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

Not Applicable

• Conditions: Atrial Fibrillation; Health Economy; Quality of Life; Signs and Symptoms
• Interventions: Other: Internet-based education

• Registration Number: NCT03763500
• Lead Sponsor: Ulla Walfridsson

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.

Study Timeline

• Study Start: 2018-12-03
• Study First Submitted: 2018-12-03
• Study First Submitted QC: 2018-12-03
• Study First Posted: 2018-12-04
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-01
• Last Update Posted: 2020-09-02
• Primary Completion: 2021-06-30
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Internet-based education	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.

Primary Outcome Measures

Name	Time	Method
Symptom burden	One year after randomisation	Arrhythmia related symptoms evaluated with the validated questionnaire ASTA (The Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmia)

Secondary Outcome Measures

Name	Time	Method
Health-related quality of life	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	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

Trial Locations

Locations (3)

Dept of Cardiology, HMC, University Hospital; 🇸🇪 Linkoping, Ostergotland, Sweden

Dept of Cardiology, University Hospital; 🇸🇪 Örebro, Närke, Sweden

Dept of Internal Medicine, County Hospital; 🇸🇪 Jönköping, Småland, Sweden