Randomized Multicenter Clinical Trial of the Efficacy of a Telemedicine Monitoring in the Management of a Depressive Episode After an Hospitalisation in Medicine or Surgery

Official Summary

Major depressive disorder (MDD) is a common chronic disease. It is the main cause of morbidity and disability in the world with, among other things, an increase in cardio-metabolic risk and a reduction in life expectancy, regardless of suicide risk. MDD is the most expensive medical condition: 10-20 billion €/year in France. This cost is mainly attributable to the functional consequences of the disease, highlighting the medico-economic challenge represented by the optimization of the organization of care. In France, more than 80% of MDD patients are enrolled in non-psychiatric care pathways, mainly primary care or MSO hospital care (medicine, surgery, obstetrics). Unfortunately, less than half of patients benefit from treatment at an appropriate dosage or duration, thus exposing them to the risks of relapse, recurrence and chronic evolution. It is necessary to optimize this management, in particular by improving secondary prevention, which consists of maintaining treatment in the months following symptomatic remission. Several support programs (monitoring with assessment of symptomatology) have shown their effectiveness on depressive symptomatology with a favorable medico-economic report, in particular by allowing maintenance of antidepressant treatment. None of these studies have been conducted on French care pathways. Investigators propose to evaluate the efficacy of telemedicine management (added to usual care) in non-psychiatric care pathways on the evolution of depressive symptomatology for MDD patients. Investigators hypothesize that telemedicine monitoring downstream of MSO hospitalization will increase the response rate to antidepressants at 6 months and reduce the costs attributed to depressive symptoms compared to usual care, in particular by optimizing secondary prevention strategies by maintaining treatment. The main objective of the research is to assess the efficacy of telemedicine monitoring on depressive symptoms and treatments, added to the out-

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 836 participants

Interventions

• BEHAVIORAL: Telemedicine session — The content of telemedicine session is semi-standardized and includes: (1) evaluation of the tolerance and efficacy of drug treatment; (2) evaluation of depressive symptoms (PHQ9 scale); (3) identification of the daily difficulties; (4 ) personalized advice and orientation towards appropriate care pathways. Among the personalized advice, investigators will use the digital tools available to maintain remission, psychoeducation and monitoring tools (for example, application to learn mindfulness me

Primary Outcomes

• Treatment response rate at 6 months after inclusion. (At 6 months)

Secondary Outcomes

• Incremental cost-utility ratio over the 3 years of follow-up (At inclusion, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months)
• Incremental cost-utility ratio over the 3 years of follow-up (A inclusion, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months)
• Quality of life score (A inclusion, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months)
• Quality of life score (At inclusion, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months)
• Number of relapse episodes for the improvement of secondary prevention objective (At inclusion, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months)

Trial Locations

• Hôpital Pitié Salpêtrière, Paris, France

More Major Depressive Disorder Trials

View all Major Depressive Disorder clinical trials