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

NCT05951088 · tracked via the Priya Life Science Belgium tracker

Sponsor

University Hospital, Antwerp

Phase

Observational

Started

2023-05-23

Last updated

2026-05-08

Condition(s) studied

Follow-upEducationMobile Health

Investigational drug(s) / intervention(s)

Cardio2U follow-up

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

Study 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).

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Usability of the application — Change of usabilitiy of the application from baseline to12 months
Usability will be evaluated during the follow-up period using a specific 'Usability Questionnaire'.
Patient satisfaction with the application-driven follow-up — Change from baseline patient satisfaction with the application to 3- and 12 months
Patient satisfaction will be evaluated during the follow-up period using a specific 'Satisfaction Questionnaire'.
Long-term adherence — From date of randomization until end of study, assessed up to 36 months
Long-term adherence will be measured using the app user data

Trial sites (1)

Facility	City	Region	Status
University Hospital Antwerp	Edegem	Antwerp	Recruiting

More University Hospital, Antwerp trials in Belgium

Neuro-Pain Provides a Dynamic and Interactive Register for the Invasvive Neuromodulatory Therapies for Different Chronic Pain Syndromes. Patients Living in Belgium and Suffering From Persistent Spinal Pain Syndromes Type 2 as Well as Suffering From Complex Regional Pain Syndromes Are Included. Recruiting

Compairing R-ICNB and C-ICNB for Postoperative Pain Management After Minimal-invasive Anatomical Lung Resection Active, not recruiting

Methylated Biomarkers of Smoking as a Selection Tool in Participants for Lung Cancer Screening Recruiting

Multicenter Ventral Mesh Rectopexy Registry Collaborative Recruiting

Diagnosing Drug Allergy: the T is the Key Recruiting

Other trials for the same condition

#AWARE.HIV Europe: Supporting Healthcare Professionals to Find Undiagnosed HIV in European Hospitals: An Effectiveness-implementation Trial. Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05951088 on ClinicalTrials.gov ↗ ← All trials in Belgium