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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03763500
Other study ID # LiU Amadeus 2018
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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