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

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).

Study Overview

• Status: Recruiting
• Conditions: Education; Mobile Health; Follow-up
• Intervention / Treatment: Procedure: Cardio2U follow-up

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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Lieselotte Knaepen; Phone Number: 003238213947; Email: lieselotte.knaepen@uhasselt.be

Study Locations

• Belgium
  • Antwerp
    • Edegem, Antwerp, Belgium, 2650
      • Recruiting
      • University Hospital Antwerp
      • Contact: Lieselotte Knaepen; Phone Number: 00323821397; Email: lieselotte.knaepen@uhasselt.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
atrial fibrillation patients; AF patients hospitalised at the cardiology department or coming for an outpatient visit	Procedure: 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
heart failure patients; HF patients hospitalised at the cardiology department or coming for an outpatient visit	Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp
• Investigators: Principal Investigator: Hein Heidbuchel, University Hospital, Antwerp

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2023
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026

Study Registration Dates

• First Submitted: June 15, 2023
• First Submitted That Met QC Criteria: July 10, 2023
• First Posted (Actual): July 18, 2023

Study Record Updates

• Last Update Posted (Actual): July 18, 2023
• Last Update Submitted That Met QC Criteria: July 10, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: BUN B3002023000007

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No