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

NCT ID: NCT03763500

Last Updated: 2020-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-03

Study Completion Date

2022-12-30

Brief Summary

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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

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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.

Conditions

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Atrial Fibrillation Quality of Life Signs and Symptoms Health Economy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

prospective, randomized and open study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Care as usual

Regular care at participating hospitals:

Extended written information and education of patients with atrial fibrillation.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

Internet-based education

Intervention Type OTHER

A six-step Internet-based patient education.

Interventions

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Internet-based education

A six-step Internet-based patient education.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dept of Internal Medicin, County Hospital Ryhov, Jönköping, Sweden.

UNKNOWN

Sponsor Role collaborator

Dept of Cardiology, Örebro University Hospital, Sweden

UNKNOWN

Sponsor Role collaborator

Ulla Walfridsson

OTHER_GOV

Sponsor Role lead

Responsible Party

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Ulla Walfridsson

Principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ulla Walfridsson, RN PhD

Role: STUDY_CHAIR

Dept of Cardiology, IMH, Linkoeping University, Sweden

Locations

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Dept of Cardiology, University Hospital

Örebro, Närke, Sweden

Site Status NOT_YET_RECRUITING

Dept of Internal Medicine, County Hospital

Jönköping, Småland, Sweden

Site Status NOT_YET_RECRUITING

Dept of Cardiology, HMC, University Hospital

Linköping, Östergötland County, Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Ulla Walfridsson, RN PhD

Role: CONTACT

+46 101033711

Hakan Walfridsson, MD PhD

Role: CONTACT

+46 101032199

Facility Contacts

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Dritan Poci, MD PhD

Role: primary

+46 19602 10 00

Marija Jakovlevski Hedback, MD

Role: primary

+46 10241 00 00

Ulla Walfridsson, RN PhD

Role: primary

+46 101033711

Hakan Walfridsson, MD PhD

Role: backup

+46 101032199

Other Identifiers

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LiU Amadeus 2018

Identifier Type: -

Identifier Source: org_study_id

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