Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke
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ClinicalTrials.gov Identifier: NCT03761394 |
Recruitment Status :
Completed
First Posted : December 3, 2018
Last Update Posted : October 12, 2021
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Condition or disease | Intervention/treatment | Phase |
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Stroke Atrial Fibrillation | Device: Testing Devices Device: Cardea Solo by Cardiac Insight Device: Kardia Mobile by AliveCor | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Sequential Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Diagnostic |
Official Title: | Smartwatch Monitoring for Atrial Fibrillation After Stroke |
Actual Study Start Date : | September 3, 2019 |
Actual Primary Completion Date : | September 20, 2021 |
Actual Study Completion Date : | September 20, 2021 |

Arm | Intervention/treatment |
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Experimental: Intervention Group
Testing devices plus Cardea Solo device by Cardiac Insight for 14-day period.
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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.
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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.
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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.
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- Usability of Pulsewatch System: System usability scale & Rating Scale [ Time Frame: Assessed 14 days post the first randomization ]System usability scale, self- reported, of likes, dislikes and problems encountered with the smartphone application and smartwatch. Each items 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 overall rating of the application.
- Detection of Atrial Fibrillation [ Time Frame: Assessed throughout 14 day trial period ]Episodes of atrial fibrillation will be identified by the smartwatch bio-sensors and compared to the gold-standard monitor (Cardea Solo by Cardiac Insight).
- Change in Anxiety Symptoms [ Time Frame: Assessed at baseline, 14 days post the first randomization, 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.
- Change in General Health [ Time Frame: Assessed at baseline, 14 days post the first randomization, and at the last study visit 30 days post the second randomization ]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.
- Change in Patient Activation Score [ Time Frame: Assessed at baseline, 14 days post the first randomization, and at the last study visit 30 days post the second randomization ]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. The higher the score, the higher the activation the patient has for self-management of their condition.
- Change in Disease Management Self-Efficacy: The General Disease Management scale [ Time Frame: Assessed 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). The Symptom Management scale is a 5-item scale assessing confidence in managing chronic disease symptoms (items tailored to sample).
- Change in Medication Adherence [ Time Frame: Assessed 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.ARMS scores range from 1-4 (higher scores=poorer adherence).

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Ages Eligible for Study: | 50 Years to 100 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03761394
United States, Massachusetts | |
UMass Chan Medical School | |
Worcester, Massachusetts, United States, 01655 |
Principal Investigator: | Timothy Fitzgibbons, MD, PhD | UMass Medical School |
Documents provided by Timothy P Fitzgibbons, MD, PhD, University of Massachusetts, Worcester:
Responsible Party: | Timothy P Fitzgibbons, MD, PhD, Assistant Professor, University of Massachusetts, Worcester |
ClinicalTrials.gov Identifier: | NCT03761394 |
Other Study ID Numbers: |
H00016067 R01HL137734-01A1 ( U.S. NIH Grant/Contract ) |
First Posted: | December 3, 2018 Key Record Dates |
Last Update Posted: | October 12, 2021 |
Last Verified: | October 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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 |
Cardiac Arrhythmias |
Stroke Atrial Fibrillation Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Vascular Diseases Cardiovascular Diseases Arrhythmias, Cardiac Heart Diseases Pathologic Processes |