Bodily Distress SyndromeNCT05811663
Health Care Use and Costs of Functional Somatic Disorders
An observational study of Bodily Distress Syndrome and Irritable Bowel, run by Aarhus University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 76 years
- Conditions the study is for
- Bodily Distress Syndrome, Irritable Bowel, Fibromyalgia
- How many people
- 9,656 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Nov 2011to 30 Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 76 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- None
Who cannot join
- not born in Denmark
- not being a Danish citizen
- pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Health Care Use and Costs of Functional Somatic Disorders: A Population-based Study (DanFunD)
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.
Read the detailed 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
- individuals without FSD, and
- individuals with severe physical disease
- Conditions
- Bodily Distress Syndrome, Irritable Bowel, Fibromyalgia, Chronic Widespread Pain, Chronic Fatigue Syndrome
- Medical subject headings
- Irritable Bowel Syndrome, Fibromyalgia, Chronic Pain, Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4-year period after the day the participant participated in the DanFunD baseline investigation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start10 Nov 2011
- Primary completion30 Jun 2015
- Study completion30 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bodily Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 9,656 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Bispebjerg and Frederiksberg
- Responsible party
- Sponsor
- Investigators
- Per W Fink, DMSc, Study chair, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05811663
- Sponsor's protocol ID
- DanFunD direct healthcare
- Status last verified
- Mar 2023
- First submitted
- 2 Mar 2023
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41431615
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Care Use and Costs of Functional Somatic Disorders: A Population-based Study (DanFunD)
- ClinicalTrials.gov ID
- NCT05811663
- Acronym / sponsor ID
- DanFunD direct healthcare
- Conditions
- Bodily Distress Syndrome, Irritable Bowel, Fibromyalgia, Chronic Widespread Pain, Chronic Fatigue Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,656 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- University Hospital Bispebjerg and Frederiksberg
- Study start
- 10 Nov 2011 (actual)
- Primary completion
- 30 Jun 2015 (actual)
- Study completion
- 30 Aug 2015 (actual)
- First posted
- 13 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- individuals without FSD, and
- individuals with severe physical disease
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- None
Key exclusion criteria (3 listed)
- not born in Denmark
- not being a Danish citizen
- pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Derived from this study: PubMed 41431615Petersen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per W Fink, DMSc study chair
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bodily Distress Syndrome and Irritable Bowel, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05811663, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.