Clinical trial NCT06076317: Relevance of a Telemedicine Monitoring in the Management of Depression
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Characterized depressive disorder
Telemedicine session
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 836
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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-of-hospital downstream care pathways for patients initially hospitalized in MSO (medicine-surgery-obstetrics), compared to usual care.

Detailed description: Major depressive disorder (MDD) is a common and often chronic disease. It is the main cause of morbidity and disability in the world with, among other things, an increase in cardio-metabolic risk (diabetes, cardiovascular diseases, high blood pressure) 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-of-hospital downstream care pathways for patients initially hospitalized in MSO (medicine-surgery-obstetrics), compared to usual care.

This is a randomized multicenter clinical trial with two parallel arms concerning a population of MDD patients downstream of an MSO hospitalization evaluating the interest of monitoring by telemedicine of the symptoms and treatments, added to out-of-hospital downstream care pathways compared to usual care. One arm consists in usual care and the other one in usual care + telemedicine monitoring. Included patients will be followed for 3 years, the main endpoint will be the clinical efficacy at 6 months from the start of treatment, as the percentage of patients in remission from depressive symptoms (a reduction in the HADS-depression scale score of 50% or more).

Inclusion is made during MCO hospitalization by the liaison psychiatrist. Will be included patients suffering from a MDD with the indication of antidepressant treatment.

The initial psychometric assessment includes the MINI to verify diagnostic criteria for MDD and the HADS to measure the severity of depressive symptoms. The participants are randomized into two groups: "Usual care + tele-monitoring (UC-Plus)" and "Usual care (UC)".

The "UC" group will follow the care prescribed by the liaison psychiatrist during their hospitalization. Each patient will also receive the contact details of his/her medico-psychological center.

The "UC-Plus" group will follow usual care and benefit from telemedicine sessions led by a nurse/psychologist working under the supervision of a psychiatrist. These sessions follow a standardized protocol with 4 evaluations (maximum duration of 20 minutes): (1) evaluation of the tolerance and efficacy of the psychotropic treatment; (2) assessment of depressive symptoms (PHQ-9 scale); (3) identification of daily difficulties; (4) therapeutic orientation and recommendation. A standardized report (score, evolutionary curve, etc.) validated by a psychiatrist will be sent to the patient and his treating physicians (general practitioner, psychiatrist, oncologist, other). The frequency of sessions is defined by the clinical symptomatology:

* Initially: weekly frequency until response to treatment (reduction of PHQ-9 score\>50%)
* After response to treatment: variable frequency (weekly to monthly) decided with the patient until remission (score PHQ-9\<5)
* After remission: monthly frequency for 6 months, then end of intervention. An increase in the session frequency is possible in the case of relapse or recurrence.

Evaluations at 3, 6, 12, 18, 24, 30 and 36 months, relating to HADS and medico-economic variables, will be carried out in the 2 arms, by telephone blinded to group membership by a technician clinical study. In the event of a high suicide risk, the patient is referred urgently to appropriate care.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Presence of DSM5 criteria for the diagnosis of a characterized depressive episode
* Patient hospitalized in MCO with request for liaison psychiatry opinion whatever the hospitalization modality (full hospitalization, weekday hospitalization or day hospitalization)
* Initiation, change of molecule or modification of a psychotropic treatment (antidepressant or anxiolytic) during MCO hospitalization by the liaison psychiatrist
* Affiliated or entitled to a social security system (except AME)
* Obtaining free, written and informed consent

Exclusion Criteria:

* Severity of the depressive episode incompatible with outpatient care and relevant to an indication for hospitalization in psychiatry
* Patient is part of a psychiatric care program at the time of the selection visit
* Presence of a mood disorder other than CDD
* Reason for MCO hospitalization secondary to psychiatric disorders, in particular suicide attempts
* MCO hospitalization prolonged beyond 3 weeks after initiation, change of molecule or modification of psychotropic treatment dosage
* Psychiatric comorbidities assessed by psychiatrist, in particular addictions (excluding tobacco), delusional disorders, post-traumatic stress disorder, anxiety disorders (excluding GAD)
* High suicidal risk at the screening visit assessed by psychiatrist
* Presence of a non-psychiatric condition with a vital prognosis of less than 3 years
* Contraindications to telemedicine (no internet access, major vision problems, major cognitive problems, marked impulsivity, clinical situation requiring information to be communicated in person, etc.)
* Conditions making consent impossible (major cognitive disorders, etc.)
* Deprived of liberty or under a protective measure (guardianship or under curatorship)
* Pregnant woman
* Refusal of the patient

Primary outcomes:
measure: Treatment response rate at 6 months after inclusion.
timeFrame: At 6 months
Secondary outcomes:
measure: Incremental cost-utility ratio over the 3 years of follow-up
timeFrame: At inclusion, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months
measure: Incremental cost-utility ratio over the 3 years of follow-up
timeFrame: A inclusion, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months
measure: Quality of life score
timeFrame: A inclusion, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months
measure: Quality of life score
timeFrame: At inclusion, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months
measure: Number of relapse episodes for the improvement of secondary prevention objective
timeFrame: At inclusion, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months
measure: Medication compliance and integration into a psychiatric care pathway
timeFrame: At inclusion, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months
measure: Medication compliance and integration into a psychiatric care pathway
timeFrame: At inclusion, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months
measure: Medication compliance and integration into a psychiatric care pathway
timeFrame: At inclusion, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months
measure: Medication compliance and integration into a psychiatric care pathway
timeFrame: At inclusion, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months
measure: Therapeutic efficacy
timeFrame: At 36 months
measure: Evaluation of the feasibility and satisfaction of telemedicine tools by patients included in the experimental group
timeFrame: At inclusion, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months
measure: Evaluation of the feasibility and satisfaction of telemedicine tools by patients included in the experimental group
timeFrame: At inclusion, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months
measure: Evaluation of the satisfaction of depression care
timeFrame: At inclusion, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months
measure: Clinical variables associated with drop out of the care program
timeFrame: At inclusion, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months
measure: Clinical variables associated with drop out of the care program
timeFrame: At inclusion, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months
measure: Clinical variables associated with drop out of the care program
timeFrame: At inclusion, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months
measure: Clinical variables associated with drop out of the care program
timeFrame: At inclusion, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months
measure: Clinical variables associated with drop out of the care program
timeFrame: At inclusion, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months
measure: Clinical variables associated with drop out of the care program
timeFrame: At inclusion, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months
measure: Clinical variables associated with drop out of the care program
timeFrame: At inclusion, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months
measure: Measurement of stigma scale scores and subscores in each group
timeFrame: At inclusion and 6 months
measure: Evaluation of the possibility of the physicians to require a psychiatric opinion on the care
timeFrame: At inclusion, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months
measure: Identification of the use of NICT tools (New Information and Communication technologies)
timeFrame: At inclusion, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months
measure: Frequency of the use of NICT tools (New Information and Communication technologies)
timeFrame: At inclusion, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Pitié Salpêtrière
Study officials:
affiliation: Hôpital Pitié Salpêtrière - Assistance Publique Hôpitaux de Paris
name: Jean Yves ROTGE, Pr
role: PRINCIPAL_INVESTIGATOR
References: