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

NCT ID: NCT05951088

Last Updated: 2025-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-23

Study Completion Date

2026-05-30

Brief Summary

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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

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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.

Conditions

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Follow-up Education Mobile Health

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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atrial fibrillation patients

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

Cardio2U follow-up

Intervention Type 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

heart failure patients

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

Cardio2U follow-up

Intervention Type 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

Interventions

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Cardio2U follow-up

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Antwerp

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hein Heidbuchel

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Antwerp

Locations

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University Hospital Antwerp

Edegem, Antwerp, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Lieselotte Knaepen

Role: CONTACT

003238213947

Facility Contacts

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Lieselotte Knaepen

Role: primary

00323821397

Other Identifiers

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BUN B3002023000007

Identifier Type: -

Identifier Source: org_study_id

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