Status:
COMPLETED
Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke
Lead Sponsor:
University of Massachusetts, Worcester
Collaborating Sponsors:
University of Connecticut
Northeastern University
Conditions:
Stroke
Atrial Fibrillation
Eligibility:
All Genders
50-100 years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 20 2021
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03761394
Start Date
September 3 2019
End Date
September 20 2021
Last Update
November 18 2023
Active Locations (1)
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1
UMass Chan Medical School
Worcester, Massachusetts, United States, 01655