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

Sponsor

Ulla Walfridsson (Other)

Overall Status

Recruiting

CT.gov ID

NCT03763500

Collaborator

Dept of Internal Medicin, County Hospital Ryhov, Jönköping, Sweden. (Other), Dept of Cardiology, Örebro University Hospital, Sweden (Other)

200

Enrollment

Locations

Arms

48.9

Anticipated Duration (Months)

66.7

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

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".

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation Quality of Life Signs and Symptoms Health Economy	Other: Internet-based education	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

prospective, randomized and open studyprospective, randomized and open study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 3, 2018

Anticipated Primary Completion Date :

Jun 30, 2021

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Care as usual Regular care at participating hospitals: Extended written information and education of patients with atrial fibrillation.
Active Comparator: 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.	Other: Internet-based education A six-step Internet-based patient education.

Arm

Intervention/Treatment

No Intervention: Care as usual

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

Active Comparator: 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.

Other: Internet-based education

A six-step Internet-based patient education.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dept of Cardiology, University Hospital	Örebro	Närke	Sweden
2	Dept of Cardiology, HMC, University Hospital	Linkoping	Ostergotland	Sweden	58185
3	Dept of Internal Medicine, County Hospital	Jönköping	Småland	Sweden

Sponsors and Collaborators

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

Investigators

Study Chair: Ulla Walfridsson, RN PhD, Dept of Cardiology, IMH, Linkoeping University, Sweden

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ulla Walfridsson, Principal investigator, Linkoeping University

ClinicalTrials.gov Identifier:

NCT03763500

Other Study ID Numbers:

LiU Amadeus 2018

First Posted:

Dec 4, 2018

Last Update Posted:

Sep 2, 2020

Last Verified:

Sep 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ulla Walfridsson, Principal investigator, Linkoeping University

Atrial fibrillation

Symptom burden

Health-related quality of life

Health economy

Additional relevant MeSH terms:

Atrial Fibrillation

Study Results

No Results Posted as of Sep 2, 2020