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

Ulla Walfridsson

Status: Unknown

Conditions: Signs and Symptoms; Atrial Fibrillation; Health Economy; Quality of Life

Treatments: Other: Internet-based education

Study type: Interventional

Funder types: Other

Identifiers

NCT03763500

LiU Amadeus 2018

Details and patient eligibility

About

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".

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Care as usual

No Intervention group

Description:

Regular care at participating hospitals: Extended written information and education of patients with atrial fibrillation.

Internet-based education

Active Comparator group

Description:

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.

Treatment:

Other: Internet-based education