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

Study Overview
=================
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.

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.

Official Title
-----------------
AMADEUS Atrial Fibrillation Monitoring in the Ablacure Database Including Patient-reported Outcomes and an Educational Program Used for Structured Care.

Conditions
-----------------
Atrial Fibrillation, Quality of Life, Signs and Symptoms, Health Economy

Intervention / Treatment
-----------------
* Other: Internet-based education


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective, randomized and open study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Care as usual<br>Regular care at participating hospitals: Extended written information and education of patients with atrial fibrillation. | |
| Active Comparator: Internet-based education<br>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<br>* A six-step Internet-based patient education.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom burden | Arrhythmia related symptoms evaluated with the validated questionnaire ASTA (The Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmia) | One year after randomisation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial fibrillation, Symptom burden, Health-related quality of life, Health economy