Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke

University of Massachusetts, Worcester

Status: Completed

Conditions: Atrial Fibrillation; Stroke

Treatments: Device: Cardea Solo by Cardiac Insight; Device: Kardia Mobile by AliveCor; Device: Testing Devices

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03761394

R01HL137734-01A1 (U.S. NIH Grant/Contract)

H00016067

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 50 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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120 participants in 4 patient groups

Intervention Group

Experimental group

Description:

Testing devices plus Cardea Solo device by Cardiac Insight for 14-day period.

Treatment:

Device: Testing Devices

Device: Cardea Solo by Cardiac Insight

Control Group

Active Comparator group

Description:

Only Cardea Solo device by Cardiac Insight for 14-day period.

Treatment:

Device: Cardea Solo by Cardiac Insight

Intervention Group for Extended Use

Experimental group

Description:

30-additional days of extended use of testing devices for adherence plus Kardia Mobile ECG device by AliveCor.

Treatment:

Device: Kardia Mobile by AliveCor

Device: Testing Devices

Control Group for Extended Use

No Intervention group

Description:

No device usage for 30-days following completion of the original 14-day period.