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Evaluation of the Added Value of an Internet-based Educational Program for Patients With Atrial Fibrillation. (AMADEUS)

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ClinicalTrials.gov Identifier: NCT03763500
Recruitment Status : Recruiting
First Posted : December 4, 2018
Last Update Posted : December 6, 2018
Sponsor:
Collaborators:
Dept of Internal Medicin, County Hospital Ryhov, Jönköping, Sweden.
Dept of Cardiology, Örebro University Hospital, Sweden
Information provided by (Responsible Party):
Ulla Walfridsson, Linkoeping University

Brief Summary:
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".

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Quality of Life Signs and Symptoms Health Economy Other: Internet-based education Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: prospective, randomized and open study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: AMADEUS Atrial Fibrillation Monitoring in the Ablacure Database Including Patient-reported Outcomes and an Educational Program Used for Structured Care.
Actual Study Start Date : December 3, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Care as usual

Regular care at participating hospitals:

Extended written information and education of patients with atrial fibrillation.

Active Comparator: Internet-based education
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.
Other: Internet-based education
A six-step Internet-based patient education.




Primary Outcome Measures :
  1. Symptom burden [ Time Frame: One year after randomisation ]
    Arrhythmia related symptoms evaluated with the validated questionnaire ASTA (The Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmia)


Secondary Outcome Measures :
  1. Health-related quality of life [ Time Frame: One year after randomisation ]
    Arrhythmia related impact on health-related quality of life evaluated with the validated questionnaire ASTA (The Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmia)

  2. Health economy [ Time Frame: One year prior to and one year after randomisation ]
    Health-care costs during the year prior to the study and for the two arm during the study period



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients evaluated for electrical or pharmaceutical cardioversion or evaluated for treatment with antiarrhythmic drugs for paroxysmal or persistent atrial fibrillation.

Exclusion Criteria:

Age below 18, planned for cardiac surgery or catheter ablation, acute coronary syndrome during three months prior to randomisation. Insufficient knowledge of the Swedish language or other reasons making it impossible for the patient to independently fill out the questionnaires.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03763500


Contacts
Contact: Ulla Walfridsson, RN PhD +46 101033711 ulla.walfridsson@regionostergotland.se
Contact: Hakan Walfridsson, MD PhD +46 101032199 hakan.walfridsson@regionostergotland.se

Locations
Sweden
Dept of Cardiology, University Hospital Not yet recruiting
Örebro, Närke, Sweden
Contact: Dritan Poci, MD PhD    +46 19602 10 00    dritan.poci@regionorebrolan.se   
Dept of Cardiology, HMC, University Hospital Recruiting
Linkoping, Ostergotland, Sweden, 58185
Contact: Ulla Walfridsson, RN PhD    +46 101033711    ulla.walfridsson@regionostergotland.se   
Contact: Hakan Walfridsson, MD PhD    +46 101032199    hakan.walfridsson@regionostergotland.se   
Dept of Internal Medicine, County Hospital Not yet recruiting
Jönköping, Småland, Sweden
Contact: Marija Jakovlevski Hedback, MD    +46 10241 00 00    marija.jakovlevski.hedback@rjl.se   
Sponsors and Collaborators
Ulla Walfridsson
Dept of Internal Medicin, County Hospital Ryhov, Jönköping, Sweden.
Dept of Cardiology, Örebro University Hospital, Sweden
Investigators
Study Chair: Ulla Walfridsson, RN PhD Dept of Cardiology, IMH, Linkoeping University, Sweden

Responsible Party: Ulla Walfridsson, Principal investigator, Linkoeping University
ClinicalTrials.gov Identifier: NCT03763500     History of Changes
Other Study ID Numbers: LiU Amadeus 2018
First Posted: December 4, 2018    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ulla Walfridsson, Linkoeping University:
Atrial fibrillation
Symptom burden
Health-related quality of life
Health economy

Additional relevant MeSH terms:
Atrial Fibrillation
Signs and Symptoms
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes