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Health Related Quality of Life for Patients With Anorexia Nervosa in Denmark. (QOLAN-DK)

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ClinicalTrials.gov Identifier: NCT03230435
Recruitment Status : Recruiting
First Posted : July 26, 2017
Last Update Posted : July 26, 2017
Sponsor:
Collaborators:
Psychiatric Services in the Region of Southern Denmark
University of Southern Denmark
Information provided by (Responsible Party):
René Klinkby Støving, Odense University Hospital

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.

Condition or disease Intervention/treatment
Anorexia Nervosa Health-Related Quality Of Life Other: Treatment settings as usual.

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 496 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Health Related Quality of Life for Patients With Anorexia Nervosa in Denmark.
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : May 31, 2018
Estimated Study Completion Date : March 31, 2019

Group/Cohort Intervention/treatment
Anorexia nervosa
Treatment settings as usual.
Other: Treatment settings as usual.
Treatment according to guidelines and the local instructions (psychotherapy and dietary guidance).

Healthy controls
No interventions.



Primary Outcome Measures :
  1. EDQLS [ Time Frame: through a hospitalization, an average of 5 weeks ]
    Disease specific health related quality of life



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Ages Eligible for Study:   13 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   90-95% female can be expected among patients with AN. The controls are matched on gender.
Accepts Healthy Volunteers:   Yes
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.

Criteria

INCLUSION CRITERIA

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

EXCLUSION CRITERIA

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03230435


Contacts
Contact: Laura AD Winkler, PhD 65415307 ext +45 laura.vad.winkler@rsyd.dk
Contact: René K Støving, PhD 65411710 ext +45 rene.k.stoving@gmail.com

Locations
Denmark
Department of Endocrinology, Center for Eating Disorders, Odense UH Recruiting
Odense C, Denmark, 5000
Contact: Laura AD Winkler, PhD       laura.vad.winkler@rsyd.dk   
Contact: René K Støving, PhD    65411710 ext +45    rene.stoeving@rsyd.dk   
Sponsors and Collaborators
René Klinkby Støving
Psychiatric Services in the Region of Southern Denmark
University of Southern Denmark
Investigators
Principal Investigator: René K Støving, PhD Center for Eating Disorders, Odense University Hospital, & Psychiatric survived in Southern Denmark

Publications:
Responsible Party: René Klinkby Støving, Professor, PhD, Odense University Hospital
ClinicalTrials.gov Identifier: NCT03230435     History of Changes
Other Study ID Numbers: QOLAN-DK 10226757
First Posted: July 26, 2017    Key Record Dates
Last Update Posted: July 26, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data will be stored at Odense patient Data Explorative Network (OPEN).

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by René Klinkby Støving, Odense University Hospital:
anorexia nervosa, health-related quality of life

Additional relevant MeSH terms:
Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders