Health TrialsbyHealthPanel

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

ConditionsFollow-upEducationMobile Health
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Antwerp

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Not able to speak and read Dutch,

Cognitive impaired (e.g. severe dementia),

No smartphone or tablet available.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Cardio2U follow-up

    Procedure/Surgery

    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

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: atrial fibrillation patients1 intervention
Group B: heart failure patients1 intervention

Trial outcomes

Primary outcomes

1

Usability of the application

Usability will be evaluated during the follow-up period using a specific 'Usability Questionnaire'.

Time frame
Change of usabilitiy of the application from baseline to12 months
2

Patient satisfaction with the application-driven follow-up

Patient satisfaction will be evaluated during the follow-up period using a specific 'Satisfaction Questionnaire'.

Time frame
Change from baseline patient satisfaction with the application to 3- and 12 months
3

Long-term adherence

Long-term adherence will be measured using the app user data

Time frame
From date of randomization until end of study, assessed up to 36 months

Secondary outcomes

1

Disease specific Knowledge

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 1, 3, 6, and 12 months
2

Disease specific self-care management

Patients self-care possibilities will be assessed during their follow-up using a specific self-care questionnaire

Time frame
Change from baseline to 3 and 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Antwerp

Lead sponsor

Source ClinicalTrials.gov
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