About this trial
The goal of this superiority clinical investigation, prospective, multicenter, controlled, randomized, open-label is to evaluate the clinical impact of the Dalia medical telemonitoring device on the management of depressive patients. The main question it aims to answer is: the percentage of patients with clinically significant improvement at 3 months. A clinically significant improvement is defined as a decrease of at least 5 points from the initial PHQ-9 score AND/OR a PHQ-9 score lower than 15. The threshold of 5 points is the Minimal Clinically Important Difference (MCID) of the PHQ-9 scale
Eligibility criteria
Qualifiers
Age ≥ 18 years
Patient with a diagnosis of depressive episode, as defined by ICD-11, and with a PHQ-9 score ≥ 15 confirmed by a psychiatrist or general practitioner
Patient receiving a first antidepressant treatment (treatment-naïve) OR having had a modification of antidepressant treatment in the two weeks prior to inclusion
Patient equipped with a smartphone or a computer or a tablet with internet access
Disqualifiers
Patient under non-cardioselective beta-blocker (carvedilol, labetalol, propranolol, pindolol) and beta-mimetic (salbutamol, terbutaline)
Patient with a pacemaker or with a known cardiac arrhythmia
Patient with major neurocognitive disorder (e.g., dementia) or psychotic disorders likely to compromise participation in the study
Patient hospitalized at the time of inclusion whose discharge is not planned within the next two weeks
Trial design
Treatments tested in this trial
- Dalia Monitoring
- Conventional healthcare