Health Related Quality of Life for Patients With Anorexia Nervosa in Denmark.

NCT03230435 | Active Not Recruiting

• 1 other identifier: QOLAN-DK 10226757
• Study Type: observational
• Target: 496
• Locations: 1 country
• Sites: 1

Brief Summary

Eating disorders (ED) comprise a multitude of symptoms involving a disturbed body image and a preoccupation with food or bodyweight. EDs are often difficult to treat, in part due to the lack of motivation for improvement. Anorexia nervosa (AN) has the highest mortality rate of any psychiatric disease, and less than half of patients will recover from the disease. Studies have found that patients suffering from AN have impaired health-related quality of life (HRQoL) compared to the general population. It has also been suggested that despite improvement in clinical parameters, patients report deterioration in HRQoL, which is in line with a study finding low agreement between patient perceived outcome and clinician assessed characteristics. To evaluate the patients' perception of their disease, it is important to develop reliable and valid assessment tools. Previously generic questionnaires have been used to assess HRQoL in Danish ED patients, as no disease-specific questionnaires have been developed. Translating and validating a disease-specific questionnaire would provide a useful tool in assessing current treatment and in developing new treatment options. This study aimed to develop a Danish version of an internationally disease-specific HRQoL questionnaire. Furthermore, HRQoL is assessed in patients who have gone through shorter or longer treatment.

Conditions

Anorexia Nervosa; Health-Related Quality Of Life

Keywords

anorexia nervosa, health-related quality of life

Outcome Measures

Primary Outcomes (1)

• EDQLS

  Disease specific health related quality of life

  through a hospitalization, an average of 5 weeks

Study Arms (2)

Anorexia nervosa

Treatment settings as usual.

Other: Treatment settings as usual.

Healthy controls

No interventions.

Interventions

Treatment settings as usual. OTHER

Treatment according to guidelines and the local instructions (psychotherapy and dietary guidance).

Anorexia nervosa

Eligibility Criteria

• Age: 13 Years - 40 Years
• Gender Eligibility Details: 90-95% female can be expected among patients with AN. The controls are matched on gender.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

PATIENTS will be recruited through specialized centres in Denmark and through contact to Patient Association's network. CONTROLS will be identified through public call for proposals. The proposals will be posted at institutions of further education and public schools in Odense with students in the appropriate age range.

You may qualify if:

• \. Patients fulfilling Diagnostic and Statistical Manual of Mental Disorders, version 5 (DSM-5) criteria for anorexia nervosa.

You may not qualify if:

• Patients and controls who are unable to complete a Danish language questionnaire.
• Controls: Any medication, except vitamins or oral contraceptives.

Sponsors & Collaborators

• René Klinkby Støving: lead
• Region of Southern Denmark: collaborator
• University of Southern Denmark: collaborator

Study Sites (1)

Department of Endocrinology, Center for Eating Disorders, Odense UH

Odense C, 5000, Denmark

Location

Related Publications (6)

• Winkler LA, Frolich JS, Gudex C, Horder K, Bilenberg N, Stoving RK. Patient- and clinician- reported outcome in eating disorders. Psychiatry Res. 2017 Jan;247:230-235. doi: 10.1016/j.psychres.2016.11.047. Epub 2016 Nov 30.

  PMID: 27923148 BACKGROUND

• Winkler LA, Christiansen E, Lichtenstein MB, Hansen NB, Bilenberg N, Stoving RK. Quality of life in eating disorders: a meta-analysis. Psychiatry Res. 2014 Sep 30;219(1):1-9. doi: 10.1016/j.psychres.2014.05.002. Epub 2014 May 14.

  PMID: 24857566 BACKGROUND

• Winkler LA, Bilenberg N, Horder K, Stoving RK. Does specialization of treatment influence mortality in eating disorders?--A comparison of two retrospective cohorts. Psychiatry Res. 2015 Dec 15;230(2):165-71. doi: 10.1016/j.psychres.2015.08.032. Epub 2015 Aug 28.

  PMID: 26391650 BACKGROUND

• Adair CE, Marcoux GC, Cram BS, Ewashen CJ, Chafe J, Cassin SE, Pinzon J, Gusella JL, Geller J, Scattolon Y, Fergusson P, Styles L, Brown KE. Development and multi-site validation of a new condition-specific quality of life measure for eating disorders. Health Qual Life Outcomes. 2007 Apr 30;5:23. doi: 10.1186/1477-7525-5-23.

  PMID: 17470290 BACKGROUND

• Adair CE, Marcoux GC, Bischoff TF, Cram BS, Ewashen CJ, Pinzon J, Gusella JL, Geller J, Scattolon Y, Fergusson P, Styles L, Brown KE. Responsiveness of the Eating Disorders Quality of Life Scale (EDQLS) in a longitudinal multi-site sample. Health Qual Life Outcomes. 2010 Aug 11;8:83. doi: 10.1186/1477-7525-8-83.

  PMID: 20701776 BACKGROUND

• Winkler LA, Hemmingsen SD, Gudex C, Blegvad AC, Stoving RK, Arnfred SMH. A Danish translation of the eating disorder quality of life scale (EDQLS). J Eat Disord. 2019 May 1;7:11. doi: 10.1186/s40337-019-0241-7. eCollection 2019.

  PMID: 31069077 BACKGROUND

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Officials

• René K Støving, PhD

  Center for Eating Disorders, Odense University Hospital, & Psychiatric survived in Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, PhD

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: July 26, 2017
• Study Start: March 1, 2017
• Primary Completion: February 1, 2024
• Study Completion: January 1, 2025
• Last Updated: February 6, 2024

Record last verified: 2024-02

Locations

DK (1)