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临床试验/NCT06818227
NCT06818227尚未招募不适用

MonPsyMoi: Etude Des Conditions d'implémentation et de l'Impact de la Plateforme Digitale française de Recueil de l'expérience Patient en Psychiatrie (Modules Avec et Sans " Feedback ")

Assistance Publique Hopitaux De Marseille1 个研究点 分布在 1 个国家目标入组 23,660 人开始时间: 2025年2月2日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
23,660
试验地点
1
主要终点
Relapse at 12 Months

研究概览

简要总结

Mental health disorders, with a 30% annual prevalence rate, are a leading cause of disability and reduced life expectancy. Despite their impact, patient-reported experience measures (PREMs) and outcome measures (PROMs) are underutilized in psychiatry. MonPsy&Moi®, a digital platform funded by ATIH and DGOS, addresses this gap by providing a user-friendly tool to assess patient experiences and outcomes in real-time, aiming to improve the quality of psychiatric care across France.

The study consists of two stages:

Stage 1 (No Feedback): MonPsy&Moi® is deployed across 12 psychiatric facilities, collecting patient data without feedback to clinicians. Objectives include assessing implementation feasibility, validating adaptive questionnaires (PREMIUM), and identifying predictors of patient outcomes, such as relapse and healthcare utilization.

Stage 2 (With Feedback): Focuses on patients with severe mental illnesses (schizophrenia, bipolar disorders, and major depressive disorders). This stage evaluates the impact of providing PREMs/PROMs feedback to clinicians on relapse rates, healthcare costs, and overall patient outcomes.

MonPsy&Moi® uses adaptive questionnaires tailored to psychiatric care, covering key domains such as dignity, information, interpersonal relationships, care environment, and treatment. It also evaluates health-related quality of life, including psychological well-being, autonomy, self-esteem, and social relationships. The platform integrates with national healthcare databases (SNDS) to enhance data analysis and predict patient trajectories.

The study will involve over 22,000 participants in Stage 1 and 1,100 participants in Stage 2, using a quasi-experimental design to compare feedback and non-feedback strategies. Results aim to demonstrate the feasibility, acceptability, and efficacy of MonPsy&Moi® in improving mental health outcomes and guiding national psychiatric care policies.

By empowering patients and clinicians with actionable insights, MonPsy&Moi® aspires to set a new standard for patient-centered mental healthcare in real-world settings

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Residing in France. Age between 18 and 65 years at the time of inclusion.
  • Receiving care in one of the 12 participating psychiatric facilities, with a confirmed diagnosis of:
  • Schizophrenia Spectrum Disorders (e.g., schizophrenia, schizoaffective disorder).
  • Bipolar Disorders. Major Depressive Disorders. A valid email address. Ability to read and understand French. Non-opposition to participating in the study (based on informed consent).

排除标准

  • Primary diagnosis of an organic mental disorder, including:
  • Dementia. Stroke. Traumatic brain injury. Individuals deprived of liberty by judicial decision (e.g., incarcerated patients).

结局指标

主要结局

Relapse at 12 Months

时间窗: within 12 months

Relapse is defined as one or more of the following events occurring within 12 months:Full-time psychiatric hospitalization, Psychiatric emergency care. Hospitalization due to a suicide attempt, Death.

次要结局

  • Cost-Effectiveness Analysis(12 months post-inclusion)
  • Impact of Feedback on healthcare resource utilization(6 and 12 months post-inclusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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