Effectiveness of a Joint Crisis Plan (SOS Plan) in Preventing Relapses in Patients Diagnosed With Schizophrenia and Schizoaffective Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 124
- 试验地点
- 4
- 主要终点
- incidence of the first psychiatric hospitalisation
研究概览
简要总结
The Joint Crisis Plan = SOS Plan is a reference to a particular form of psychiatric advance directive which involves the patient, the healthcare team, their relatives and a third party caregiver as intermediary for the project.
The main objective is to evaluate the effectiveness of the SOS Plan (JCP) in terms of the reduction in hospitalisations within 18 months of its development by comparison to the standard psychiatric care.
Thus, the investigators' proposal is that SOS Plan's are regularly reassessed every 6 months and again where there is an unplanned psychiatric readmission that lasts beyond two weeks.
Single blind multicentre randomised trial with parallel control groups.
Effectiveness study of a psychiatric care strategy.
详细描述
Single blind multicentre randomised trial with parallel control groups.
2 groups:
- SOS Intervention Group: benefits from the SOS Plan in addition to the usual follow-ups
- "Control" Group: receive no additional intervention (only receive the routine follow-ups)
OBJECTIVES :
- To evaluate the effectiveness of the SOS Plan (JCP) in terms of the reduction in hospitalisations within 18 months of its development by comparison to the standard psychiatric care
- To evaluate :
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- 否
入选标准
- •Aged between 18 and 65 years
- •Diagnosed with schizophrenia or schizoaffective disorder according to criteria specified in DSM
- •Psychiatric inpatient or an outpatient with a specialised framework of psychiatric follow-ups
- •Patient has been hospitalised at least once in a psychiatric department within the previous 2 years
- •Adults under protective measures can be included (guardianship/supervision). Consent will also be sought from the guardian or trusted person.
- •Registered for social security
排除标准
- •Refusal to participate in the study
- •Unable to give his or her written consent
- •Patients detained
- •Pregnant or lactating women
结局指标
主要结局
incidence of the first psychiatric hospitalisation
时间窗: 18 months
the incidence of the first psychiatric hospitalisation within 18 months following inclusion
次要结局
- SF-36 quality of life(every 6 months during 2 years)
- medical cost(every 6 months during 2 years)
- types of psychiatric hospitalisations(2 years)
- cumulative time in days of psychiatric hospitalisations(2 years)
- number of hospitalisations(2 years)
- number of emergency psychiatric consultations(2 years)
- clinical assessment by the PANSS scale(every 6 months during 2 years)
- Working Alliance Inventory(every 6 months during 2 years)
- length of the meeting to develop the SOS Plan(every 6 months during 2 years)
- Autonomy Preference Index(every 6 months during 2 years)
- patient satisfaction(every 6 months during 2 years)