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

NCT05951088 | Recruiting

• 1 other identifier: BUN B3002023000007
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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).

Conditions

Follow-up; Education; Mobile Health

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• Disease specific Knowledge

  Change from baseline to 1, 3, 6, and 12 months

• Disease specific self-care management

  Change from baseline to 3 and 12 months

Study Arms (2)

atrial fibrillation patients

AF patients hospitalised at the cardiology department or coming for an outpatient visit

Procedure: Cardio2U follow-up

heart failure patients

HF patients hospitalised at the cardiology department or coming for an outpatient visit

Procedure: Cardio2U follow-up

Interventions

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

atrial fibrillation patients; heart failure patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (1)

University Hospital Antwerp

Edegem, Antwerp, 2650, Belgium

RECRUITING

Study Officials

• Hein Heidbuchel

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lieselotte Knaepen

CONTACT

003238213947; lieselotte.knaepen@uhasselt.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: July 18, 2023
• Study Start: May 23, 2023
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-03

Locations

BE (1)