Welfare Benefits in Functional Somatic Disorders

Fibromyalgia Clinical Trial

Official title:

Welfare Benefits for Individuals With Functional Somatic Disorders: DanFunD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05611606
• Other study ID #: DanFunD welfare benefits
• Status: Completed
• Start date: November 10, 2011
• Est. completion date: August 30, 2015

Study information

• Verified date: October 2022
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9656
• Est. completion date: August 30, 2015
• Est. primary completion date: June 30, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• 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
• Fatigue Syndrome, Chronic
• Fibromyalgia
• Irritable Bowel Syndrome
• Medically Unexplained Symptoms
• Somatoform Disorders
• Syndrome

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Center for Clinical Research and Prevention

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sickness benefit	Wellfare benefit disbursed to employed citizens being ill, unemployed citizens currently ill, citizens in activation programs currently ill, and citizens in flexible jobs but currently ill	10-year period before and 5-year period after the day the participant participated in the DanFunD baseline investigation
Primary	Unemployment benefit	Welfare benefit disbursed to unemployed citizens who receive unemployment benefit (full or part time, during vacation or activation) together with citizens on social assistance who are deemed ready-to-work, only receiving social assistance because of unemployment, but having no entitlement to unemployment benefit.	10-year period before and 5-year period after the day the participant participated in the DanFunD baseline investigation
Primary	Social assistance	A welfare payment administered by the municipal social service department and is allocated if citizens are unable to support themselves.	10-year period before and 5-year period after the day the participant participated in the DanFunD baseline investigation
Secondary	No transfer income/self-support	Individuals that do not receive welfare payments under the circumstances of sickness, unemployment, or social benefits. Including leave-of-absence schemes and grants from State Education Fund.	10-year period before and 5-year period after the day the participant participated in the DanFunD baseline investigation
Secondary	Public retirement pension	Public retirement pension	10-year period before and 5-year period after the day the participant participated in the DanFunD baseline investigation
Secondary	Emigration	Participant not resident in Denmark	10-year period before and 5-year period after the day the participant participated in the DanFunD baseline investigation
Secondary	Death	Participant dead	10-year period before and 5-year period after the day the participant participated in the DanFunD baseline investigation