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

Primary Purpose

Atrial Fibrillation, Quality of Life, Signs and Symptoms

Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Internet-based education
Sponsored by
Ulla Walfridsson
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Symptom burden, Health-related quality of life, Health economy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Dept of Cardiology, University Hospital
  • Dept of Cardiology, HMC, University HospitalRecruiting
  • Dept of Internal Medicine, County Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Care as usual

Internet-based education

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Symptom burden
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
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
Health-care costs during the year prior to the study and for the two arm during the study period

Full Information

First Posted
December 3, 2018
Last Updated
September 1, 2020
Sponsor
Ulla Walfridsson
Collaborators
Dept of Internal Medicin, County Hospital Ryhov, Jönköping, Sweden., Dept of Cardiology, Örebro University Hospital, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT03763500
Brief Title
Evaluation of the Added Value of an Internet-based Educational Program for Patients With Atrial Fibrillation.
Acronym
AMADEUS
Official Title
AMADEUS Atrial Fibrillation Monitoring in the Ablacure Database Including Patient-reported Outcomes and an Educational Program Used for Structured Care.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 3, 2018 (Actual)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ulla Walfridsson
Collaborators
Dept of Internal Medicin, County Hospital Ryhov, Jönköping, Sweden., Dept of Cardiology, Örebro University Hospital, Sweden

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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".
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Quality of Life, Signs and Symptoms, Health Economy
Keywords
Atrial fibrillation, Symptom burden, Health-related quality of life, Health economy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective, randomized and open study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Care as usual
Arm Type
No Intervention
Arm Description
Regular care at participating hospitals: Extended written information and education of patients with atrial fibrillation.
Arm Title
Internet-based education
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Internet-based education
Intervention Description
A six-step Internet-based patient education.
Primary Outcome Measure Information:
Title
Symptom burden
Description
Arrhythmia related symptoms evaluated with the validated questionnaire ASTA (The Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmia)
Time Frame
One year after randomisation
Secondary Outcome Measure Information:
Title
Health-related quality of life
Description
Arrhythmia related impact on health-related quality of life evaluated with the validated questionnaire ASTA (The Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmia)
Time Frame
One year after randomisation
Title
Health economy
Description
Health-care costs during the year prior to the study and for the two arm during the study period
Time Frame
One year prior to and one year after randomisation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ulla Walfridsson, RN PhD
Phone
+46 101033711
Email
ulla.walfridsson@regionostergotland.se
First Name & Middle Initial & Last Name or Official Title & Degree
Hakan Walfridsson, MD PhD
Phone
+46 101032199
Email
hakan.walfridsson@regionostergotland.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulla Walfridsson, RN PhD
Organizational Affiliation
Dept of Cardiology, IMH, Linkoeping University, Sweden
Official's Role
Study Chair
Facility Information:
Facility Name
Dept of Cardiology, University Hospital
City
Örebro
State/Province
Närke
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dritan Poci, MD PhD
Phone
+46 19602 10 00
Email
dritan.poci@regionorebrolan.se
Facility Name
Dept of Cardiology, HMC, University Hospital
City
Linkoping
State/Province
Ostergotland
ZIP/Postal Code
58185
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ulla Walfridsson, RN PhD
Phone
+46 101033711
Email
ulla.walfridsson@regionostergotland.se
First Name & Middle Initial & Last Name & Degree
Hakan Walfridsson, MD PhD
Phone
+46 101032199
Email
hakan.walfridsson@regionostergotland.se
Facility Name
Dept of Internal Medicine, County Hospital
City
Jönköping
State/Province
Småland
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marija Jakovlevski Hedback, MD
Phone
+46 10241 00 00
Email
marija.jakovlevski.hedback@rjl.se

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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