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临床试验/NCT05811663
NCT05811663已完成不适用

Health Care Use and Costs of Functional Somatic Disorders: A Population-based Study (DanFunD)

Aarhus University Hospital1 个研究点 分布在 1 个国家目标入组 9,656 人开始时间: 2011年11月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
9,656
试验地点
1
主要终点
Use of primary healthcare resources 10 years before baseline

研究概览

简要总结

The goal of this observational case-control study is to learn about direct healthcare use and costs of functional somatic disorders.

The aim of the proposed study is to investigate the use and costs of direct healthcare for individuals with functional somatic disorders.

Researchers will compare direct healthcare use and costs of individuals with functional somatic disorders and compare them with that of healthy controls and individuals with other severe physical disease, respectively.

详细描述

Functional somatic disorders (FSD) are common conditions characterized by persistent patterns of physical symptoms that cannot be better explained by other physical or mental conditions. The conditions may cause severe impairment for the patients who are often characterized by impaired physical and mental health, lower social status, and poor labour market association.

In 2005, it was estimated that FSD accounted for 3% of hospitalizations and 10-20% of health care expenses in Denmark, and a newer Danish primary care study has shown patients with FSD to have higher annual health care costs compared with conventionally-defined conditions. In foreign nations, studies in clinical samples have shown increased direct and indirect health care costs of FSD which showed a dose-response relationship with severity of the FSD. One Canadian population-based study found increased health care use and costs in children, adolescents, and young adults with a first health record diagnosis of somatic symptom and related disorders. Even though these previous studies provide valuable knowledge to the field of FSD, their methodology may give rise to bias, i.e. inclusion of highly selected patient samples, the use of various diagnostic criteria for defining FSD, and the establishment of FSD by means of self-report. Evidently, studies investigating the socioeconomic burden in terms of direct health care use and costs of FSD in a randomly obtained population-based sample using solid methodology such as validated symptom criteria and diagnostic interviews for establishing FSD are highly lacking.

The objectives of this proposed study are:

To describe and investigate the healthcare use and healthcare costs for individuals with FSD and compare them with

  1. individuals without FSD, and
  2. individuals with severe physical disease

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 76 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • not born in Denmark
  • not being a Danish citizen
  • pregnancy.

结局指标

主要结局

Use of primary healthcare resources 10 years before baseline

时间窗: 10-year period before the day the participant participated in the DanFunD baseline investigation

Data on use of healthcare in primary care will be extracted from the Danish National Health Service Register for Primary Care. This category will include number of face-to-face consultations in general practise, medical specialists, physiotherapists, chiropractors, and psychologists.

Costs of primary healthcare resources 10 years before baseline

时间窗: 10-year period before the day the participant participated in the DanFunD baseline investigation

Data on costs of healthcare in primary care will be extracted from the Danish National Health Service Register for Primary Care. This category will include number of face-to-face consultations in general practise, medical specialists, physiotherapists, chiropractors, and psychologists.

Costs of primary healthcare resources 4 years after baseline

时间窗: 4-year period after the day the participant participated in the DanFunD baseline investigation

Data on costs of healthcare in primary care will be extracted from the Danish National Health Service Register for Primary Care. This category will include number of face-to-face consultations in general practise, medical specialists, physiotherapists, chiropractors, and psychologists.

Use of secondary healthcare resources 4 years after baseline

时间窗: 4-year period after the day the participant participated in the DanFunD baseline investigation

Data on use of healthcare in secondary care will be extracted from the National Patient Registry.

Use of primary healthcare resources 4 years after baseline

时间窗: 4-year period after the day the participant participated in the DanFunD baseline investigation

Data on use of healthcare in primary care will be extracted from the Danish National Health Service Register for Primary Care. This category will include number of face-to-face consultations in general practise, medical specialists, physiotherapists, chiropractors, and psychologists.

Costs of secondary healthcare resources 10 years before baseline

时间窗: 10-year period before the day the participant participated in the DanFunD baseline investigation

Data on costs of healthcare in secondary care will be extracted from the National Patient Registry.

Use of prescription medication 10 years before baseline

时间窗: 10-year period before the day the participant participated in the DanFunD baseline investigation

Data on number of prescriptions will be extracted from The Danish Register Prescription Sales.

Costs of prescription medication 10 years before baseline

时间窗: 10-year period before the day the participant participated in the DanFunD baseline investigation

Data on costs of prescriptions will be extracted from The Danish Register Prescription Sales.

Use of secondary healthcare resources 10 years before baseline

时间窗: 10-year period before the day the participant participated in the DanFunD baseline investigation

Data on use of healthcare in secondary care will be extracted from the National Patient Registry.

Use of prescription medication 4 years after baseline

时间窗: 4-year period after the day the participant participated in the DanFunD baseline investigation

Data on number of prescriptions will be extracted from The Danish Register Prescription Sales.

Costs of secondary healthcare resources 4 years after baseline

时间窗: 4-year period after the day the participant participated in the DanFunD baseline investigation

Data on costs of healthcare in secondary care will be extracted from the National Patient Registry.

Costs of prescription medication 4 years after baseline

时间窗: 4-year period after the day the participant participated in the DanFunD baseline investigation

Data on costs of prescriptions will be extracted from The Danish Register Prescription Sales.

次要结局

未报告次要终点

研究者

发起方
Aarhus University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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