- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03230435
Health Related Quality of Life for Patients With Anorexia Nervosa in Denmark. (QOLAN-DK)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
INTRODUCTION Anorexia nervosa (AN) is an eating disorder of unknown etiology. The evidence base for treatment is still very limited considering the extent to which this disorder erodes lives and still carries the highest fatality rate of any psychiatric disease as well as any other chronic disease in adolescence.
There is no consensus on appropriate effect goals in AN. Assessment of biomedical parameters alone is not sufficient, why evaluation tools that consider the patient's own perception of their health and well-being are essential. However, patients with AN characteristically have a different opinion of their needs to that of the health professionals, which can lead to differences in treatment goals, ambivalence towards treatment, and immense compliance difficulties.
Health-related quality of life (HRQOL) can be defined as the overall effect of a medical condition and/or its consequent therapy upon a patient. HRQOL is subjective and multidimensional, encompassing physical and occupational function, psychological state, social interaction and somatic sensation. Discrepancy between one's current level of function and one's ideals or expectations can result in lower self-rated HRQOL, while cognitive flexibility is believed to contribute to good HRQOL. Patients with AN typically have unrealistically high expectations of themselves, are often rigid and usually do not consider weight gain to be a necessity for a positive outcome. Therefore, treatment may potentially lead to further reduction of HRQOL (for example due to coerced hospitalization), despite significant positive improvements in biomedical parameters.
In a recently published meta-analysis examining the HRQOL of patients with eating disorders, several methodological challenges were identified such as variations in study design, diagnostic criteria and health outcome measurement. It is essential that HRQOL measures are valid and reliable for the patient group in question. These measures can be either generic (applicable to all patient groups) or disease-specific (designed to detect HRQOL changes specific to a disease).
Only a few disease-specific HRQOL measures for AN have been developed. The Eating Disorder Quality of Life (EDQLS) questionnaire was published by a Canadian research group and consists of 40 items on selected topics including relationships with family and others, physical and psychological health and eating. Subsequent studies have shown that the EDQLS demonstrates excellent psychometric properties in terms of validity, reliability and responsiveness to change.
OBJECTIVES
- To validate a Danish version of the Eating Disorder Quality of Life questionnaire in two age ranges, 13-17 years and +18 years in patients with AN.
- To assess age-specific HRQoL in patients with AN in different treatment settings.
DESIGN Preparatory study: Testing and adaptation of the Danish version of the EDQLS for use by 13-17 year olds with anorexia nervosa.
Study 1: Concurrent validity and internal consistency. EDQLS, ED symptomatology, distress, social function and generic HRQOL assessed in different clinical samples of AN patients aged 13-17 & +18 years and in a sample of age-matched healthy controls within a normal weight range.
Study 2: Test-retest reliability. EDQLS completed twice with a 2-4-week interval in a sample of weight- and treatment-stable outpatients and controls aged 13-17 & +18 years.
Study 3: Sensitivity to change. EDQLS applied three times over a 4-6-week interval in a sample of AN inpatients aged 13-17 & +18 years.
Study 4: Patients outside the established treatment. EDQLS, ED symptomatology, distress, social function and generic HRQoL score among members and followers with BMI<18 recruited from the official website for the national patient organizations.
METHODS
TRANSLATION Prior to this study, the initial translations of the EDQLS was carried out using the method recommended by WHO World Mental Health Initiative Translation Guidelines. After permission from the Canadian authors, an expert panel of bilingual staff from an ED outpatient clinic worked on the translation from English to Danish, aiming for conceptual equivalence between the versions (i.e. similar relevance and meaning in the two languages/cultures). After panel discussions to create a consensus version the Danish draft questionnaire was completed individually by 18 adult women with AN, who in subsequent qualitative interviews commented on their understanding of the items and any difficulties they had with the wording. The linguistic comments and suggestions from the patients were used to further improve the translation, which was then approved by the expert panel. This draft was back-translated and the back-translation was reviewed by the Canadian authors of the scale. After the refinement of a single word, it was accepted as the official Danish EDQLS translation. Both the Danish version and the original EDQLS are licensed.
In the present study, the original EDQLS will be tested and adjusted as necessary for use patients aged 13-17 years. This will be done by repeating the qualitative interviews with six adolescents AN patients (13-17 years) to investigate whether the questionnaire should be linguistically modified for this age group. Any modifications will be discussed with the Canadian developers of EDQLS.
MEASURES Screening questionnaire: Patients will be asked to fill out a questionnaire regarding current weight, height and information regarding current medication.
Disease-specific quality of life (EDQLS). WHO-5 Well-being Index (WHO-5). Generic health related quality of life: Short Form-36 (SF-36). Eating disorder symptomatology: Eating Disorder Inventory-3. Depression: The Beck Depression Inventory II (BDI-II). Impairment in functioning: Work and Social Adjustment Scale (WSAS). Total item burden: Total amount of measures is 201 items. Estimated time for administration is about two hours. The questionnaires are stored in RedCap, automatically uploading the answers as the patients fill them out.
DATA ANALYSES AND STATISTICS
POWER CALCULATIONS The sample size is based on the validation work of the original language version in Canada. A high response rate of at least 80% is expected because there is a high participatory interest in the subject and purpose of the study, and because the participants receive a small fee.
MULTIVARIATE ANALYSES Description of the subsamples is presented as means and standard deviations and frequencies. Inter-item correlations and confirmatory factor analyses are performed on the full sample across age-groups and health status and in sub-populations. Pearson correlations are produced for the included symptom and HRQOL scores.
ETHICAL CONSIDERATIONS According to Danish legislation, surveys are exempt from ethical board review. However, a formal enquiry was made and the ethical board determined that the project was approved without further application to the ethical committee. Participants will be informed that study participation is voluntary, and will have no effect on their treatment and management. There are no risks associated with participating in the study.
All questionnaires and tests used in the study are validated, recommended and widely distributed clinically for diagnosing in psychiatry.
To facilitate a high proportion of completion, all participants (patients and controls) who complete the test are honored with Danish kroner (DDK) 150.
ANONYMITY The project is approved by the Data Protection Agency, File no. 17/3218. The data will be stored in a data sheet, REDCap.
FINANCE The study is a 100 % non-commercial study. The Jascha Fund has supported the post doc salary for 18 months. There will be applied for licenses, participation fees, and operating expenses.
DISSEMINATION AND TENTATIVE PUBLICATIONS
The study findings, both positive and negative results, will be disseminated through communication at congresses and written scientific publications. Publications will be made according to the Vancouver criteria with the tentative titles:
- Health-related quality of life in anorexia nervosa: Validation of a Danish language version in young and adult patients.
- In-patients treatment of anorexia nervosa: Does it improve health related quality of life?
- Patients with anorexia nervosa, not seeking established treatment: specific health related quality of life.
- Gender differences in health-related quality of life in patients with anorexia nervosa.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Laura AD Winkler, PhD
- Phone Number: +45 65415307
- Email: laura.vad.winkler@rsyd.dk
Study Contact Backup
- Name: René K Støving, PhD
- Phone Number: +45 65411710
- Email: rene.k.stoving@gmail.com
Study Locations
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Odense C, Denmark, 5000
- Department of Endocrinology, Center for Eating Disorders, Odense UH
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
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.
Description
INCLUSION CRITERIA
1. Patients fulfilling Diagnostic and Statistical Manual of Mental Disorders, version 5 (DSM-5) criteria for anorexia nervosa.
EXCLUSION CRITERIA
- Patients and controls who are unable to complete a Danish language questionnaire.
- Controls: Any medication, except vitamins or oral contraceptives.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Anorexia nervosa
Treatment settings as usual.
|
Treatment according to guidelines and the local instructions (psychotherapy and dietary guidance).
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Healthy controls
No interventions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
EDQLS
Time Frame: through a hospitalization, an average of 5 weeks
|
Disease specific health related quality of life
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through a hospitalization, an average of 5 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: René K Støving, PhD, Center for Eating Disorders, Odense University Hospital, & Psychiatric survived in Southern Denmark
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- QOLAN-DK 10226757
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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