<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/NCT03763500</url>
  </required_header>
  <id_info>
    <org_study_id>LiU Amadeus 2018</org_study_id>
    <nct_id>NCT03763500</nct_id>
  </id_info>
  <brief_title>Evaluation of the Added Value of an Internet-based Educational Program for Patients With Atrial Fibrillation.</brief_title>
  <acronym>AMADEUS</acronym>
  <official_title>AMADEUS Atrial Fibrillation Monitoring in the Ablacure Database Including Patient-reported Outcomes and an Educational Program Used for Structured Care.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ulla Walfridsson</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dept of Internal Medicin, County Hospital Ryhov, Jönköping, Sweden.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dept of Cardiology, Örebro University Hospital, Sweden</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Linkoeping 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>
      This study is prospective, open and randomized concerning the value of an Internet-based&#xD;
      educational program for patients with atrial fibrillation compared to &quot;care as usual&quot;.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the present guidelines for treatment of atrial fibrillation education and information are&#xD;
      underlined as important parts of the care. The investigators developed an Internet-based&#xD;
      educational program in close collaboration with patients, specialists in the field, both&#xD;
      physicians and nurses, and a phycologist, specialized in cognitive behavioral therapy.&#xD;
&#xD;
      The aim of the study is to evaluate this program in comparison to &quot;care as usual&quot; with&#xD;
      reduction in symptom burden as primary endpoint, secondary endpoints being improvement in&#xD;
      health-related quality of life and reduction in health-care costs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 3, 2018</start_date>
  <completion_date type="Anticipated">December 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 30, 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>Parallel Assignment</intervention_model>
    <intervention_model_description>prospective, randomized and open study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Symptom burden</measure>
    <time_frame>One year after randomisation</time_frame>
    <description>Arrhythmia related symptoms evaluated with the validated questionnaire ASTA (The Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmia)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life</measure>
    <time_frame>One year after randomisation</time_frame>
    <description>Arrhythmia related impact on health-related quality of life evaluated with the validated questionnaire ASTA (The Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmia)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health economy</measure>
    <time_frame>One year prior to and one year after randomisation</time_frame>
    <description>Health-care costs during the year prior to the study and for the two arm during the study period</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Atrial Fibrillation</condition>
  <condition>Quality of Life</condition>
  <condition>Signs and Symptoms</condition>
  <condition>Health Economy</condition>
  <arm_group>
    <arm_group_label>Care as usual</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Regular care at participating hospitals:&#xD;
Extended written information and education of patients with atrial fibrillation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Internet-based education</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients randomized in this arm receive an Internet-based educational program in addition to extended written information. This includes 6 steps with detailed information on background, symptoms, investigations, treatment options, life-style as well as one part with guides to self management.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Internet-based education</intervention_name>
    <description>A six-step Internet-based patient education.</description>
    <arm_group_label>Internet-based education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients evaluated for electrical or pharmaceutical cardioversion or evaluated for&#xD;
        treatment with antiarrhythmic drugs for paroxysmal or persistent atrial fibrillation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Age below 18, planned for cardiac surgery or catheter ablation, acute coronary syndrome&#xD;
        during three months prior to randomisation. Insufficient knowledge of the Swedish language&#xD;
        or other reasons making it impossible for the patient to independently fill out the&#xD;
        questionnaires.&#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_official>
    <last_name>Ulla Walfridsson, RN PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Dept of Cardiology, IMH, Linkoeping University, Sweden</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ulla Walfridsson, RN PhD</last_name>
    <phone>+46 101033711</phone>
    <email>ulla.walfridsson@regionostergotland.se</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hakan Walfridsson, MD PhD</last_name>
    <phone>+46 101032199</phone>
    <email>hakan.walfridsson@regionostergotland.se</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Dept of Cardiology, University Hospital</name>
      <address>
        <city>Örebro</city>
        <state>Närke</state>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Dritan Poci, MD PhD</last_name>
      <phone>+46 19602 10 00</phone>
      <email>dritan.poci@regionorebrolan.se</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dept of Cardiology, HMC, University Hospital</name>
      <address>
        <city>Linkoping</city>
        <state>Ostergotland</state>
        <zip>58185</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ulla Walfridsson, RN PhD</last_name>
      <phone>+46 101033711</phone>
      <email>ulla.walfridsson@regionostergotland.se</email>
    </contact>
    <contact_backup>
      <last_name>Hakan Walfridsson, MD PhD</last_name>
      <phone>+46 101032199</phone>
      <email>hakan.walfridsson@regionostergotland.se</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Dept of Internal Medicine, County Hospital</name>
      <address>
        <city>Jönköping</city>
        <state>Småland</state>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Marija Jakovlevski Hedback, MD</last_name>
      <phone>+46 10241 00 00</phone>
      <email>marija.jakovlevski.hedback@rjl.se</email>
    </contact>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>September 1, 2020</last_update_submitted>
  <last_update_submitted_qc>September 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Linkoeping University</investigator_affiliation>
    <investigator_full_name>Ulla Walfridsson</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Atrial fibrillation</keyword>
  <keyword>Symptom burden</keyword>
  <keyword>Health-related quality of life</keyword>
  <keyword>Health economy</keyword>
  <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/NCT03763500
org study id: LiU Amadeus 2018
nct id: NCT03763500
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is prospective, open and randomized concerning the value of an Internet-based
      educational program for patients with atrial fibrillation compared to "care as usual".
In the present guidelines for treatment of atrial fibrillation education and information are
      underlined as important parts of the care. The investigators developed an Internet-based
      educational program in close collaboration with patients, specialists in the field, both
      physicians and nurses, and a phycologist, specialized in cognitive behavioral therapy.

      The aim of the study is to evaluate this program in comparison to "care as usual" with
      reduction in symptom burden as primary endpoint, secondary endpoints being improvement in
      health-related quality of life and reduction in health-care costs.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: prospective, randomized and open study
primary purpose: Treatment
masking: None (Open Label)
measure: Symptom burden
time frame: One year after randomisation
description: Arrhythmia related symptoms evaluated with the validated questionnaire ASTA (The Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmia)
measure: Health-related quality of life
time frame: One year after randomisation
description: Arrhythmia related impact on health-related quality of life evaluated with the validated questionnaire ASTA (The Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmia)
measure: Health economy
time frame: One year prior to and one year after randomisation
description: Health-care costs during the year prior to the study and for the two arm during the study period
arm group label: Care as usual
arm group type: No Intervention
description: Regular care at participating hospitals:
Extended written information and education of patients with atrial fibrillation.
arm group label: Internet-based education
arm group type: Active Comparator
description: Patients randomized in this arm receive an Internet-based educational program in addition to extended written information. This includes 6 steps with detailed information on background, symptoms, investigations, treatment options, life-style as well as one part with guides to self management.
intervention type: Other
intervention name: Internet-based education
description: A six-step Internet-based patient education.
arm group label: Internet-based education
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ulla Walfridsson, RN PhD
role: Study Chair
affiliation: Dept of Cardiology, IMH, Linkoeping University, Sweden
last name: Ulla Walfridsson, RN PhD
phone: +46 101033711
email: ulla.walfridsson@regionostergotland.se
last name: Hakan Walfridsson, MD PhD
phone: +46 101032199
email: hakan.walfridsson@regionostergotland.se
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Not yet recruiting
contact: 
country: Sweden
responsible party type: Sponsor-Investigator
investigator affiliation: Linkoeping University
investigator full name: Ulla Walfridsson
investigator title: Principal investigator
mesh term: Atrial Fibrillation
sharing ipd: No