Clinical trial NCT05951088: Long-term Evaluation of a Mobile Application for Follow-up of Cardiac Patients (Cardio2U Study)
Official title: Long-term Evaluation of a Mobile Application for Follow-up of Cardiac Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Follow-up
Education
Mobile Health
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2023-07-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with AF and/or HF hospitalised at the cardiology department or coming for an outpatient visit, will be asked to participate in this study.

Brief 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.

Eligibility criteria: 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 outcomes:
measure: Usability of the application
timeFrame: Change of usabilitiy of the application from baseline to12 months
measure: Patient satisfaction with the application-driven follow-up
timeFrame: Change from baseline patient satisfaction with the application to 3- and 12 months
measure: Long-term adherence
timeFrame: From date of randomization until end of study, assessed up to 36 months
Secondary outcomes:
measure: Disease specific Knowledge
timeFrame: Change from baseline to 1, 3, 6, and 12 months
measure: Disease specific self-care management
timeFrame: Change from baseline to 3 and 12 months
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: University Hospital Antwerp
state: Antwerp
Study officials:
affiliation: University Hospital, Antwerp
name: Hein Heidbuchel
role: PRINCIPAL_INVESTIGATOR
References: