University Hospital Antwerp
Edegem, Antwerp, 2650, Belgium
Location status: Recruiting
NCT Number: NCT05951088
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).
Interested in participating?
Request Info18 year and older
All sexes
Observational
Edegem, Antwerp, 2650, Belgium
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: Change of usabilitiy of the application from baseline to12 months
Usability will be evaluated during the follow-up period using a specific 'Usability Questionnaire'.
Time frame: 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'.
Time frame: From date of randomization until end of study, assessed up to 36 months
Long-term adherence will be measured using the app user data
Time frame: Change from baseline to 1, 3, 6, and 12 months
Patients knowledge about AF and its treatment will be assessed during their follow-up using disease specific knowledge questionnaires
Time frame: Change from baseline to 3 and 12 months
Patients self-care possibilities will be assessed during their follow-up using a specific self-care questionnaire
Contact information is provided by the study sponsor or research team.
University Hospital, Antwerp
Other
Long-term Evaluation of a Mobile Application for Follow-up of Cardiac Patients
Acronym: Cardio2U
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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