SUR-CL3R-PEPS, CH Vinatier, Bron, Rhône-Alpes, France
PSYR2 Team, INSERM U1028, CNRS UMR5292, Lyon Neuroscience Research Center, Université Claude Bernard Lyon 1, Lyon, France, Lyon, France.
BMJ Open. 2021 Sep 14;11(9):e050433. doi: 10.1136/bmjopen-2021-050433.
The prognosis of first episode psychosis (FEP), which is a severe disorder, can be notably impaired by patients' disengagement from healthcare providers. Coordinated specialty care with case management is now considered as the gold standard in this population, but there are still challenges for engagement with subsequent functional impairments. Youth-friendly and patient-centred clinical approaches are sought to improve engagement in patients with FEP. Mobile applications are widely used by young people, including patients with FEP, and can increase the youth friendliness of clinical tools. We hypothesise that a co-designed mobile application used during case management can improve functioning in patients with FEP as compared with usual case management practices.
A mobile case management application for planning and monitoring individualised care objectives will be co-designed with patients, caregivers and health professionals in a recovery-oriented approach. The application will be compared with usual case management practices in a multicentre, two-arm and parallel groups clinical trial. Patients will be recruited by specialised FEP teams. Impact on functioning will be assessed using the Personal and Social Performance Scale; the variation between baseline and 12 months in each group (control and active) will be the primary outcome.
This study has been approved by the Inserm Institutional Review Board IRB00003888 (Comité d'évaluation éthique de l'INSERM, reference number 20-647). The results of the study will be published in a peer-reviewed journal and presented at national and international conferences. We will also communicate the results to patients and family representatives' associations. An optimised version of the application will be then disseminated through the French FEP network (Transition Network).
ClinicalTrials.gov: NCT04657380.
首次发作精神病（FEP）是一种严重的疾病，患者与医疗保健提供者脱节会显著影响其预后。目前，为该人群提供协调的专科护理和病例管理被认为是金标准，但在后续功能障碍的参与方面仍存在挑战。为了改善 FEP 患者的参与度，人们正在寻求对年轻人友好和以患者为中心的临床方法。移动应用程序在年轻人中得到广泛应用，包括 FEP 患者，并且可以提高临床工具的对年轻人的友好程度。我们假设，与常规病例管理实践相比，在病例管理期间使用共同设计的移动应用程序可以改善 FEP 患者的功能。
将以康复为导向的方法与患者、护理人员和卫生专业人员共同设计一款用于规划和监测个性化护理目标的移动病例管理应用程序。该应用程序将在一项多中心、双臂和平行组临床试验中与常规病例管理实践进行比较。患者将由专门的 FEP 团队招募。使用个人和社会表现量表评估功能的影响；每个组（对照组和实验组）的基线和 12 个月之间的变化将是主要结果。
这项研究已经得到了法国国家健康与医学研究院伦理审查委员会（Inserm Institutional Review Board IRB00003888）的批准（Comité d'évaluation éthique de l'INSERM，参考号 20-647）。研究结果将在同行评议的期刊上发表，并在国内和国际会议上展示。我们还将向患者和家属代表协会传达研究结果。然后，将通过法国 FEP 网络（Transition Network）传播优化后的应用程序版本。
ClinicalTrials.gov：NCT04657380。
