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

Atrial Fibrillation Clinical Trial

— AMADEUS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03763500
• Other study ID #: LiU Amadeus 2018
• Status: Recruiting
• Phase: N/A
• Start date: December 3, 2018
• Est. completion date: December 30, 2022

Study information

• Verified date: September 2020
• Source: Linkoeping University
• Contact: Ulla Walfridsson, RN PhD
• Phone: +46 101033711
• Email: ulla.walfridsson[@]regionostergotland.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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".

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Health Economy
• Quality of Life
• Signs and Symptoms

Intervention

Other:
• Internet-based education
A six-step Internet-based patient education.

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Ulla Walfridsson	Dept of Cardiology, Örebro University Hospital, Sweden, Dept of Internal Medicin, County Hospital Ryhov, Jönköping, Sweden.

Country where clinical trial is conducted

Sweden, 

Outcome

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