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Completed

NCT Number: NCT05811663

Health Care Use and Costs of Functional Somatic Disorders

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.

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Key information

Conditions

Bodily Distress Syndrome Chronic Disease Chronic Fatigue Syndrome Chronic Pain Chronic Widespread Pain Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Disease Attributes Encephalomyelitis Fatigue Syndrome, Chronic Fibromyalgia Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Irritable Bowel Syndrome Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuroinflammatory Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year–76 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Marie Weinreich Petersen

Aarhus N, 8200, Denmark

About this study

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

  • individuals without FSD, and
  • individuals with severe physical disease

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • None

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Use of primary healthcare resources 10 years before baseline

    Time frame: 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.

  2. Costs of primary healthcare resources 10 years before baseline

    Time frame: 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.

  3. Use of primary healthcare resources 4 years after baseline

    Time frame: 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.

  4. Costs of primary healthcare resources 4 years after baseline

    Time frame: 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.

  5. Use of secondary healthcare resources 10 years before baseline

    Time frame: 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.

  6. Costs of secondary healthcare resources 10 years before baseline

    Time frame: 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.

  7. Use of secondary healthcare resources 4 years after baseline

    Time frame: 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.

  8. Costs of secondary healthcare resources 4 years after baseline

    Time frame: 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.

  9. Use of prescription medication 10 years before baseline

    Time frame: 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.

  10. Costs of prescription medication 10 years before baseline

    Time frame: 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.

  11. Use of prescription medication 4 years after baseline

    Time frame: 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.

  12. Costs of prescription medication 4 years after baseline

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Collaborators

  • University Hospital Bispebjerg and Frederiksberg

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Apr 13, 2023
Registry last updated
Apr 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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