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NCT Number: NCT05951088

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

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).

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Antwerp

Edegem, Antwerp, 2650, Belgium

Location status: Recruiting

Location contact

Lieselotte Knaepen

CONTACT

[email protected]

00323821397

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years,
  • 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,
  • Patients who are capable of signing the informed consent.

Exclusion criteria

  • Not able to speak and read Dutch,
  • Cognitive impaired (e.g. severe dementia),
  • No smartphone or tablet available.

Treatment and study plan

Cardio2U follow-up

Procedure

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

Primary outcomes

  1. Usability of the application

    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'.

  2. Patient satisfaction with the application-driven follow-up

    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'.

  3. Long-term adherence

    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

Secondary outcomes

  1. Disease specific Knowledge

    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

  2. Disease specific self-care management

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Lieselotte Knaepen

CONTACT

[email protected]

003238213947

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Registry information

Official study title

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

Acronym: Cardio2U

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 18, 2023
Registry last updated
May 8, 2026

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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