Education Clinical Trial
— Cardio2UOfficial title:
Long-term Evaluation of a Mobile Application for Follow-up of Cardiac Patients
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).
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. |
Country | Name | City | State |
---|---|---|---|
Belgium | University Hospital Antwerp | Edegem | Antwerp |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Antwerp |
Belgium,
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 |
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