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Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03761394
Recruitment Status : Recruiting
First Posted : December 3, 2018
Last Update Posted : September 9, 2020
Sponsor:
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

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


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.



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).



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03761394


Contacts
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Contact: Timothy Fitzgibbons, MD, Phd 508-856-6858 timothy.fitzgibbons@umassmed.edu
Contact: Danielle DiMezza, BA 774-455-4711 danielle.dimezza@umassmed.edu

Locations
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United States, Massachusetts
UMass Memorial Medical Center Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Danielle DiMezza, BA    774-455-4711    danielle.dimezza@umassmed.edu   
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
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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:
Statistical Analysis Plan  [PDF] November 20, 2018
Study Protocol  [PDF] May 27, 2020

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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    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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