Health Care Use and Costs of Functional Somatic Disorders

NCT05811663 | Completed

• 1 other identifier: DanFunD direct healthcare
• Study Type: observational
• Target: 9,656
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bodily Distress Syndrome; Irritable Bowel; Fibromyalgia; Chronic Widespread Pain; Chronic Fatigue Syndrome

Outcome Measures

Primary Outcomes (12)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

DanFunD baseline

Data from the DanFunD baseline cohort will be included. It comprises a total of 9,656 (33.7% of the invited participants) men and women aged 18-76 years born in Denmark and living in the Western part of greater Copenhagen. Individuals with FSD are identified by means of self-reported questionnaires (n=9,656) and diagnostic research interviews (n=1,590). Participants with FSD will be defined as follows: FSD operationalised by the Bodily Distress Syndrome single- and multi-organ type will be defined with both self-reported questionnaires and diagnostic interviews. Three functional somatic syndromes, i.e. irritable bowel, chronic widespread pain, and chronic fatigue will be defined with questionnaires. Severe physical disease will be defined by means of self-report as having received at least one of the following five diagnoses: Cancer, stroke, myocardial infarction, other heart disease, and obstructive pulmonary disease.

Eligibility Criteria

• Age: 18 Years - 76 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Data from the DanFunD baseline cohort will be included. For this cohort, a total of 25,368 men and women aged 18-72 years living in the Western part of Greater Copenhagen were randomly obtained from the nationwide Danish registries and invited to participate; 9656 accepted. All of them answered questionnaires about physical symptoms, physical and mental health as well as social components. A stratified sub sample consisting og every tenth participant together with every high score on the symptoms questionnaires were invited to participate in a diagnostic interview performed over telephone by trained family physicians. A total of 2450 were invited and 1590 accepted and participated in the interview.

You may qualify if:

• None

You may not qualify if:

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

Sponsors & Collaborators

• Aarhus University Hospital: lead
• University Hospital Bispebjerg and Frederiksberg: collaborator

Study Sites (1)

Marie Weinreich Petersen

Aarhus N, 8200, Denmark

Location

Related Publications (1)

• Petersen MW, Wellnitz KB, Oernboel E, Carstensen TBW, Meinertz Dantoft T, Ahrendt Bjerregaard A, Joergensen T, Fink P. Healthcare use and costs of functional somatic disorder in Denmark: a population-based cohort study (DanFunD). BMJ Public Health. 2025 Dec 17;3(2):e003318. doi: 10.1136/bmjph-2025-003318. eCollection 2025.

  PMID: 41431615 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome; Fibromyalgia; Chronic Pain; Fatigue Syndrome, Chronic

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Encephalomyelitis; Neuroinflammatory Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Study Officials

• Per W Fink, DMSc

  Aarhus University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: April 13, 2023
• Study Start: November 10, 2011
• Primary Completion: June 30, 2015
• Study Completion: August 30, 2015
• Last Updated: April 13, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)