Cardiovascular disease remains a leading cause of death worldwide including in Tunisia, with
about 49% of the deaths from coronary heart disease (CHD) [1, 2].
Faced with the increase in the number of chronic diseases with the aging of the population,
and with the observation of the insufficiency of therapeutic control, a new need has emerged,
that of having a patient as a partner in care.
Participatory medicine involves a collaborative approach between patients and healthcare
professionals, where patients are actively engaged in making decisions about their own treatment. This fosters better mutual understanding and enables more precise customization of
medical care.
Therapeutic patient education (TPE) is a humanistic approach centered on the patient, his
needs, and resources. It is proposed not only to help the patient understand the disease and
treatment but also to help them become autonomous.
In fact, TPE is an approach to facilitate patient and family learning about the treatment of
disease and the adoption of self-management behaviors and lifestyles to improve physical and
psychosocial health outcomes (eg, biomarkers, quality of life) [3]. The goal of TPE is to
improve health outcomes, including by preventing avoidable complications [4]. In prior studies, investigators have reported the positive impact of TPE on knowledge, behavioral, psychosocial, and health outcomes [5].
The appropriate application of the TPE program should result in a better quality of life for
people with coronary heart disease.
The therapeutic digital platform
The mobile application will be built using the Progressive Web App (PWA) approach. The
frontend will be developed using the React framework, while the backend will be powered by
Node.js. The application will also offer offline functionality, allowing users to interact with it
even without an internet connection. Regarding the patient-entered data, it will be secured
using the AES protocol (Advanced Encryption Standard).
- First step : Inclusion in the therapeutic digital platform
At the end of the TPE program, the medical team verifies eligibility for the digital platform
program. A “therapeutic support” contract is signed by the program participant and the medical team, setting out the therapeutic objectives during follow-up, as well as the parameters to
be collected and transmitted to the platform.
The TPE team will educate the patient in the use of the mobile application, which is based
on the codes and uses of consumer applications. - Second step : digital monitoring phase
Every day, the patient will be invited to transmit the monitoring parameters set out in the
“therapeutic support” contract.
Data will be transmitted asynchronously and securely on the monitoring platform. - Third step : Data analysis phase
The medical team can interact with the patient via the platform. If necessary, the patient
can be called into the center by the medical team for reassessment and early consultation, in
order to optimize his or her care pathway. - Forth step : Assessment phase
At 12 months, an assessment of knowledge retention will be carried out, as well as the incidence of major cardiovascular events.
Outcomes
Primary outcome : The primary outcome of this study is the occurrence of major cardiovascular events in the year following hospital discharge for the control group, and in the year
following completion of the TPE program with digital follow-up for the intervention group.
The primary outcome is based on the occurrence of acute myocardial infarction, stable
angina, coronary revascularization, stroke, hospitalized heart failure, or death attributable to
any cardiovascular disease [15]. Information on the primary outcome will be systematically
obtained through follow-up interview at 12 months and confirmed by reviewing patients’
medical records. If a patient dies during follow-up, this information will be obtained directly
from patient’s family or confirmed by physician.
Secondary outcomes : The secondary outcomes of the study include changes in health
behaviors (smoking cessation, adoption of a healthy diet, physical activity), medication adherence, cardiovascular health score and health-related quality of life which will be assessed using
the validated Tunisian version of the SF-12 health survey.