NCT05951088

Long-term Evaluation of a Mobile Application for Follow-up of Cardiac Patients (Cardio2U Study)

Long-term Evaluation of a Mobile Application for Follow-up of Cardiac Patients

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: University Hospital, Antwerp · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Follow-up
• Education
• Mobile Health

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-05-23
• Primary completion: 2026-05-30
• Completion: 2026-05-30
• First posted: 2023-07-18
• Last updated: 2025-09-10

Locations

1 site across 1 country: Belgium