Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke

• ClinicalTrials.gov Identifier: NCT03761394
• Recruitment Status: Completed
• First Posted: December 3, 2018
• Last Update Posted: October 12, 2021
• Sponsor: University of Massachusetts, Worcester
• Collaborators: University of Connecticut; Northeastern University; Brigham and Women's Hospital; National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): Timothy P Fitzgibbons, MD, PhD, University of Massachusetts, Worcester

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.

Condition or disease	Intervention/treatment	Phase
Stroke; Atrial Fibrillation	Device: Testing Devices; Device: Cardea Solo by Cardiac Insight; Device: Kardia Mobile by AliveCor	Not Applicable

Study Design

• 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

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention Group; Testing devices plus Cardea Solo device by Cardiac Insight for 14-day period.	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.	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.	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.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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).

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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).
5. 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).

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, Massachusetts

UMass Chan Medical School

Worcester, Massachusetts, United States, 01655

Sponsors and Collaborators

University of Massachusetts, Worcester

University of Connecticut

Northeastern University

Brigham and Women's Hospital

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Timothy Fitzgibbons, MD, PhD; UMass Medical School

  Study Documents (Full-Text)

Documents provided by Timothy P Fitzgibbons, MD, PhD, University of Massachusetts, Worcester:

Study Protocol  [PDF] May 27, 2020

Statistical Analysis Plan  [PDF] November 20, 2018

More Information

• 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
• 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

Keywords provided by Timothy P Fitzgibbons, MD, PhD, University of Massachusetts, Worcester:

Cardiac Arrhythmias

Additional relevant MeSH terms:

Stroke; Atrial Fibrillation; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes