Psychometric Validation of an Oral Health-related Scale for Quality of Life and Coping in People With Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- reliability of scales (internal consistency)
研究概览
简要总结
Schizophrenia is a severe and persistent psychological disorder affecting 0.7 to 1% of the world's population and 600,000 people in France. Schizophrenic patients are exposed to excess mortality and a life expectancy that is 10 to 15 years lower than the general population (excluding causes of suicide) and to numerous co-morbidities, including oral diseases.
To improve this public health problem, concrete action must be undertaken and evaluated in both quantitative and qualitative terms. While there are many quantitative indicators, there are no reliable and valid tools for the perceived oral health of these individuals in the context of their real and/or imagined world.
The results of a qualitative study previously carried out by our team (QUALITY Study: NCT02730832) made it possible to develop two hypothetical questionnaires for evaluating quality of life related to oral health, the Schizophrenia Oral Health Profile (SOHP), and a questionnaire for evaluating coping strategies with regard to oral health, the Schizophrenia Coping Oral Health Profile (SCOOHP).
However, before these questionnaires can be used in clinical practice, their psychometric properties must be validated.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult person,
- •Patients for whom a diagnosis of schizophrenia is defined according to ICD 10
- •Person who has given his or her oral agreement to participate in the study, with the agreement of the tutor in the context of a tutorship,
- •Managed in a Specialised Institution (University Hospital, Psychiatric hospital or Hospital), either in full hospitalisation or on an outpatient basis,
- •Fluent use of the French language.
排除标准
- •Psychiatrically unstable and delusional patients.
- •Patients with cognitive abilities too impaired to participate in the study
- •Individuals with no natural teeth
- •Pregnant or breastfeeding women
- •Patients not affiliated to the national health insurance system.
结局指标
主要结局
reliability of scales (internal consistency)
时间窗: through study completion, an average of 18 months
validity of scales (consistency of responses)
时间窗: through study completion, an average of 18 months
次要结局
未报告次要终点