<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/NCT04468321</url>
  </required_header>
  <id_info>
    <org_study_id>2000028126</org_study_id>
    <secondary_id>6292-2020-R2TC-T12T13</secondary_id>
    <nct_id>NCT04468321</nct_id>
  </id_info>
  <brief_title>Heart Watch Study: a Pragmatic Randomized Controlled Trial</brief_title>
  <official_title>Heart Watch Study: a Pragmatic Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Evaluation System for health Technology Coordinating Center (NESTcc)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Yale University</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This will be a prospective multi-center, randomized, controlled trial of 150 patients&#xD;
      conducted to assess the impact of individual use of the Apple Watch compared to the Withings&#xD;
      Move on patient-reported and clinical outcomes at 6 months and up to 1 year.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a a randomized, controlled trial to determine the impact of the Apple Watch Series 6&#xD;
      compared to the Withings Move on both patient-reported outcomes and clinical utilization over&#xD;
      6 months and up to 1 year. Our research method will employ a patient-centered health data&#xD;
      sharing platform (called Hugo) for real-world surveillance of outcomes in 150 total patients&#xD;
      after they receive elective direct current cardioversion (DCCV) or catheter ablation for&#xD;
      treatment of atrial fibrillation or atrial flutter. Patients will be enrolled at each of 3&#xD;
      clinical sites: Yale-New Haven Hospital, the Mayo Clinic, and Duke Health. Half of the&#xD;
      patients will be randomized to receive the Apple Watch Series 6, while half will receive a&#xD;
      control device (Withings Move). Patients will then be queried about specific symptoms related&#xD;
      to atrial fibrillation and medication adherence monthly. This project will provide novel and&#xD;
      needed post-market data about the Apple Watch Series 6 ECG and irregular rhythm detection&#xD;
      notification features and, on a larger scale, help delineate the impact of an innovative&#xD;
      digital health technology on real-world patient outcomes.&#xD;
&#xD;
      Specific Aim 1: To assess the impact of using the Apple Watch ECG and irregular rhythm&#xD;
      notification features on patient-reported outcomes and clinical utilization after patients&#xD;
      receive cardioversion or catheter ablation for atrial fibrillation or atrial flutter.&#xD;
&#xD;
      Specific Aim 2: To determine the accuracy of the Apple Watch ECG compared to physician&#xD;
      interpretation of 12-lead ECGs obtained in routine clinical care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 18, 2021</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life)</measure>
    <time_frame>6 months</time_frame>
    <description>Difference in the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaire global score at 6 months compared to baseline between the Apple Watch and patients randomized to the Withings Move arm at 6 months compared to baseline. Reported on a scale from 0 to 100 with a higher score indicating a better outcome</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants with acute care use at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Acute care use will be compared between the two groups at 6 months. Acute care is defined as an emergency department visits, observation stays, and all hospitalizations over the 6 month period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants with acute care use at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>Acute care use will be compared between the two groups at 12 months. Acute care is defined as an emergency department visits, observation stays, and all hospitalizations over the 12 month period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants with outpatient care use at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Outpatient care use will be compared between the two groups at 6 months. Outpatient care is defined as outpatient primary care visits, outpatient cardiology or cardiac electrophysiology visits, and scheduled telephone encounters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants with outpatient care use at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>Outpatient care use will be compared between the two groups at 12 months. Outpatient care is defined as outpatient primary care visits, outpatient cardiology or cardiac electrophysiology visits, and scheduled telephone encounters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants with rhythm-related diagnostic testing at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Rhythm-related diagnostic testing will be assessed at 6 month including total ECGs and total outpatient heart rhythm monitors</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants with rhythm-related diagnostic testing at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>Rhythm-related diagnostic testing will be assessed at 12 month including total ECGs and total outpatient heart rhythm monitors</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients taking anticoagulants</measure>
    <time_frame>6 months</time_frame>
    <description>Anticoagulation use will be assessed at 6 months using the Brief Medication Questionnaire to trend patients' monthly responses about anticoagulation use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients taking anticoagulants</measure>
    <time_frame>12 months</time_frame>
    <description>Anticoagulation use will be assessed at 12 months using the Brief Medication Questionnaire to trend patients' monthly responses about anticoagulation use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domains</measure>
    <time_frame>6 months</time_frame>
    <description>Difference within individual domains of the Atrial Fibrillation Effect on QualiTy-of-life questionnaire between patients randomized to the Apple Watch and patients randomized to the Withings Move arm over the 6 month period. Reported on a scale from 0 to 100 with a higher score indicating a better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domains</measure>
    <time_frame>12 months</time_frame>
    <description>Difference within individual domains of the Atrial Fibrillation Effect on QualiTy-of-life questionnaire between patients randomized to the Apple Watch and patients randomized to the Withings Move arm over the 12 month period. Reported on a scale from 0 to 100 with a higher score indicating a better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants with clinical treatment for atrial fibrillation or flutter</measure>
    <time_frame>6 months</time_frame>
    <description>A composite outcome of rhythm control intervention, which is defined as at least one additional cardioversion, initiation of antiarrhythmic medical therapy, dose escalation of antiarrhythmic medication, change to another antiarrhythmic medication, or ablation for atrial fibrillation over the 6 month period. The medication data will be obtained primarily from electronic health record data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants with clinical treatment for atrial fibrillation or flutter</measure>
    <time_frame>12 months</time_frame>
    <description>A composite outcome of rhythm control intervention, which is defined as at least one additional cardioversion, initiation of antiarrhythmic medical therapy, dose escalation of antiarrhythmic medication, change to another antiarrhythmic medication, or ablation for atrial fibrillation over the 12 month period. The medication data will be obtained primarily from electronic health record data.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">105</enrollment>
  <condition>Cardioversion</condition>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Apple Watch</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be provided with the Apple Watch Series 6 with Irregular Rhythm Detection and ECG capabilities.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Withings Move</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients will be provided with the Withings Move with activity tracking.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Apple Watch</intervention_name>
    <description>Participants will be assigned to the Apple Watch arm to assess the impact of individual use of the Apple Watch on patient-reported and clinical utilization outcomes using Hugo.</description>
    <arm_group_label>Apple Watch</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Withings Move</intervention_name>
    <description>Participants will be assigned to the Withings Move arm to assess the impact of individual use of the Withings Move on patient-reported and clinical utilization outcomes using Hugo.</description>
    <arm_group_label>Withings Move</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;22&#xD;
&#xD;
          -  English-speaking&#xD;
&#xD;
          -  Planned for direct current cardioversion or catheter ablation for atrial fibrillation&#xD;
             or atrial flutter, as noted by referring clinical staff or on chart review&#xD;
&#xD;
          -  Participant is willing and able to read and sign consent and participate in study&#xD;
&#xD;
          -  Participant lives independently and does not require continuous care&#xD;
&#xD;
          -  Participant has an email account (or is willing to create one)&#xD;
&#xD;
          -  Participant has a compatible smartphone (iPhone 6s or later)&#xD;
&#xD;
          -  Participant is willing to wear only the device they are randomized to receive for the&#xD;
             study period for as many hours during the day as they are able, except for time spent&#xD;
             charging the device or in environments that may be suboptimal for the device&#xD;
&#xD;
          -  Participant is willing to use the Hugo mobile health platform and Apple Watch Series 6&#xD;
             or Withings Move&#xD;
&#xD;
          -  Participant has cardiology care at YNHH, Duke Health, or Mayo Clinic&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No exclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joseph Ross, MD, MHS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Peter Noseworthy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sreekanth Vemulapalli, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sanket Dhruva, MD, MHS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yale-New Haven Hospital</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://medrxiv.org/cgi/content/short/2021.07.10.21260230v1</url>
    <description>Preprint of protocol manuscript</description>
  </link>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>June 2, 2023</last_update_submitted>
  <last_update_submitted_qc>June 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Once the study has been completed, IPD will be shared in a way which will protect patient confidentiality using a data sharing platform for research purposes</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Data will become available once the study has been completed.</ipd_time_frame>
  </patient_data>
  <!-- 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/NCT04468321
org study id: 2000028126
secondary id: 6292-2020-R2TC-T12T13
nct id: NCT04468321
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
This will be a prospective multi-center, randomized, controlled trial of 150 patients
      conducted to assess the impact of individual use of the Apple Watch compared to the Withings
      Move on patient-reported and clinical outcomes at 6 months and up to 1 year.
This is a a randomized, controlled trial to determine the impact of the Apple Watch Series 6
      compared to the Withings Move on both patient-reported outcomes and clinical utilization over
      6 months and up to 1 year. Our research method will employ a patient-centered health data
      sharing platform (called Hugo) for real-world surveillance of outcomes in 150 total patients
      after they receive elective direct current cardioversion (DCCV) or catheter ablation for
      treatment of atrial fibrillation or atrial flutter. Patients will be enrolled at each of 3
      clinical sites: Yale-New Haven Hospital, the Mayo Clinic, and Duke Health. Half of the
      patients will be randomized to receive the Apple Watch Series 6, while half will receive a
      control device (Withings Move). Patients will then be queried about specific symptoms related
      to atrial fibrillation and medication adherence monthly. This project will provide novel and
      needed post-market data about the Apple Watch Series 6 ECG and irregular rhythm detection
      notification features and, on a larger scale, help delineate the impact of an innovative
      digital health technology on real-world patient outcomes.

      Specific Aim 1: To assess the impact of using the Apple Watch ECG and irregular rhythm
      notification features on patient-reported outcomes and clinical utilization after patients
      receive cardioversion or catheter ablation for atrial fibrillation or atrial flutter.

      Specific Aim 2: To determine the accuracy of the Apple Watch ECG compared to physician
      interpretation of 12-lead ECGs obtained in routine clinical care.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life)
time frame: 6 months
description: Difference in the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaire global score at 6 months compared to baseline between the Apple Watch and patients randomized to the Withings Move arm at 6 months compared to baseline. Reported on a scale from 0 to 100 with a higher score indicating a better outcome
measure: Proportion of participants with acute care use at 6 months
time frame: 6 months
description: Acute care use will be compared between the two groups at 6 months. Acute care is defined as an emergency department visits, observation stays, and all hospitalizations over the 6 month period.
measure: Proportion of participants with acute care use at 12 months
time frame: 12 months
description: Acute care use will be compared between the two groups at 12 months. Acute care is defined as an emergency department visits, observation stays, and all hospitalizations over the 12 month period.
measure: Proportion of participants with outpatient care use at 6 months
time frame: 6 months
description: Outpatient care use will be compared between the two groups at 6 months. Outpatient care is defined as outpatient primary care visits, outpatient cardiology or cardiac electrophysiology visits, and scheduled telephone encounters.
measure: Proportion of participants with outpatient care use at 12 months
time frame: 12 months
description: Outpatient care use will be compared between the two groups at 12 months. Outpatient care is defined as outpatient primary care visits, outpatient cardiology or cardiac electrophysiology visits, and scheduled telephone encounters.
measure: Proportion of participants with rhythm-related diagnostic testing at 6 months
time frame: 6 months
description: Rhythm-related diagnostic testing will be assessed at 6 month including total ECGs and total outpatient heart rhythm monitors
measure: Proportion of participants with rhythm-related diagnostic testing at 12 months
time frame: 12 months
description: Rhythm-related diagnostic testing will be assessed at 12 month including total ECGs and total outpatient heart rhythm monitors
measure: Proportion of patients taking anticoagulants
time frame: 6 months
description: Anticoagulation use will be assessed at 6 months using the Brief Medication Questionnaire to trend patients' monthly responses about anticoagulation use
measure: Proportion of patients taking anticoagulants
time frame: 12 months
description: Anticoagulation use will be assessed at 12 months using the Brief Medication Questionnaire to trend patients' monthly responses about anticoagulation use
measure: Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domains
time frame: 6 months
description: Difference within individual domains of the Atrial Fibrillation Effect on QualiTy-of-life questionnaire between patients randomized to the Apple Watch and patients randomized to the Withings Move arm over the 6 month period. Reported on a scale from 0 to 100 with a higher score indicating a better outcome
measure: Quality-of-life (Atrial Fibrillation Effect on QualiTy-of-life) Domains
time frame: 12 months
description: Difference within individual domains of the Atrial Fibrillation Effect on QualiTy-of-life questionnaire between patients randomized to the Apple Watch and patients randomized to the Withings Move arm over the 12 month period. Reported on a scale from 0 to 100 with a higher score indicating a better outcome
measure: Proportion of participants with clinical treatment for atrial fibrillation or flutter
time frame: 6 months
description: A composite outcome of rhythm control intervention, which is defined as at least one additional cardioversion, initiation of antiarrhythmic medical therapy, dose escalation of antiarrhythmic medication, change to another antiarrhythmic medication, or ablation for atrial fibrillation over the 6 month period. The medication data will be obtained primarily from electronic health record data.
measure: Proportion of participants with clinical treatment for atrial fibrillation or flutter
time frame: 12 months
description: A composite outcome of rhythm control intervention, which is defined as at least one additional cardioversion, initiation of antiarrhythmic medical therapy, dose escalation of antiarrhythmic medication, change to another antiarrhythmic medication, or ablation for atrial fibrillation over the 12 month period. The medication data will be obtained primarily from electronic health record data.
arm group label: Apple Watch
arm group type: Experimental
description: Patients will be provided with the Apple Watch Series 6 with Irregular Rhythm Detection and ECG capabilities.
arm group label: Withings Move
arm group type: Placebo Comparator
description: Patients will be provided with the Withings Move with activity tracking.
intervention type: Device
intervention name: Apple Watch
description: Participants will be assigned to the Apple Watch arm to assess the impact of individual use of the Apple Watch on patient-reported and clinical utilization outcomes using Hugo.
arm group label: Apple Watch
intervention type: Device
intervention name: Withings Move
description: Participants will be assigned to the Withings Move arm to assess the impact of individual use of the Withings Move on patient-reported and clinical utilization outcomes using Hugo.
arm group label: Withings Move
criteria: 
gender: All
minimum age: 22 Years
maximum age: N/A
healthy volunteers: No
last name: Joseph Ross, MD, MHS
role: Principal Investigator
affiliation: Yale University
last name: Peter Noseworthy, MD
role: Principal Investigator
affiliation: Mayo Clinic
last name: Sreekanth Vemulapalli, MD
role: Principal Investigator
affiliation: Duke University
last name: Sanket Dhruva, MD, MHS
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
facility: 
facility: 
country: United States
url: https://medrxiv.org/cgi/content/short/2021.07.10.21260230v1
description: Preprint of protocol manuscript
responsible party type: Sponsor
mesh term: Atrial Fibrillation
sharing ipd: Yes
ipd description: Once the study has been completed, IPD will be shared in a way which will protect patient confidentiality using a data sharing platform for research purposes
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Data will become available once the study has been completed.