Interest of the Tool: Evaluation of Specific Care in an Ecological Environment for Patients Suffering From Schizophrenia-like Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Correlation coefficient between the total ecological questionnaire (ESSME) score and the total score of the social autonomy scale.
研究概览
简要总结
The study use a new ecological questionnaire called ESSME developed by a care team in order to evaluate ecological environment of patients with schizophrenia-like disorders.
Indeed, evaluation in an ecological environment would make it possible to be as close as possible to the concerns of theses patients, which could improve the care of this population, by making it possible to set with the patient objectives anchored in their daily life.
详细描述
The duration of patient's participation to the study is 6 months plus 7 to 14 days.
The study includes the following visits :
- V0: Inclusion visit (Day 0) with the administration of standard of care questionnaires;
- V1: visit at patient's home (Day 0 +7 to 14 days) with the administration of the experimental ESSME questionnaire;
- V2: follow-up visit at 6 months (M6) with the administration of the same standard of care questionnaires than at the inclusion visit;
- V3: visit at patient's home (M6 + 7 to 14 days) with the administration of the experimental ESSME questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •man or woman aged 18 to 65 inclusive;
- •diagnosis of schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders version number 5 (DSM-V) criteria;
- •patient receiving care in a Center for Rehabilitation and Intersectoral Therapeutic Activities (CREATIV);
- •person who consented to the study;
- •affiliate or beneficiary of a social security scheme.
排除标准
- •patient aged under 18 or over 65;
- •pregnant or breastfeeding women;
- •person unable or unwilling to receive a home visit;
- •person not consenting to the study;
- •presence of a diagnosis of an associated neurodevelopmental disorder;
- •presence of a diagnosis of dementia or associated neurodegenerative process;
- •person with a level of French language insufficient to understand the items.
结局指标
主要结局
Correlation coefficient between the total ecological questionnaire (ESSME) score and the total score of the social autonomy scale.
时间窗: 6 months
The main judgment criterion is the correlation coefficient between the change in the total ESSME score and the change in the total score of the selected autonomy scale, the EAS over a period of 6 months. The judgment criterion will be obtained by calculating a percentage variation between the initial total score and that obtained at 6 months for each of the scales: EAS and for the ESSME tool.
次要结局
未报告次要终点