Atrial Fibrillation Clinical Trial
— AMADEUSOfficial title:
AMADEUS Atrial Fibrillation Monitoring in the Ablacure Database Including Patient-reported Outcomes and an Educational Program Used for Structured Care.
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".
Status | Recruiting |
Enrollment | 200 |
Est. completion date | December 30, 2022 |
Est. primary completion date | June 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Sweden | Dept of Internal Medicine, County Hospital | Jönköping | Småland |
Sweden | Dept of Cardiology, HMC, University Hospital | Linkoping | Ostergotland |
Sweden | Dept of Cardiology, University Hospital | Örebro | Närke |
Lead Sponsor | Collaborator |
---|---|
Ulla Walfridsson | Dept of Cardiology, Örebro University Hospital, Sweden, Dept of Internal Medicin, County Hospital Ryhov, Jönköping, Sweden. |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Symptom burden | Arrhythmia related symptoms evaluated with the validated questionnaire ASTA (The Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmia) | One year after randomisation | |
Secondary | Health-related quality of life | Arrhythmia related impact on health-related quality of life evaluated with the validated questionnaire ASTA (The Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmia) | One year after randomisation | |
Secondary | Health economy | Health-care costs during the year prior to the study and for the two arm during the study period | One year prior to and one year after randomisation |
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