Welfare Benefits in Functional Somatic Disorders

Sponsor
University of Aarhus (Other)
Overall Status
Completed
CT.gov ID
NCT05611606
Collaborator
Center for Clinical Research and Prevention (Other)
9,656
45.6

Study Details

Study Description

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.

Study Design

Study Type:
Observational
Actual Enrollment :
9656 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Welfare Benefits for Individuals With Functional Somatic Disorders: DanFunD
Actual Study Start Date :
Nov 10, 2011
Actual Primary Completion Date :
Jun 30, 2015
Actual Study Completion Date :
Aug 30, 2015

Arms and Interventions

Arm Intervention/Treatment
DanFunD baseline

Data from the DanFunD baseline cohort will be included (11). 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) (2) and diagnostic research interviews (n=1,590) (12). 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 (14) and diagnostic interviews (3) Three functional somatic syndromes, i.e. irritable bowel (15), chronic widespread pain (16), and chronic fatigue (17) will be defined with questionnaires. Severe physical disease will be defined as having received at least one of the following five diagnoses: Cancer, stroke, myocardial infarction, other heart disease, and obstructive pulmonary disease.

Outcome Measures

Primary Outcome Measures

  1. Sickness benefit [10-year period before and 5-year period after the day the participant participated in the DanFunD baseline investigation]

    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

  2. Unemployment benefit [10-year period before and 5-year period after the day the participant participated in the DanFunD baseline investigation]

    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.

  3. Social assistance [10-year period before and 5-year period after the day the participant participated in the DanFunD baseline investigation]

    A welfare payment administered by the municipal social service department and is allocated if citizens are unable to support themselves.

Secondary Outcome Measures

  1. No transfer income/self-support [10-year period before and 5-year period after the day the participant participated in the DanFunD baseline investigation]

    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.

  2. Public retirement pension [10-year period before and 5-year period after the day the participant participated in the DanFunD baseline investigation]

    Public retirement pension

  3. Emigration [10-year period before and 5-year period after the day the participant participated in the DanFunD baseline investigation]

    Participant not resident in Denmark

  4. Death [10-year period before and 5-year period after the day the participant participated in the DanFunD baseline investigation]

    Participant dead

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 76 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • None
Exclusion Criteria:
  • Not born in Denmark

  • Not being a Danish citizen

  • Pregnancy

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Aarhus
  • Center for Clinical Research and Prevention

Investigators

  • Study Chair: Per Fink, DMSc, Aarhus University Hospital

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT05611606
Other Study ID Numbers:
  • DanFunD welfare benefits
First Posted:
Nov 10, 2022
Last Update Posted:
Dec 5, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 5, 2022