<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/NCT04493437</url>
  </required_header>
  <id_info>
    <org_study_id>N-20190059</org_study_id>
    <nct_id>NCT04493437</nct_id>
  </id_info>
  <brief_title>Future Patient - Telerehabilitation of Atrial Fibrillation Patients</brief_title>
  <official_title>Future Patient - Telerehabilitation of Atrial Fibrillation Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aalborg University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Aage and Johanne Louis-Hansens Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Laboratory of Welfare Technology, Department of Health Science and Technology, AAU</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Viborg Regional Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Skive Healthcare Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Viborg Healthcare Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Department of Psychology, Aarhus University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Department of Architecture, Design and Media Technology, Aalborg University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Department of Photonics Engineering, Technical University of Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Aalborg University</source>
  <oversight_info>
    <has_dmc>Yes</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 idea behind this Future Patient pilot study is to explore and evaluate the feasibility of&#xD;
      individualized telerehabilitation technologies and programs for patients with atrial&#xD;
      fibrillation (AF).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: To explore the feasibility of individualized telerehabilitation technologies and a&#xD;
      program for patients with AF.&#xD;
&#xD;
      Outcome measures:&#xD;
&#xD;
      To evaluate two concepts for telerehabilitation programs and technologies for patients with&#xD;
      AF in order to see how these concepts can increase self-management for patients in their&#xD;
      rehabilitation process. The following outcome measures are in focus:&#xD;
&#xD;
      Primary outcomes:&#xD;
&#xD;
        -  Usability of technologies seen from patients' and healthcare professionals' perspectives&#xD;
&#xD;
        -  Test and evaluation of the contents of telerehabilitation programs&#xD;
&#xD;
      Secondary outcomes:&#xD;
&#xD;
        -  Measurements of clinical data&#xD;
&#xD;
        -  Patients' and relatives' expectations for and experience with participation in the&#xD;
           telerehabilitation program&#xD;
&#xD;
        -  Healthcare professionals' experience with workflows and collaboration between each other&#xD;
           in the telerehabilitation program&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2, 2019</start_date>
  <completion_date type="Actual">May 26, 2021</completion_date>
  <primary_completion_date type="Actual">February 28, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical test of the contents of telerehabilitation programs using interviews</measure>
    <time_frame>At day 30</time_frame>
    <description>Interviews with patients regarding the use of technology, themes on rehabilitation for AF patients on web portal, and education at healthcare center</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Usability test of technologies seen from patients' and healthcare professionals' perspectives</measure>
    <time_frame>At day 30</time_frame>
    <description>Interviews with patients regarding the user-friendliness of technologies and layout on web portal</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measurements of blood pressure</measure>
    <time_frame>Every Wednesday: week 1, 2, 3, 4, and 5.</time_frame>
    <description>Evaluation of changes in systolic and diastolic blood pressure measured ones a week</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurements of pulse</measure>
    <time_frame>Every Wednesday: week 1, 2, 3, 4, and 5.</time_frame>
    <description>Evaluation of changes in pulse in beats per minut measured ones a week</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurements of weight</measure>
    <time_frame>Every Wednesday: week 1, 2, 3, 4, and 5.</time_frame>
    <description>Evaluation of changes in weight in kg measured ones a week</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurements of electrocardiography (ECG) ECG QT Interval</measure>
    <time_frame>Every Wednesday: week 1, 2, 3, 4, and 5.</time_frame>
    <description>Evaluation of ECG QT Interval measured ones a week</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurements of number of steps and sleep</measure>
    <time_frame>Everyday: week 1, 2, 3, 4, and 5.</time_frame>
    <description>Evaluation of changes in number of steps and sleep measured every day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Interviews on patients' and relatives' expectations for and experience with participation in the telerehabilitation program</measure>
    <time_frame>At day 30</time_frame>
    <description>Interviews with patients and relatives regarding their experiences with participation in the tele rehabilitation program</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Telerehabilitation group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Device: Telerehabilitation Blood pressure (iHealth Neo), weight (iHealth Lina), step counters(Fitbit Inspire &amp; Charge 3), sleep sensor (Emfit QS), tablet (iPad Air 2), and ECG recorder (AliveCor KardiaMobile).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Telerehabilitation group B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Device: Telerehabilitation + rehabilitation at health care center Telerehabilitation: Blood pressure (iHealth Neo), weight (iHealth Lina), step counters(Fitbit Inspire &amp; Charge 3), sleep sensor (Emfit QS), tablet (iPad Air 2), and ECG recorder (AliveCor KardiaMobile).&#xD;
Rehabilitation at health care center: The rehabilitation will consist of four closed group sessions focusing on patient education. The groups will consist of both patients and relatives. The program at the health care center will not include any psychological tests or data control. Duration is 4 x 2 hours sessions over a period of 1 month.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Telerehabilitation</intervention_name>
    <description>Blood pressure (iHealth Neo), weight (iHealth Lina), step counters(Fitbit Inspire &amp; Charge 3), sleep sensor (Emfit QS), tablet (iPad Air 2), and ECG recorder (AliveCor KardiaMobile).</description>
    <arm_group_label>Telerehabilitation group A</arm_group_label>
    <arm_group_label>Telerehabilitation group B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed with AF&#xD;
&#xD;
          -  Adults ≥ 18 years; no upper age limit&#xD;
&#xD;
          -  Patients living in Skive and Viborg Municipality&#xD;
&#xD;
          -  Living at home and capable of caring for him/herself&#xD;
&#xD;
          -  Basic computer skills or a relative with basic computer skills&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Lack of ability to cooperate&#xD;
&#xD;
          -  Patient does not speak, read and understand Danish&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Cardiology, Viborg Regional Hospital</name>
      <address>
        <city>Viborg</city>
        <zip>8800</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>May 26, 2021</last_update_submitted>
  <last_update_submitted_qc>May 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aalborg University</investigator_affiliation>
    <investigator_full_name>Birthe Dinesen</investigator_full_name>
    <investigator_title>Professor, PhD, Master in Political Science, RN, Head of Laboratory of Welfare Technology - Telehealth &amp; Telerehabilitation</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/NCT04493437
org study id: N-20190059
nct id: NCT04493437
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The idea behind this Future Patient pilot study is to explore and evaluate the feasibility of
      individualized telerehabilitation technologies and programs for patients with atrial
      fibrillation (AF).
Objective: To explore the feasibility of individualized telerehabilitation technologies and a
      program for patients with AF.

      Outcome measures:

      To evaluate two concepts for telerehabilitation programs and technologies for patients with
      AF in order to see how these concepts can increase self-management for patients in their
      rehabilitation process. The following outcome measures are in focus:

      Primary outcomes:

        -  Usability of technologies seen from patients' and healthcare professionals' perspectives

        -  Test and evaluation of the contents of telerehabilitation programs

      Secondary outcomes:

        -  Measurements of clinical data

        -  Patients' and relatives' expectations for and experience with participation in the
           telerehabilitation program

        -  Healthcare professionals' experience with workflows and collaboration between each other
           in the telerehabilitation program
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Clinical test of the contents of telerehabilitation programs using interviews
time frame: At day 30
description: Interviews with patients regarding the use of technology, themes on rehabilitation for AF patients on web portal, and education at healthcare center
measure: Usability test of technologies seen from patients' and healthcare professionals' perspectives
time frame: At day 30
description: Interviews with patients regarding the user-friendliness of technologies and layout on web portal
measure: Measurements of blood pressure
time frame: Every Wednesday: week 1, 2, 3, 4, and 5.
description: Evaluation of changes in systolic and diastolic blood pressure measured ones a week
measure: Measurements of pulse
time frame: Every Wednesday: week 1, 2, 3, 4, and 5.
description: Evaluation of changes in pulse in beats per minut measured ones a week
measure: Measurements of weight
time frame: Every Wednesday: week 1, 2, 3, 4, and 5.
description: Evaluation of changes in weight in kg measured ones a week
measure: Measurements of electrocardiography (ECG) ECG QT Interval
time frame: Every Wednesday: week 1, 2, 3, 4, and 5.
description: Evaluation of ECG QT Interval measured ones a week
measure: Measurements of number of steps and sleep
time frame: Everyday: week 1, 2, 3, 4, and 5.
description: Evaluation of changes in number of steps and sleep measured every day
measure: Interviews on patients' and relatives' expectations for and experience with participation in the telerehabilitation program
time frame: At day 30
description: Interviews with patients and relatives regarding their experiences with participation in the tele rehabilitation program
arm group label: Telerehabilitation group A
arm group type: Experimental
description: Device: Telerehabilitation Blood pressure (iHealth Neo), weight (iHealth Lina), step counters(Fitbit Inspire & Charge 3), sleep sensor (Emfit QS), tablet (iPad Air 2), and ECG recorder (AliveCor KardiaMobile).
arm group label: Telerehabilitation group B
arm group type: Experimental
description: Device: Telerehabilitation + rehabilitation at health care center Telerehabilitation: Blood pressure (iHealth Neo), weight (iHealth Lina), step counters(Fitbit Inspire & Charge 3), sleep sensor (Emfit QS), tablet (iPad Air 2), and ECG recorder (AliveCor KardiaMobile).
Rehabilitation at health care center: The rehabilitation will consist of four closed group sessions focusing on patient education. The groups will consist of both patients and relatives. The program at the health care center will not include any psychological tests or data control. Duration is 4 x 2 hours sessions over a period of 1 month.
intervention type: Device
intervention name: Telerehabilitation
description: Blood pressure (iHealth Neo), weight (iHealth Lina), step counters(Fitbit Inspire & Charge 3), sleep sensor (Emfit QS), tablet (iPad Air 2), and ECG recorder (AliveCor KardiaMobile).
arm group label: Telerehabilitation group A
arm group label: Telerehabilitation group B
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Aalborg University
investigator full name: Birthe Dinesen
investigator title: Professor, PhD, Master in Political Science, RN, Head of Laboratory of Welfare Technology - Telehealth & Telerehabilitation
mesh term: Atrial Fibrillation
sharing ipd: No