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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05951088
Other study ID # BUN B3002023000007
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 23, 2023
Est. completion date May 30, 2026

Study information

Verified date June 2023
Source University Hospital, Antwerp
Contact Lieselotte Knaepen
Phone 003238213947
Email lieselotte.knaepen@uhasselt.be
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This trial has to aim to evaluate an innovative, in-house developed mobile application supporting patients in their home environment by actively involving them in different aspects of their condition and treatment. The usability, long-term adherence and patient satisfaction will be studied in patients with atrial fibrillation (AF) and/or heart failure (HF).


Description:

Atrial fibrillation (AF) and heart failure (HF) are global cardiovascular disease epidemics associated with significant morbidity and mortality. Their prevalence is already high and will continue to increase in the coming decades. A structured and efficient care system encompassing various aspects is needed to manage AF and HF morbidity and mortality. Technological developments and the increased use of smart devices, including in medical care, create opportunities to implement mobile applications to provide continuous, high-quality follow-up to patients. Our in-house developed application, recently improved and expended, provides a reliable source of educational material on AF and HF, with the ability to save health appointments, enter measurements (such as heart rate, blood pressure, weight) and keep a medication list (including notifications when medication should be taken). In addition, the application includes questionnaires to assess, for example, patients' knowledge, selfcare, quality of life, physical activity and symptoms. The application allows personalisation per patient depending on the clinical setting and indication. The innovative application will be evaluated in terms of usability, long-term adherence and patient satisfaction.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date May 30, 2026
Est. primary completion date May 30, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Age = 18 years, 2. Patients in whom AF or atrial flutter is diagnosed with an electrocardiogram (12-lead, Holter monitor,…) and/or patients in whom HF is diagnosed in their medical records, 3. Patients who are capable of signing the informed consent. Exclusion Criteria: 1. Not able to speak and read Dutch, 2. Cognitive impaired (e.g. severe dementia), 3. No smartphone or tablet available.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Cardio2U follow-up
During the follow-up period, participants will have access to the application and will be able to explore the different modules. At fixed time points, the application will allow them to fill in questionnaires about the application's usability and patient satisfaction. App user data will track how long and how often patients visit the application and which aspects are mostly used. In addition, at different time points during the study, patients will be asked to complete clinical questionnaires regarding e.g. patients' knowledge and self-care abilities. The results of these questionnaires can be used in a more clinical way as they will be accessible to doctors and nurses in the healthcare provider dashboard and can support targeted patient follow-up and guidance

Locations

Country Name City State
Belgium University Hospital Antwerp Edegem Antwerp

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Usability of the application Usability will be evaluated during the follow-up period using a specific 'Usability Questionnaire'. Change of usabilitiy of the application from baseline to12 months
Primary Patient satisfaction with the application-driven follow-up Patient satisfaction will be evaluated during the follow-up period using a specific 'Satisfaction Questionnaire'. Change from baseline patient satisfaction with the application to 3- and 12 months
Primary Long-term adherence Long-term adherence will be measured using the app user data From date of randomization until end of study, assessed up to 36 months
Secondary Disease specific Knowledge Patients knowledge about AF and its treatment will be assessed during their follow-up using disease specific knowledge questionnaires Change from baseline to 1, 3, 6, and 12 months
Secondary Disease specific self-care management Patients self-care possibilities will be assessed during their follow-up using a specific self-care questionnaire Change from baseline to 3 and 12 months
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