Patient-reported Outcome Measures (PROMs) as Characteristics and Prognostic Factors in Patients With Bodily Stress Syndrome: Protocol for a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Self-rated global health improvement
研究概览
简要总结
This cohort study implements patient reported outcome measures (PROMs) for patients with bodily stress syndrome in a clinic for functional disorders.
详细描述
The Sympa Cohort study is a prospective, single site cohort study that consists of administration of PROMs questionnaires to patients that attend the Clinic for Functional Disorders at Helsinki University hospital (HUS). The questionnaires are handed out to the study population within seven days before their first visit at the clinic, and then at the following 3, 6 and 12 months. The study population consists of consecutive adult patients that are referred to the clinic either from other hospital units or primary care. The collected data will later be linked with national registries on diagnoses, medication use and work ability. The Sympa Cohort study may have implications in targeting the factors influencing functional outcomes and quality of life reported by patients with bodily stress syndrome. It will also form a quality register for the Clinic and characterize the first systematic collection of PROMs related to these disorders in Finland.
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 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All genders
- •Age 18-80 years
- •Referred to Clinic for Functional Disorders either from other hospital units or from primary care
- •Willingness to be enrolled in the study, by signing the informed consent
排除标准
- •Patients not able to fill in the forms in Finnish or due to physical constraints (e.g. dystonia)
- •Symptoms are likely due to a somatic disorder
结局指标
主要结局
Self-rated global health improvement
时间窗: 12 months
Measured by clinical improvement scale (clinical global improvement, CGI), a five-point Likert scale
Functional ability
时间窗: 12 months
Measured by WHODAS 2.0
次要结局
- EUROHIS-QOL-8(3, 6 and 12 months)
- RS-14(3, 6 and 12 months)
- PHQ-9(3, 6 and 12 months)
- GAD-7(3, 6 and 12 months)
- 15D(3, 6 and 12 months)
- SSD-12(3, 6 and 12 months)
研究者
Helena Liira
Chief Physician
Helsinki University Central Hospital
