<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03761394</url>
  </required_header>
  <id_info>
    <org_study_id>H00016067</org_study_id>
    <secondary_id>R01HL137734-01A1</secondary_id>
    <nct_id>NCT03761394</nct_id>
  </id_info>
  <brief_title>Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke</brief_title>
  <official_title>Smartwatch Monitoring for Atrial Fibrillation After Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Massachusetts, Worcester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Connecticut</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Northeastern University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Massachusetts, Worcester</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this research study is to develop a smartphone application capable of monitoring&#xD;
      paroxysmal atrial fibrillation (pAF) in people who have survived a stroke or transient&#xD;
      ischemic attack (TIA) or people who are at risk for a stroke and are age 50 and older. The&#xD;
      study team plans to develop a highly effective and easy to use cardiovascular surveillance&#xD;
      system to monitor patients for pAF on a nearly continuous basis. People involved in the&#xD;
      development of this system include patients, their caregivers, health care providers, and&#xD;
      computer programmers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 3, 2019</start_date>
  <completion_date type="Actual">September 20, 2021</completion_date>
  <primary_completion_date type="Actual">September 20, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Usability of Pulsewatch System: System usability scale &amp; Rating Scale</measure>
    <time_frame>Assessed 14 days post the first randomization</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Detection of Atrial Fibrillation</measure>
    <time_frame>Assessed throughout 14 day trial period</time_frame>
    <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).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Anxiety Symptoms</measure>
    <time_frame>Assessed at baseline, 14 days post the first randomization, and at the last study visit 30 days post the second randomization</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in General Health</measure>
    <time_frame>Assessed at baseline, 14 days post the first randomization, and at the last study visit 30 days post the second randomization</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Patient Activation Score</measure>
    <time_frame>Assessed at baseline, 14 days post the first randomization, and at the last study visit 30 days post the second randomization</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Disease Management Self-Efficacy: The General Disease Management scale</measure>
    <time_frame>Assessed at baseline and 14 days post the first randomization</time_frame>
    <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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Medication Adherence</measure>
    <time_frame>Assessed at baseline and 14 days post the first randomization</time_frame>
    <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).</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Stroke</condition>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Testing devices plus Cardea Solo device by Cardiac Insight for 14-day period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Only Cardea Solo device by Cardiac Insight for 14-day period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention Group for Extended Use</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>30-additional days of extended use of testing devices for adherence plus Kardia Mobile ECG device by AliveCor.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group for Extended Use</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No device usage for 30-days following completion of the original 14-day period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Testing Devices</intervention_name>
    <description>Pulsewatch system testing application on smartphone with smartwatch.</description>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_label>Intervention Group for Extended Use</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cardea Solo by Cardiac Insight</intervention_name>
    <description>Gold-standard cardiac monitor for comparison of testing devices.</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Kardia Mobile by AliveCor</intervention_name>
    <description>Mobile ECG device for comparison of testing devices during the extended use period.</description>
    <arm_group_label>Intervention Group for Extended Use</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  History of Transient Ischemic Attack (TIA) or stroke or at risk for stroke based on a&#xD;
             CHA2DS2-VASc score equal to or greater to a score of 3, presenting at the UMass&#xD;
             Memorial Medical Center (UMMMC) inpatient service or ambulatory clinic (neurology&#xD;
             clinics and cardiovascular clinics included)&#xD;
&#xD;
          -  Age: greater to or equal to 50 years of age&#xD;
&#xD;
          -  Able to sign informed consent&#xD;
&#xD;
          -  Willing to participant in a focus groups and/or Hack-a-thon for Aim 1 participants&#xD;
             only&#xD;
&#xD;
          -  Willing and capable of using Pulsewatch (smartwatch and smartphone app) daily for up&#xD;
             to 44-days and returning to UMMMC for up to two study visits for Aims 2 and 3&#xD;
             participants only&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Major contraindication to anti-coagulation treatment&#xD;
&#xD;
          -  Plans to move our of the area over the 44-day follow up period&#xD;
&#xD;
          -  Serious physical illness (e.g., unable to interact with a smart device, or communicate&#xD;
             verbally or via written text) that would interfere with study participation&#xD;
&#xD;
          -  Known allergies or hypersensitivities to medical grade hydrocolloid adhesives or&#xD;
             hydrogel&#xD;
&#xD;
          -  Patient with life threatening arrhythmia's who require in-patient monitoring for&#xD;
             immediate analysis&#xD;
&#xD;
          -  Patient with implantable pacemaker as paced beats interfere with ECG readings&#xD;
&#xD;
          -  Lacking capacity to sign informed consent&#xD;
&#xD;
          -  Unable to read and write in English&#xD;
&#xD;
          -  Plans to move from the area during the study period&#xD;
&#xD;
          -  Unwilling to complete all study procedures&#xD;
&#xD;
          -  Major contraindication to anti-coagulation treatment (i.e., major hemorrhagic stroke)&#xD;
&#xD;
          -  Individuals who are not yet adults&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Prisoners&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Timothy Fitzgibbons, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UMass Medical School</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UMass Chan Medical School</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01655</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>October 8, 2021</last_update_submitted>
  <last_update_submitted_qc>October 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Massachusetts, Worcester</investigator_affiliation>
    <investigator_full_name>Timothy P Fitzgibbons, MD, PhD</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Cardiac Arrhythmias</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 27, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT03761394/Prot_008.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 20, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT03761394/SAP_003.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <pending_results>
    <submitted>May 2, 2023</submitted>
    <returned>May 31, 2023</returned>
    <submitted>June 6, 2023</submitted>
    <returned>June 29, 2023</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03761394
org study id: H00016067
secondary id: R01HL137734-01A1
nct id: NCT03761394
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
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.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Diagnostic
masking: Single (Investigator)
measure: Usability of Pulsewatch System: System usability scale & Rating Scale
time frame: Assessed 14 days post the first randomization
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.
measure: Detection of Atrial Fibrillation
time frame: Assessed throughout 14 day trial period
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).
measure: 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
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.
measure: 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
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.
measure: 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
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.
measure: Change in Disease Management Self-Efficacy: The General Disease Management scale
time frame: Assessed at baseline and 14 days post the first randomization
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).
measure: Change in Medication Adherence
time frame: Assessed at baseline and 14 days post the first randomization
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).
arm group label: Intervention Group
arm group type: Experimental
description: Testing devices plus Cardea Solo device by Cardiac Insight for 14-day period.
arm group label: Control Group
arm group type: Active Comparator
description: Only Cardea Solo device by Cardiac Insight for 14-day period.
arm group label: Intervention Group for Extended Use
arm group type: Experimental
description: 30-additional days of extended use of testing devices for adherence plus Kardia Mobile ECG device by AliveCor.
arm group label: Control Group for Extended Use
arm group type: No Intervention
description: No device usage for 30-days following completion of the original 14-day period.
intervention type: Device
intervention name: Testing Devices
description: Pulsewatch system testing application on smartphone with smartwatch.
arm group label: Intervention Group
arm group label: Intervention Group for Extended Use
intervention type: Device
intervention name: Cardea Solo by Cardiac Insight
description: Gold-standard cardiac monitor for comparison of testing devices.
arm group label: Control Group
arm group label: Intervention Group
intervention type: Device
intervention name: Kardia Mobile by AliveCor
description: Mobile ECG device for comparison of testing devices during the extended use period.
arm group label: Intervention Group for Extended Use
criteria: 
gender: All
minimum age: 50 Years
maximum age: 100 Years
healthy volunteers: No
last name: Timothy Fitzgibbons, MD, PhD
role: Principal Investigator
affiliation: UMass Medical School
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Massachusetts, Worcester
investigator full name: Timothy P Fitzgibbons, MD, PhD
investigator title: Assistant Professor
mesh term: Stroke
mesh term: Atrial Fibrillation
sharing ipd: No
provided document: 
provided document: 
submitted: May 2, 2023
returned: May 31, 2023
submitted: June 6, 2023
returned: June 29, 2023