Follow-upCardio2UNCT05951088
Long-term Evaluation of a Mobile Application for Follow-up of Cardiac Patients (Cardio2U Study)
An observational study of Follow-up and Education, run by University Hospital, Antwerp at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follow-up, Education, Mobile Health
- What is being tested?
- Cardio2U follow-up
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- 23 May 2023to 30 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Not able to speak and read Dutch,
- Cognitive impaired (e.g. severe dementia),
- No smartphone or tablet available.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
University Hospital Antwerp
Edegem, Antwerp, 2650
Lieselotte Knaepen, 00323821397, lieselotte.knaepen@uhasselt.be
About this study
Official 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).
Read the 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.
- Conditions
- Follow-up, Education, Mobile Health
- Being tested
- Cardio2U follow-up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardio2U follow-upProcedure or 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
| Study group | Role | What they receive |
|---|---|---|
| atrial fibrillation patients | AF patients hospitalised at the cardiology department or coming for an outpatient visit Receives: Procedure: Cardio2U follow-up | |
| heart failure patients | HF patients hospitalised at the cardiology department or coming for an outpatient visit Receives: Procedure: Cardio2U follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability of the application
Usability will be evaluated during the follow-up period using a specific 'Usability Questionnaire'.
Measured: 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'.
Measured: 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
Measured: From date of randomization until end of study, assessed up to 36 months
Secondary outcomes (2)
Disease specific Knowledge
Patients knowledge about AF and its treatment will be assessed during their follow-up using disease specific knowledge questionnaires
Measured: Change from baseline to 1, 3, 6, and 12 months
Disease specific self-care management
Patients self-care possibilities will be assessed during their follow-up using a specific self-care questionnaire
Measured: Change from baseline to 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start23 May 2023
- Primary completion30 May 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Follow-upStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hein Heidbuchel, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05951088
- Sponsor's protocol ID
- BUN B3002023000007
- Acronym
- Cardio2U
- Status last verified
- Apr 2026
- First submitted
- 15 Jun 2023
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Evaluation of a Mobile Application for Follow-up of Cardiac Patients
- ClinicalTrials.gov ID
- NCT05951088
- Acronym / sponsor ID
- Cardio2U / BUN B3002023000007
- Conditions
- Follow-up, Education, Mobile Health
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- 23 May 2023 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 18 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| atrial fibrillation patients | – | Procedure: Cardio2U follow-upAF patients hospitalised at the cardiology department or coming for an outpatient visit |
| heart failure patients | – | Procedure: Cardio2U follow-upHF patients hospitalised at the cardiology department or coming for an outpatient visit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Not able to speak and read Dutch,
- Cognitive impaired (e.g. severe dementia),
- No smartphone or tablet available.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardio2U follow-upDuring 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 | Procedure or surgery | atrial fibrillation patients, heart failure patients |
Primary outcome
Usability of the application
Time frame: Change of usabilitiy of the application from baseline to12 months
Usability will be evaluated during the follow-up period using a specific 'Usability Questionnaire'.
Patient satisfaction with the application-driven follow-up
Time frame: Change from baseline patient satisfaction with the application to 3- and 12 months
Patient satisfaction will be evaluated during the follow-up period using a specific 'Satisfaction Questionnaire'.
Long-term adherence
Time frame: From date of randomization until end of study, assessed up to 36 months
Long-term adherence will be measured using the app user data
2 secondary outcomes
Disease specific Knowledge
Time frame: Change from baseline to 1, 3, 6, and 12 months
Disease specific self-care management
Time frame: Change from baseline to 3 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hein Heidbuchel principal investigator
University Hospital, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Follow-up and Education, run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lieselotte Knaepen (003238213947, lieselotte.knaepen@uhasselt.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability of the application (time frame: Change of usabilitiy of the application from baseline to12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.