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

Education Clinical Trial

— Cardio2U  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05951088
• Other study ID #: BUN B3002023000007
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Education
• Follow-up
• Mobile Health

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