Remote Medical Monitoring of Patients With Depression

Condition(s) studied

Investigational drug(s) / intervention(s)

Use of ThIA Medical Device: As soon as the patient has provided free and informed consent, signed it, he or she will be randomized and assigned to one of the two study arms: standard care combined with ThIA Suivi remote medical monitoring, or standard care alone. Regardless of which randomization arm he or she is assigned to, the patient will receive optimal care. The patient in this arm will have access to the "ThIA Suivi" remote medical monitoring system starting the days following their medical consultation with the psychiatrist and throughout his/her participation in the study, in addition to his/her usual standard of care. The patient will have access to all the features of the ThIA Suivi app, including personalized therapeutic education, standardized questionnaires to assess mental health, an alert and notification system, as well as monitoring of side effects and treatment adherence. This system will enable real-time monitoring of symptom progression, allowing the psychiatrist to intervene quickly.

Study summary

The goal of this clinical trial is to learn if ThIA Suivi, a digital tool for remote monitoring of patients, can improve the care of adults with depression who are followed by a psychiatrist.

The main question it aims to answer is:

\* Does using ThIA Suivi in addition to usual psychiatric care increase the proportion of patients whose depression symptoms have clearly improved after 3 months, compared with usual care alone? (Improvement is measured with a questionnaire on depression symptoms, the PHQ-9, and is defined as a drop of at least 5 points from the starting score.)

Researchers will compare patients who use ThIA Suivi with patients who receive usual care only, to see if ThIA Suivi leads to a greater improvement in symptoms. The researchers' hypothesis is that patients using ThIA Suivi will do better. \[

Participants will:

* Continue to be followed by their psychiatrist as usual.
* Use ThIA Suivi or will receive usual care only
* Complete questionnaires about their symptoms at 3 months, 6 months and 12 months.
* Be followed for 12 months.

Why is this study needed? Depression is a common mental health condition. It causes lasting sadness, loss of interest in everyday activities, and low energy. About 280 million people worldwide live with depression. It affects daily life, work, and relationships, and it can come back: more than half of people who have one episode will have another.

Depression is often treated with antidepressant medication. However, after 8 weeks of treatment, only about 1 in 3 people fully recovers. Side effects can appear before the benefits, which can make it hard to keep taking the medication. Close follow-up after treatment starts is therefore important. In practice, the first follow-up visit often happens late (a median of 27 days after the prescription in France). In addition, psychiatrists are not evenly spread across France, and most first antidepressant prescriptions are written by general practitioners.

Digital tools may help patients and health professionals stay in contact between visits. In France, however, no remote monitoring tool for mental health is currently reimbursed by the national health insurance. ThIA Suivi was developed by ThIA Santé Mentale to fill this gap. It is meant to be used within a care pathway supervised by health professionals. The researchers hope that it will improve patients' care, help them stay on track with treatment, and reduce the risk of the depression coming back.

Eligibility

Primary outcome measure(s)

• Number of Participants with A Reduction of 5 Points in PHQ-9 Score — From enrollment to 6 months after
  To evaluate the clinical impact of the ThIA Suivi remote medical monitoring system in the care of patients with depression, compared with standard of care, the primary outcome measure is the proportion of patients who responded to treatment at 3 months. Response to treatment is defined by the presence of: a significant improvement, defined as a reduction of at least 5 points in the PHQ-9 score compared to the baseline score. The 5-point threshold corresponds to the Minimal Clinically Important Difference (MCID).

Trial sites (3)

Other trials for the same condition