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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03763500
Acronym
AMADEUS
Enrollment
200
Registered
2018-12-04
Start date
2018-12-03
Completion date
2022-12-30
Last updated
2020-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Atrial fibrillation, Symptom burden, Health-related quality of life, Health economy

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.

Interventions

OTHERInternet-based education

A six-step Internet-based patient education.

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

prospective, randomized and open study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Symptom burdenOne year after randomisationArrhythmia related symptoms evaluated with the validated questionnaire ASTA (The Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmia)

Secondary

MeasureTime frameDescription
Health-related quality of lifeOne year after randomisationArrhythmia related impact on health-related quality of life evaluated with the validated questionnaire ASTA (The Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmia)
Health economyOne year prior to and one year after randomisationHealth-care costs during the year prior to the study and for the two arm during the study period

Countries

Sweden

Contacts

Primary ContactUlla Walfridsson, RN PhD
ulla.walfridsson@regionostergotland.se+46 101033711
Backup ContactHakan Walfridsson, MD PhD
hakan.walfridsson@regionostergotland.se+46 101032199

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026