Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-03

Study Completion Date

2021-09-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Stroke Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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Intervention Group

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

Group Type EXPERIMENTAL

Testing Devices

Intervention Type DEVICE

Pulsewatch system testing application on smartphone with smartwatch.

Cardea Solo by Cardiac Insight

Intervention Type DEVICE

Gold-standard cardiac monitor for comparison of testing devices.

Control Group

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

Group Type ACTIVE_COMPARATOR

Cardea Solo by Cardiac Insight

Intervention Type DEVICE

Gold-standard cardiac monitor for comparison of testing devices.

Intervention Group for Extended Use

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

Group Type EXPERIMENTAL

Testing Devices

Intervention Type DEVICE

Pulsewatch system testing application on smartphone with smartwatch.

Kardia Mobile by AliveCor

Intervention Type DEVICE

Mobile ECG device for comparison of testing devices during the extended use period.

Control Group for Extended Use

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Testing Devices

Pulsewatch system testing application on smartphone with smartwatch.

Intervention Type DEVICE

Cardea Solo by Cardiac Insight

Gold-standard cardiac monitor for comparison of testing devices.

Intervention Type DEVICE

Kardia Mobile by AliveCor

Mobile ECG device for comparison of testing devices during the extended use period.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No