Therapeutic education of patients with coronary heart disease: Impact of digital platform monitoring in preventing major cardiovascular events in Tunisia: Study protocol

Abstract

Background: 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.

Methods: This study is a randomized controlled trial. Patients with coronary heart disease will be recruited from one clinical site and randomly assigned into two groups: the intervention group and the control group. All participants will be followed up for a total of one year (with three-time points for data collection). Patients who are assigned to the intervention group will receive therapeutic education at first. The digital platform will then allow healthcare providers to accompany them outside the hospital walls. The primary outcome is the incidence of major cardiovascular events within one year of discharge. Main secondary outcomes include changes in health behaviors, medication adherence, and quality of life score. The digital platform is a multi-professional telemonitoring platform that allows care teams to accompany the patient outside the hospital walls. It allows the collection and transmits information from the patient's home to the therapeutic education team. All data will be secured at a certified host. The patient application provides data on compliance, adherence to physical activity (number of steps taken per day), adequate diet (weight gain, food consumed during the meal, compliance with low-salt or salt-free diet, diabetic diet), smoking cessation, as well as medication adherence. Access to educational tools (digital media) is provided to all initial program participants. These tools will be updated annually by the rehabilitation team on the recommendations. The platform also offers the possibility of organizing an individual or group remote educational session (videoconference modules allowing group and individual sessions), a secure integrated caregiver-patient messaging system. The control group will receive the usual controls at the hospital.

Discussion: To offer a complete solution of care to our patients, we have thought of setting up a digital platform that aims to monitor the patient and strengthen their abilities to manage their condition daily. This pilot experience could be generalized to several services and disciplines. It could be used in several research works.

Trial registration: Trial registered with the Pan African Clinical Trial Registry (PACTR202307694422939). URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=24247.

Fig 1. The schedule of enrolment, interventions, and assessments *.

*Recommended content can be displayed using various schematic formats. See SPIRIT 2013 Explanation and Elaboration for examples from protocols. **List specific timepoints in this row.