Clinical trial NCT05611606: Welfare Benefits in Functional Somatic Disorders
Official title: Welfare Benefits for Individuals With Functional Somatic Disorders: DanFunD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibromyalgia
Irritable Bowel Syndrome
Chronic Fatigue Syndrome
Bodily Distress Syndrome
Somatoform Disorders
Medically Unexplained Syndrome
Medically Unexplained Symptoms
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Center for Clinical Research and Prevention
First posted: 2022-11-10
Enrollment: 9656
Sex: ALL
Minimum age (years): 18
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Participants were randomly drawn from the adult general Danish population by means of the the Danish Civil Registration system.

The DanFunD baseline cohort comprises a total of 9,656 (33.7% of invited participants) men and women aged 18-76 years, born in Denmark, and living in the Western part of greater Copenhagen. All participants filled in questionnaires regarding physical symptoms and psychological factors, among others. A stratified subsample (n=2,450) of every tenth participant and every symptom high score participant on the DanFunD baseline symptom questionnaires were invited to participate in a diagnostic interview, the Research Interview for Functional somatic Disorders (RIFD), performed by trained family physicians (28); 1,590 (64.9%) accepted and participated in the interview.

Brief summary: The objective of this observational study is to estimate the number of weeks of welfare benefits, i.e. sickness benefit, unemployment benefit and social assistance, for individuals with functional somatic disorders and compare them to

1. healthy individuals, and
2. individuals with severe physical disease.

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 (1). The conditions may cause severe impairment for the patients who present with reduced physical and mental health, lower social status, and poor labour market association (2-4).

In 2005, it was estimated that FSD accounted for 3% of hospitalizations and 10-20% of health care expenses in Denmark (5), and a newer Danish primary care study has shown patients with FSD to have higher annual health care costs compared with conventionally-defined conditions (6). In other countries, studies in clinical samples have shown increased direct and indirect health care costs of FSD (7, 8) showing a dose-response relationship with severity of the FSD (9). These studies into highly selected clinical samples may induce high risk of selection bias, and studies including random selected general population samples are therefore needed. One Canadian population-based study on health care costs of children, adolescents, and young adults with FSD also found increased health care use and costs for this group (10). Studies investigating the socioeconomic burden in terms of welfare benefits of FSD in an adult random sample from the general population are, however, lacking.

Objective To estimate the number of weeks of welfare benefits, i.e. sickness benefit, unemployment benefit and social assistance, for individuals with FSD and compare them to individuals without FSD and individuals with severe physical disease.

Eligibility criteria: Inclusion Criteria:

* None

Exclusion Criteria:

* Not born in Denmark
* Not being a Danish citizen
* Pregnancy

Primary outcomes:
measure: Sickness benefit
timeFrame: 10-year period before and 5-year period after the day the participant participated in the DanFunD baseline investigation
measure: Unemployment benefit
timeFrame: 10-year period before and 5-year period after the day the participant participated in the DanFunD baseline investigation
measure: Social assistance
timeFrame: 10-year period before and 5-year period after the day the participant participated in the DanFunD baseline investigation
Secondary outcomes:
measure: No transfer income/self-support
timeFrame: 10-year period before and 5-year period after the day the participant participated in the DanFunD baseline investigation
measure: Public retirement pension
timeFrame: 10-year period before and 5-year period after the day the participant participated in the DanFunD baseline investigation
measure: Emigration
timeFrame: 10-year period before and 5-year period after the day the participant participated in the DanFunD baseline investigation
measure: Death
timeFrame: 10-year period before and 5-year period after the day the participant participated in the DanFunD baseline investigation
Other outcomes:
Locations:
Study officials:
affiliation: Aarhus University Hospital
name: Per Fink, DMSc
role: STUDY_CHAIR
References: