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
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation Quality of Life Signs and Symptoms Health Economy||Other: Internet-based education||Not Applicable|
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|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||prospective, randomized and open study|
|Masking:||None (Open Label)|
|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|
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.
- 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)
- 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)
- 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
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
|Contact: Ulla Walfridsson, RN PhD||+46 email@example.com|
|Contact: Hakan Walfridsson, MD PhD||+46 firstname.lastname@example.org|
|Dept of Cardiology, University Hospital||Not yet recruiting|
|Örebro, Närke, Sweden|
|Contact: Dritan Poci, MD PhD +46 19602 10 00 email@example.com|
|Dept of Cardiology, HMC, University Hospital||Recruiting|
|Linkoping, Ostergotland, Sweden, 58185|
|Contact: Ulla Walfridsson, RN PhD +46 101033711 firstname.lastname@example.org|
|Contact: Hakan Walfridsson, MD PhD +46 101032199 email@example.com|
|Dept of Internal Medicine, County Hospital||Not yet recruiting|
|Jönköping, Småland, Sweden|
|Contact: Marija Jakovlevski Hedback, MD +46 10241 00 00 firstname.lastname@example.org|
|Study Chair:||Ulla Walfridsson, RN PhD||Dept of Cardiology, IMH, Linkoeping University, Sweden|