Effect of Targeted Education for Atrial Fibrillation Patients (Application Substudy)

  • STATUS
    Recruiting
  • End date
    Jul 24, 2021
  • participants needed
    221
  • sponsor
    University Hospital, Antwerp
Updated on 24 January 2021

Summary

The aim of this study is to evaluate a new and innovative educational application based on targeted education on the adherence level for NOACs (non-vitamin K antagonist oral anticoagulants) in AF patients, compared with standard care, online targeted education and in-person targeted education.

Several other parameters (knowledge level, quality of life, symptom burden, self-care capabilities, evaluation of educational efforts) will be studied. If resources allow, cardiovascular outcomes, cost-effectiveness and cost-utility will also be investigated.

Description

This substudy is part of the AF-EduCare study (NCT03707873): an extra study arm will be added to the main trial in which eligible AF patients (= in possession of a smartphone and capable working with their smartphone) will test this new educational application. Not eligible patients randomized to this group, will receive standard care.

This extra study arm will additionally include an anticipated 221 patients (eligible plus not eligible patients).

[An anticipated total of 1259 AF patients will be included for the AF-EduCare study (1038 AF patients) plus the AF-EduApp substudy (221 AF patients).]

Details
Condition Atrial Fibrillation and Flutter
Treatment Education
Clinical Study IdentifierNCT03788044
SponsorUniversity Hospital, Antwerp
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Atrial Fibrillation and Flutter?
Do you have any of these conditions: Do you have Atrial Fibrillation and Flutter??
Age 18 years
Patients in whom AF or atrial flutter is diagnosed with an electrocardiogram (12-lead, holter,...)
Patients who are capable to sign the informed consent

Exclusion Criteria

Not able to speak and read Dutch
Cognitive impaired (e.g. severe dementia)
Life expectancy is estimated to be less than 1 year
Ongoing participation in another clinical trial
Pregnant women
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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