system include patients, their caregivers, health care providers, and computer programmers.

Study Overview

• Status: Completed
• Conditions: Stroke; Atrial Fibrillation
• Intervention / Treatment: Device: Testing Devices; Device: Cardea Solo by Cardiac Insight; Device: Kardia Mobile by AliveCor

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • UMass Chan Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• History of Transient Ischemic Attack (TIA) or stroke or at risk for stroke based on a CHA2DS2-VASc score equal to or greater to a score of 3, presenting at the UMass Memorial Medical Center (UMMMC) inpatient service or ambulatory clinic (neurology clinics and cardiovascular clinics included)
• Age: greater to or equal to 50 years of age
• Able to sign informed consent
• Willing to participant in a focus groups and/or Hack-a-thon for Aim 1 participants only
• Willing 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 for Aims 2 and 3 participants only

Exclusion Criteria:

• Major contraindication to anti-coagulation treatment
• Plans to move our of the area over the 44-day follow up period
• 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
• Known allergies or hypersensitivities to medical grade hydrocolloid adhesives or hydrogel
• Patient with life threatening arrhythmia's who require in-patient monitoring for immediate analysis
• Patient with implantable pacemaker as paced beats interfere with ECG readings
• 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
• Major contraindication to anti-coagulation treatment (i.e., major hemorrhagic stroke)
• Individuals who are not yet adults
• Pregnant women
• Prisoners

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Testing devices plus Cardea Solo device by Cardiac Insight for 14-day period.	Device: Testing Devices; Pulsewatch system testing application on smartphone with smartwatch.; Device: Cardea Solo by Cardiac Insight; Gold-standard cardiac monitor for comparison of testing devices.
Active Comparator: Control Group; Only Cardea Solo device by Cardiac Insight for 14-day period.	Device: Cardea Solo by Cardiac Insight; Gold-standard cardiac monitor for comparison of testing devices.
Experimental: Intervention Group for Extended Use; 30-additional days of extended use of testing devices for adherence plus Kardia Mobile ECG device by AliveCor.	Device: Testing Devices; Pulsewatch system testing application on smartphone with smartwatch.; Device: Kardia Mobile by AliveCor; Mobile ECG device for comparison of testing devices during the extended use period.
No Intervention: Control Group for Extended Use; No device usage for 30-days following completion of the original 14-day period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability of Pulsewatch System (System Usability Scale & Rating Scale) at 14 Days Post the First Randomization	System usability scale, self-reported, of likes, dislikes, and problems encountered with the smartphone application and smartwatch. Each item regarding likes and dislikes will be scored 1-5 (1= strongly disagree; 5= strongly agree or Didn't use). Problem encountered will be scored with yes or no options with space provided for explanations. Also, using Mobile Application Rating Scale (MARS) App Classification questions will capture the participants' experience with the application. Each MARS item uses a 5-point scale (1=inadequate, 2=poor, 3=acceptable, 4=Good, 5=Excellent) and sub-scales will have an average mean to indicate the overall rating of the application. Number of participants with SUS > 68 was reported in the Outcome Measure Data Table	Assessed 14 days post the first randomization
The Number of Participants With Atrial Fibrillation Detected by Smartwatch at the 14 Day Trial Period	This outcome was measured by the number of atrial fibrillation episodes identified by the smartwatch biosensors. This was conducted using two approaches. Firstly, the Pulsewatch app sent 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 involved the cancellation of cyclical frequencies, seen in accelerometer data, from the photoplethysmogram (PPG) signal. Thus, these two approaches were effectively used to recover some data segments contaminated by MNA or by poor signal quality and correctly identified the presence or absence of AF. Once MN artifacts were corrected, we looked at patterns to analyze pulse waveforms for AF detection, including discrimination of PVCs and PACs	Assessed throughout 14 day trial period
The Number of Participants With Detection of Atrial Fibrillation by a Patch Monitor (Confirmed by Cardiologist Overread) at 14 Days Post the First Randomization.	Episodes of atrial fibrillation was identified by the gold-standard monitor (Cardea Solo by Cardiac Insight). The Cardiac Insight patches have a module chip inside the sensor that stores the data being collected over the 14-days. After the participants returned the patches at the end of the 14-day monitoring period, a trained study staff removed the modules and placed them into the Cardiac insight smart cable to be uploaded to a UMass Medical School server. The ECG readings are then read by a board-certified cardiologist to confirm true atrial fibrillation detection.	Assessed at 14 days post the first randomization.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Anxiety Symptoms at Baseline and at the Last Study Visit 30 Days Post the Second Randomization.	Anxiety will be assessed using the Generalized Anxiety Disorder-7 scale (GAD-7), a revised version of the anxiety module from the Patient Health Questionnaire, which consists of Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for generalized anxiety disorder over the past 2 weeks. 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. This change in outcome was between baseline and the last study visit 30 days post the second randomization.	Assessed at baseline and at the last study visit 30 days post the second randomization (44 days)
Change in General Health MCS at Baseline and at the Last Study Visit 30 Days Post the Second Randomization (44 Days)	The Short Form (SF-12) health survey to assess health related quality of life, this validated instrument domains include general health questions and mental health related questions. Scores range from 0 to 100, where higher scores indicate higher level of health. This change in outcome was between baseline and the last study visit 30 days post the second randomization (44 days).	Assessed at baseline and at the last study visit 30 days post the second randomization (44 days)
Change in General Health PCS at Baseline and at the Last Study Visit 30 Days Post the Second Randomization (44 Days)	The Short Form (SF-12) health survey to assess health related quality of life, this validated instrument domains include general health questions and physical health-related questions. Scores range from 0 to 100, where higher scores indicate a higher level of health. This outcome was assessed at baseline and at the last study visit 30 days post the second randomization (44 days).	Assessed at baseline and at the last study visit 30 days post the second randomization (44 days)
Change in Disease Management Self-Efficacy (The General Disease Management Scale) at Baseline and 14 Days Post the First Randomization	Self-efficacy for disease management is associated with engagement in health behaviors and with improved medication adherence. The General Disease Management scale is a 5-item scale assessing confidence in disease self-management (scores 0-50, higher scores = greater confidence, lower scores = lower confidence). This change in outcome was between baseline and 14 days post the first randomization.	Assessed at baseline and 14 days post the first randomization
Change in Symptom Management Self-Efficacy at Baseline and 14 Days Post Randomization	Self-efficacy for disease management is associated with engagement in health behaviors and with improved medication adherence. The Symptom Management scale is a 5-item scale assessing confidence in managing chronic disease symptoms (items tailored to the sample), with scores ranging from 0 to 100. A higher symptom management score indicates a higher confidence in managing symptoms. Conversely, a lower score indicates a lower confidence in managing symptoms. This change in outcome was between baseline and 14 days post randomization.	Assessed at baseline and 14 days post randomization
Change in Patient Activation Score at Baseline and at the Last Study Visit 30 Days Post the Second Randomization (44 Days)	Patient activation refers to a patient's ability and willingness to manage their health. Activation will be measured using the 10-item Consumer Health Activation Index (CHAI). Scores range from 10 to 60. A higher score indicates that the patient has higher activation for self-management of their condition. Conversely, a lower score indicates lower activation for self-management of their condition. This change in outcome was between the baseline and the last study visit 30 days post the second randomization (44 days)	Assessed at baseline and at the last study visit 30 days post the second randomization (44 days)
Change in Medication Adherence at Baseline and 14 Days Post the First Randomization	Medication adherence will be measured using the 12-item Adherence to Refills and Medications Scale (ARMS), a well-validated measure of patient-reported adherence. The minimum to maximum ARMS score ranges from 1 to 4. Higher scores indicate poorer adherence, and lower scores indicate better medication adherence. This change in outcome was between baseline and 14 days post the first randomization.	Assessed at baseline and 14 days post the first randomization

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Brigham and Women's Hospital; University of Connecticut; Northeastern University
• Investigators: Principal Investigator: Timothy Fitzgibbons, MD, PhD, UMass Medical School

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2019
• Primary Completion (Actual): September 20, 2021
• Study Completion (Actual): September 20, 2021

Study Registration Dates

• First Submitted: November 29, 2018
• First Submitted That Met QC Criteria: November 30, 2018
• First Posted (Actual): December 3, 2018

Study Record Updates

• Last Update Posted (Actual): November 18, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Cardiac Arrhythmias
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arrhythmias, Cardiac; Stroke; Atrial Fibrillation
• Other Study ID Numbers: H00016067; R01HL137734-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes