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

NCT03763500 | Unknown DMC

• 1 other identifier: LiU Amadeus 2018
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

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".

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Symptom burden

  Arrhythmia related symptoms evaluated with the validated questionnaire ASTA (The Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmia)

  One year after randomisation

Secondary Outcomes (2)

• Health-related quality of life

  One year after randomisation

• Health economy

  One year prior to and one year after randomisation

Study Arms (2)

Care as usual

NO INTERVENTION

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

Internet-based education

ACTIVE COMPARATOR

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

Interventions

Internet-based education OTHER

A six-step Internet-based patient education.

Internet-based education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients evaluated for electrical or pharmaceutical cardioversion or evaluated for treatment with antiarrhythmic drugs for paroxysmal or persistent atrial fibrillation.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (3)

Dept of Cardiology, University Hospital

Örebro, Närke, Sweden

NOT YET RECRUITING

Dept of Internal Medicine, County Hospital

Jönköping, Småland, Sweden

NOT YET RECRUITING

Dept of Cardiology, HMC, University Hospital

Linköping, Östergötland County, 58185, Sweden

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Signs and Symptoms

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ulla Walfridsson, RN PhD

  Dept of Cardiology, IMH, Linkoeping University, Sweden

  STUDY CHAIR

Central Study Contacts

Ulla Walfridsson, RN PhD

CONTACT

+46 101033711; ulla.walfridsson@regionostergotland.se

Hakan Walfridsson, MD PhD

CONTACT

+46 101032199; hakan.walfridsson@regionostergotland.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Model Details: prospective, randomized and open study

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 4, 2018
• Study Start: December 3, 2018
• Primary Completion: June 30, 2021
• Study Completion: December 30, 2022
• Last Updated: September 2, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (3)