<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/NCT04471623</url>
  </required_header>
  <id_info>
    <org_study_id>57019</org_study_id>
    <nct_id>NCT04471623</nct_id>
  </id_info>
  <brief_title>Decentralized Trial in Atrial Fibrillation Patients</brief_title>
  <acronym>DeTAP</acronym>
  <official_title>Decentralized Trial in Atrial Fibrillation Patients (DeTAP): Validation of a Combined Digital Health Technology Approach to Fully Decentralize an Intervention to Administer, Promote, and Track Oral Anticoagulant Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to validate an approach to decentralize, or virtualize, the&#xD;
      clinical trial experience for enrolled subjects, through the coordinated use of multiple&#xD;
      digital health and telehealth technologies. The study aims to validate the feasibility,&#xD;
      acceptability and best practices of coordinating/integrating several individual digital&#xD;
      health technologies to achieve execution of high compliance, cost-efficient, and&#xD;
      scientifically sound clinical trials.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 10, 2020</start_date>
  <completion_date type="Actual">March 12, 2021</completion_date>
  <primary_completion_date type="Actual">March 12, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Engagement with study protocol</measure>
    <time_frame>6 months</time_frame>
    <description>Composite endpoint of:&#xD;
% daily OAC adherence&#xD;
% Completion of telehealth visits&#xD;
% Completion of lab test&#xD;
% Survey completion</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effectiveness of notifications</measure>
    <time_frame>6 months</time_frame>
    <description>Composite endpoint of:&#xD;
Time from App-based survey notification to completion&#xD;
Time from App-based lab reminder notification to lab collection&#xD;
Time from App-based home vital sign/EKG reminder notification to vital sign/EKG collection</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">102</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>DeTAP Study App and Home Devices</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Monitoring of OAC administration, OAC adherence, and clinical status through combined decentralized technologies</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Use of DeTAP App and Home Devices</intervention_name>
    <description>DeTAP App (data collection, televisit function, information and reminders), Bluetooth-connected 6-lead home (electrocardiogram) EKG device, Bluetooth-connected blood pressure (BP) cuff</description>
    <arm_group_label>DeTAP Study App and Home Devices</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of Atrial Fibrillation documented (health record diagnosis or EKG) within&#xD;
             the past year and taking an oral anticoagulant (OAC) medication for stroke prevention&#xD;
&#xD;
          -  Uses a smart phone daily and is willing to use apps and home devices for the study&#xD;
&#xD;
          -  Agreeable to use a Televisit method to conduct all study visits from trial team&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active angina, stable or unstable, requiring urgent cardiovascular functional risk&#xD;
             stratification (stress testing or catheterization) or intervention. Or has congestive&#xD;
             heart failure that is not compensated or in which the subject is not euvolemic, as&#xD;
             determined by the treating MD&#xD;
&#xD;
          -  Individual has a condition the Investigator believes would interfere with his or her&#xD;
             ability to provide informed consent, comply with the study protocol, which might&#xD;
             confound the interpretation of the study results or put the person at undue risk.&#xD;
&#xD;
          -  Does not speak English&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rajesh Dash, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>K Josan, A Touros, C Petlura, V Parameswaran, U Grewal, M Senior, T Viethen, H Mundl, C Seninger, J Luithle, K Mahaffey, M Turakhia, R Dash, Validation of a pandemic-proof, decentralized cardiovascular trial: scalable design produces rapid recruitment, high engagement and protocol adherence in DeTAP (Decentralized Trial in Afib Patients), European Heart Journal, Volume 42, Issue Supplement_1, October 2021, ehab724.3177, https://doi.org/10.1093/eurheartj/ehab724.3177</citation>
  </reference>
  <results_reference>
    <citation>Sarraju A, Seninger C, Parameswaran V, Petlura C, Bazouzi T, Josan K, Grewal U, Viethen T, Mundl H, Luithle J, Basobas L, Touros A, Senior MJT, De Lombaert K, Mahaffey KW, Turakhia MP, Dash R. Pandemic-proof recruitment and engagement in a fully decentralized trial in atrial fibrillation patients (DeTAP). NPJ Digit Med. 2022 Jun 28;5(1):80. doi: 10.1038/s41746-022-00622-9.</citation>
    <PMID>35764796</PMID>
  </results_reference>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>March 22, 2023</last_update_submitted>
  <last_update_submitted_qc>March 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Rajesh Dash, MD PHD</investigator_full_name>
    <investigator_title>Associate Professor of Cardiovascular Medicine</investigator_title>
  </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>No</sharing_ipd>
  </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/NCT04471623
org study id: 57019
nct id: NCT04471623
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to validate an approach to decentralize, or virtualize, the
      clinical trial experience for enrolled subjects, through the coordinated use of multiple
      digital health and telehealth technologies. The study aims to validate the feasibility,
      acceptability and best practices of coordinating/integrating several individual digital
      health technologies to achieve execution of high compliance, cost-efficient, and
      scientifically sound clinical trials.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Engagement with study protocol
time frame: 6 months
description: Composite endpoint of:
% daily OAC adherence
% Completion of telehealth visits
% Completion of lab test
% Survey completion
measure: Effectiveness of notifications
time frame: 6 months
description: Composite endpoint of:
Time from App-based survey notification to completion
Time from App-based lab reminder notification to lab collection
Time from App-based home vital sign/EKG reminder notification to vital sign/EKG collection
arm group label: DeTAP Study App and Home Devices
arm group type: Experimental
description: Monitoring of OAC administration, OAC adherence, and clinical status through combined decentralized technologies
intervention type: Behavioral
intervention name: Use of DeTAP App and Home Devices
description: DeTAP App (data collection, televisit function, information and reminders), Bluetooth-connected 6-lead home (electrocardiogram) EKG device, Bluetooth-connected blood pressure (BP) cuff
arm group label: DeTAP Study App and Home Devices
criteria: 
gender: All
minimum age: 55 Years
maximum age: N/A
healthy volunteers: No
last name: Rajesh Dash, MD PhD
role: Principal Investigator
affiliation: Stanford University
facility: 
country: United States
citation: K Josan, A Touros, C Petlura, V Parameswaran, U Grewal, M Senior, T Viethen, H Mundl, C Seninger, J Luithle, K Mahaffey, M Turakhia, R Dash, Validation of a pandemic-proof, decentralized cardiovascular trial: scalable design produces rapid recruitment, high engagement and protocol adherence in DeTAP (Decentralized Trial in Afib Patients), European Heart Journal, Volume 42, Issue Supplement_1, October 2021, ehab724.3177, https://doi.org/10.1093/eurheartj/ehab724.3177
citation: Sarraju A, Seninger C, Parameswaran V, Petlura C, Bazouzi T, Josan K, Grewal U, Viethen T, Mundl H, Luithle J, Basobas L, Touros A, Senior MJT, De Lombaert K, Mahaffey KW, Turakhia MP, Dash R. Pandemic-proof recruitment and engagement in a fully decentralized trial in atrial fibrillation patients (DeTAP). NPJ Digit Med. 2022 Jun 28;5(1):80. doi: 10.1038/s41746-022-00622-9.
PMID: 35764796
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Rajesh Dash, MD PHD
investigator title: Associate Professor of Cardiovascular Medicine
mesh term: Atrial Fibrillation
sharing ipd: No