跳至主要内容
临床试验/NCT04667611
NCT04667611Unknown不适用

Patient-reported Outcome Measures (PROMs) as Characteristics and Prognostic Factors in Patients With Bodily Stress Syndrome: Protocol for a Prospective Cohort Study

Helsinki University Central Hospital1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2020年3月9日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Helena Liira

Chief Physician

Helsinki University Central Hospital

研究点 (1)

Loading locations...

相似试验

Patient-reported Outcome Measures (PROMs) in... | 临床试验