<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/NCT04490525</url>
  </required_header>
  <id_info>
    <org_study_id>N-20200037</org_study_id>
    <nct_id>NCT04490525</nct_id>
  </id_info>
  <brief_title>Future Patient - Telerehabilitation of Patients With Heart Failure II</brief_title>
  <official_title>Future Patient - Telerehabilitering af Patienter Med Hjertesvigt II</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 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 aim of the study is to test and evaluate the use of video consultations and an algorithm&#xD;
      for weight gain and loss in the Future Patient Telerehabilitation program for HF patients in&#xD;
      an RCT.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Next steps The Future Patient study - telerehabilitation of HF patients II&#xD;
&#xD;
      Based on the preliminary results from FP I (being published fall 2020) and a review of&#xD;
      literature, the investigators would like to improve our telerehabilitation program and&#xD;
      technologies in order to prepare for implementation of the FTP and technologies.&#xD;
&#xD;
        -  The HF patients in FP I expressed that the KCCQ was too long when having to complete the&#xD;
           questionnaire every other week. Therefore, the investigators would like to test a&#xD;
           shorter questionnaire HeartQoL (ESC) as a patient-reported outcome tool every month.&#xD;
&#xD;
        -  Video consultations instead of physical meetings with doctors and nurses at the&#xD;
           hospital. Currently, there is a lack of evidence regarding the use of video to decrease&#xD;
           physical visits at the hospitals instead of video consultations.&#xD;
&#xD;
        -  Test of algorithms for detecting an increase in weight on two days following clinical&#xD;
           cardiac guidelines (Ponikowski et al 2016).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Anticipated">September 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2024</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Health-related quality of life</measure>
    <time_frame>Intervention: at baseline, after 1 month, after 2 months, after 3 months, after 4 months, after 5 months, after 6 months. Control: baseline, after 3 months, after 6 months</time_frame>
    <description>15 % increase in health-related quality of life measured by HeartQoL</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reduction of the number of visits to the outpatient clinic</measure>
    <time_frame>For both intervention and control group: 6 months</time_frame>
    <description>Number of visits to the outpatient clinic between intervention and control group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of readmissions</measure>
    <time_frame>For both intervention and control group: 6 months</time_frame>
    <description>Number of readmissions between intervention and control group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of tele-communicational (phone and video) contacts</measure>
    <time_frame>For both intervention and control group: 6 months</time_frame>
    <description>Number of phone and video contacts to the healthcare professionals between intervention and control group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Experiences of HF patients and healthcare professionals with the use of video consultations</measure>
    <time_frame>Intervention group: at month 6</time_frame>
    <description>Interviews with HF patients and healthcare professionals regrind their experiences with the use of video consultations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Testing an algorithm on weight based on adherence</measure>
    <time_frame>Intervention group: at baseline, week: 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26</time_frame>
    <description>Questionnaires about feedback from an algorithm on weight</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Degree of depression</measure>
    <time_frame>For both intervention and control group: at baseline, 3 months, and 6 months</time_frame>
    <description>Degree of depression measured through HADS questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of the website &quot;Hjerteportalen.dk&quot;</measure>
    <time_frame>Intervention group: 6 months</time_frame>
    <description>Use of the website &quot;Hjerteportalen.dk&quot; based on log files</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention group will participate in the telerehabilitation program (please see detailed description of telerehabilitation program and technologies). The two steps in the telerehabilitation program last up to six months depending on how fast the titration of medicine in step one will be conducted. The intervention group will spend 5-10 minutes every day on monitoring themselves. Every month, an online questionnaire has to be filled in which will take up to 5 minutes. At enrolment, after titration of medicine, and the end of rehabilitation, the patient will fill in an online questionnaire. This will take 5 minutes each time. Selected patients and relatives will be asked if they wish to participate in interviews after participation in the trial. Each interview will last less than one hour. Number of interviews will be decided when data saturation has been achieved.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group will follow a conventional rehabilitation program (Egstrup et al 2015). The control subjects will participate in medicine titration for 1- 3 months and conventional rehabilitation for 3 months. The participation in the control group will last up to six months. The exact period depends on how fast the titration of medicine is conducted. At enrolment, after titration of medicine, and end of rehabilitation, the patient will fill in a questionnaire. This will take 5 minutes each time.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Telerehabilitation</intervention_name>
    <description>Blood pressure (iHealth Neo/BP5s), weight (iHealth Lina), step counters(Fitbit Inspire &amp; Charge 3), sleep sensor (Emfit QS), and tablet (iPad Air 2).</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed with HF NYHA Class II-IV, who have a current hospitalization for&#xD;
             acute decompensated HF or a visit to the HF outpatient clinic within the past two&#xD;
             weeks&#xD;
&#xD;
          -  Patients with an EF of 40% or less&#xD;
&#xD;
          -  Adults (18 years or older); no upper age limit&#xD;
&#xD;
          -  Patients living in Viborg and Skive Municipality&#xD;
&#xD;
          -  Patients living at home and capable of caring for themselves&#xD;
&#xD;
          -  Have basic computer skills or a relative who have basic computer skills&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Drug addiction defined as the use of cannabis, opioids or other drugs&#xD;
&#xD;
          -  Present and previous neurologic, musculoskeletal or cognitive disability or active&#xD;
             psychiatric history (as noted in the medical record) other than depression or anxiety&#xD;
             related to cardiac or other chronic illness&#xD;
&#xD;
          -  Lack of ability to cooperate&#xD;
&#xD;
          -  Does not speak/read/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>
  <overall_contact>
    <last_name>Birthe Dinesen, PhD,</last_name>
    <phone>+45 2051 5944</phone>
    <email>bid@hst.aau.dk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Malene Hollingdal, MD, PhD</last_name>
    <phone>78 44 00 00</phone>
    <email>malene.hollingdal@midt.rm.dk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Cardiology, Viborg Regional Hospital</name>
      <address>
        <city>Viborg</city>
        <zip>8800</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Malene Hollingdahl, Consultant, MD, PhD</last_name>
      <phone>+45 78447053</phone>
      <email>malene.hollingdal@viborg.rm.dk</email>
    </contact>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <link>
    <url>https://www.labwelfaretech.com/en/</url>
    <description>Read about project</description>
  </link>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 19, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>July 18, 2023</last_update_submitted>
  <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2023</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>Heart Failure</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/NCT04490525
org study id: N-20200037
nct id: NCT04490525
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to test and evaluate the use of video consultations and an algorithm
      for weight gain and loss in the Future Patient Telerehabilitation program for HF patients in
      an RCT.
Next steps The Future Patient study - telerehabilitation of HF patients II

      Based on the preliminary results from FP I (being published fall 2020) and a review of
      literature, the investigators would like to improve our telerehabilitation program and
      technologies in order to prepare for implementation of the FTP and technologies.

        -  The HF patients in FP I expressed that the KCCQ was too long when having to complete the
           questionnaire every other week. Therefore, the investigators would like to test a
           shorter questionnaire HeartQoL (ESC) as a patient-reported outcome tool every month.

        -  Video consultations instead of physical meetings with doctors and nurses at the
           hospital. Currently, there is a lack of evidence regarding the use of video to decrease
           physical visits at the hospitals instead of video consultations.

        -  Test of algorithms for detecting an increase in weight on two days following clinical
           cardiac guidelines (Ponikowski et al 2016).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Health-related quality of life
time frame: Intervention: at baseline, after 1 month, after 2 months, after 3 months, after 4 months, after 5 months, after 6 months. Control: baseline, after 3 months, after 6 months
description: 15 % increase in health-related quality of life measured by HeartQoL
measure: Reduction of the number of visits to the outpatient clinic
time frame: For both intervention and control group: 6 months
description: Number of visits to the outpatient clinic between intervention and control group
measure: Number of readmissions
time frame: For both intervention and control group: 6 months
description: Number of readmissions between intervention and control group
measure: Number of tele-communicational (phone and video) contacts
time frame: For both intervention and control group: 6 months
description: Number of phone and video contacts to the healthcare professionals between intervention and control group
measure: Experiences of HF patients and healthcare professionals with the use of video consultations
time frame: Intervention group: at month 6
description: Interviews with HF patients and healthcare professionals regrind their experiences with the use of video consultations
measure: Testing an algorithm on weight based on adherence
time frame: Intervention group: at baseline, week: 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26
description: Questionnaires about feedback from an algorithm on weight
measure: Degree of depression
time frame: For both intervention and control group: at baseline, 3 months, and 6 months
description: Degree of depression measured through HADS questionnaire
measure: Use of the website "Hjerteportalen.dk"
time frame: Intervention group: 6 months
description: Use of the website "Hjerteportalen.dk" based on log files
arm group label: Intervention
arm group type: Experimental
description: The intervention group will participate in the telerehabilitation program (please see detailed description of telerehabilitation program and technologies). The two steps in the telerehabilitation program last up to six months depending on how fast the titration of medicine in step one will be conducted. The intervention group will spend 5-10 minutes every day on monitoring themselves. Every month, an online questionnaire has to be filled in which will take up to 5 minutes. At enrolment, after titration of medicine, and the end of rehabilitation, the patient will fill in an online questionnaire. This will take 5 minutes each time. Selected patients and relatives will be asked if they wish to participate in interviews after participation in the trial. Each interview will last less than one hour. Number of interviews will be decided when data saturation has been achieved.
arm group label: Control
arm group type: No Intervention
description: The control group will follow a conventional rehabilitation program (Egstrup et al 2015). The control subjects will participate in medicine titration for 1- 3 months and conventional rehabilitation for 3 months. The participation in the control group will last up to six months. The exact period depends on how fast the titration of medicine is conducted. At enrolment, after titration of medicine, and end of rehabilitation, the patient will fill in a questionnaire. This will take 5 minutes each time.
intervention type: Device
intervention name: Telerehabilitation
description: Blood pressure (iHealth Neo/BP5s), weight (iHealth Lina), step counters(Fitbit Inspire & Charge 3), sleep sensor (Emfit QS), and tablet (iPad Air 2).
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Birthe Dinesen, PhD,
phone: +45 2051 5944
email: bid@hst.aau.dk
last name: Malene Hollingdal, MD, PhD
phone: 78 44 00 00
email: malene.hollingdal@midt.rm.dk
facility: 
status: Recruiting
contact: 
country: Denmark
url: https://www.labwelfaretech.com/en/
description: Read about project
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: Heart Failure
sharing ipd: No