Health Care Use and Costs of Functional Somatic Disorders

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05811663
• Other study ID #: DanFunD direct healthcare
• Status: Completed
• Start date: November 10, 2011
• Est. completion date: August 30, 2015

Study information

• Verified date: March 2023
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9656
• Est. completion date: August 30, 2015
• Est. primary completion date: June 30, 2015
• Gender: All
• Age group: 18 Years to 76 Years

Eligibility

Inclusion Criteria:

• None

Exclusion Criteria:

• not born in Denmark

• not being a Danish citizen

• pregnancy.

Related Conditions & MeSH terms

• Bodily Distress Syndrome
• Chronic Fatigue Syndrome
• Chronic Widespread Pain
• Fatigue Syndrome, Chronic
• Fibromyalgia
• Irritable Bowel
• Syndrome

Locations

Country	Name	City	State
Denmark	Marie Weinreich Petersen	Aarhus N

Sponsors (2)

Lead Sponsor	Collaborator
Aarhus University Hospital	Center for Clinical Research and Prevention, Bispebjerg and Frederiksberg Hospital, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use of primary healthcare resources 10 years before baseline	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.	10-year period before the day the participant participated in the DanFunD baseline investigation
Primary	Costs of primary healthcare resources 10 years before baseline	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.	10-year period before the day the participant participated in the DanFunD baseline investigation
Primary	Use of primary healthcare resources 4 years after baseline	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.	4-year period after the day the participant participated in the DanFunD baseline investigation
Primary	Costs of primary healthcare resources 4 years after baseline	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.	4-year period after the day the participant participated in the DanFunD baseline investigation
Primary	Use of secondary healthcare resources 10 years before baseline	Data on use of healthcare in secondary care will be extracted from the National Patient Registry.	10-year period before the day the participant participated in the DanFunD baseline investigation
Primary	Costs of secondary healthcare resources 10 years before baseline	Data on costs of healthcare in secondary care will be extracted from the National Patient Registry.	10-year period before the day the participant participated in the DanFunD baseline investigation
Primary	Use of secondary healthcare resources 4 years after baseline	Data on use of healthcare in secondary care will be extracted from the National Patient Registry.	4-year period after the day the participant participated in the DanFunD baseline investigation
Primary	Costs of secondary healthcare resources 4 years after baseline	Data on costs of healthcare in secondary care will be extracted from the National Patient Registry.	4-year period after the day the participant participated in the DanFunD baseline investigation
Primary	Use of prescription medication 10 years before baseline	Data on number of prescriptions will be extracted from The Danish Register Prescription Sales.	10-year period before the day the participant participated in the DanFunD baseline investigation
Primary	Costs of prescription medication 10 years before baseline	Data on costs of prescriptions will be extracted from The Danish Register Prescription Sales.	10-year period before the day the participant participated in the DanFunD baseline investigation
Primary	Use of prescription medication 4 years after baseline	Data on number of prescriptions will be extracted from The Danish Register Prescription Sales.	4-year period after the day the participant participated in the DanFunD baseline investigation
Primary	Costs of prescription medication 4 years after baseline	Data on costs of prescriptions will be extracted from The Danish Register Prescription Sales.	4-year period after the day the participant participated in the DanFunD baseline investigation