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Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke

Primary Purpose

Stroke, Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Testing Devices
Cardea Solo by Cardiac Insight
Kardia Mobile by AliveCor
Sponsored by
University of Massachusetts, Worcester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Stroke focused on measuring Cardiac Arrhythmias

Eligibility Criteria

50 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • UMass Chan Medical School

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Intervention Group for Extended Use

Control Group for Extended Use

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Usability of Pulsewatch System: System usability scale & Rating Scale
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
Episodes of atrial fibrillation will be identified by the smartwatch bio-sensors and compared to the gold-standard monitor (Cardea Solo by Cardiac Insight).

Secondary Outcome Measures

Change in Anxiety Symptoms
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
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
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
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
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).

Full Information

First Posted
November 29, 2018
Last Updated
October 8, 2021
Sponsor
University of Massachusetts, Worcester
Collaborators
University of Connecticut, Northeastern University, Brigham and Women's Hospital, National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT03761394
Brief Title
Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke
Official Title
Smartwatch Monitoring for Atrial Fibrillation After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
September 3, 2019 (Actual)
Primary Completion Date
September 20, 2021 (Actual)
Study Completion Date
September 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Worcester
Collaborators
University of Connecticut, Northeastern University, Brigham and Women's Hospital, National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Atrial Fibrillation
Keywords
Cardiac Arrhythmias

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Testing devices plus Cardea Solo device by Cardiac Insight for 14-day period.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Only Cardea Solo device by Cardiac Insight for 14-day period.
Arm Title
Intervention Group for Extended Use
Arm Type
Experimental
Arm Description
30-additional days of extended use of testing devices for adherence plus Kardia Mobile ECG device by AliveCor.
Arm Title
Control Group for Extended Use
Arm Type
No Intervention
Arm Description
No device usage for 30-days following completion of the original 14-day period.
Intervention Type
Device
Intervention Name(s)
Testing Devices
Intervention Description
Pulsewatch system testing application on smartphone with smartwatch.
Intervention Type
Device
Intervention Name(s)
Cardea Solo by Cardiac Insight
Intervention Description
Gold-standard cardiac monitor for comparison of testing devices.
Intervention Type
Device
Intervention Name(s)
Kardia Mobile by AliveCor
Intervention Description
Mobile ECG device for comparison of testing devices during the extended use period.
Primary Outcome Measure Information:
Title
Usability of Pulsewatch System: System usability scale & Rating Scale
Description
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.
Time Frame
Assessed 14 days post the first randomization
Title
Detection of Atrial Fibrillation
Description
Episodes of atrial fibrillation will be identified by the smartwatch bio-sensors and compared to the gold-standard monitor (Cardea Solo by Cardiac Insight).
Time Frame
Assessed throughout 14 day trial period
Secondary Outcome Measure Information:
Title
Change in Anxiety Symptoms
Description
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.
Time Frame
Assessed at baseline, 14 days post the first randomization, and at the last study visit 30 days post the second randomization
Title
Change in General Health
Description
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.
Time Frame
Assessed at baseline, 14 days post the first randomization, and at the last study visit 30 days post the second randomization
Title
Change in Patient Activation Score
Description
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.
Time Frame
Assessed at baseline, 14 days post the first randomization, and at the last study visit 30 days post the second randomization
Title
Change in Disease Management Self-Efficacy: The General Disease Management scale
Description
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).
Time Frame
Assessed at baseline and 14 days post the first randomization
Title
Change in Medication Adherence
Description
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).
Time Frame
Assessed at baseline and 14 days post the first randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy Fitzgibbons, MD, PhD
Organizational Affiliation
UMass Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMass Chan Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke

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