Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Facilitators and Barriers in Anorexia Nervosa - Treatment Initiation (FABIANA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03713541
Recruitment Status : Enrolling by invitation
First Posted : October 19, 2018
Last Update Posted : October 30, 2018
Sponsor:
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
Prof. Dr. Antje Gumz, Universitätsklinikum Hamburg-Eppendorf

Tracking Information
First Submitted Date August 23, 2018
First Posted Date October 19, 2018
Last Update Posted Date October 30, 2018
Actual Study Start Date May 1, 2018
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 19, 2018)
Duration of untreated illness (DUI in months) [ Time Frame: from date of study enrolment up to 12 weeks ]
DUI (defined as the time between occurence of first symptoms and treatment) is assessed retrospectively and cross-sectional using standardized interviews and paper-and-pencil questionnaires.
Original Primary Outcome Measures
 (submitted: October 17, 2018)
Duration of untreated illness (DUI in months) [ Time Frame: from date of study enrolement up to 12 weeks ]
DUI (defined as the time between occurance of first symptoms and treatment) is assessed retrospectively and cross-sectional using standardized interviews and paper-and-pencil questionnaires.
Change History
Current Secondary Outcome Measures
 (submitted: October 19, 2018)
Duration of first contact (DUC in month) [ Time Frame: from date of study enrolment up to 12 weeks ]
DUC is assessed cross-sectional (retrospectively) using standardized interviews and paper-and-pencil questionnaires.
Original Secondary Outcome Measures
 (submitted: October 17, 2018)
Duration of first contact (DUC in month) [ Time Frame: from date of study enrolement up to 12 weeks ]
DUC is assessed cross-sectional (retrospectively) using standardized interviews and paper-and-pencil questionnaires.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Facilitators and Barriers in Anorexia Nervosa - Treatment Initiation
Official Title Identification of Beneficial and Inhibitory Factors for Treatment in Patients With Anorexia Nervosa: A Pathway to Effective Secondary Prevention and Prognostic Improvement
Brief Summary

Anorexia nervosa (AN) is a comparably low-prevalent illness. Chronic courses are often and the mortality rate of patients with AN is higher than in any other mental illness. A major influence on the course of the illness is the interval between the onset of AN symptoms and the beginning of an adequate treatment (duration of untreated illness, DUI). Patients with AN have a better prognosis if treated early. Previous large-scale interventions have not shown the desired positive effects on the DUI. Therefore, an important starting point seems to be a better initial understanding of the factors influencing the DUI, which is the major aim of this project.

The planned mixed-method study is divided in three consecutive sub-studies. The first substudy aims to identify modifiable factors influencing the DUI using semi-structured interviews and a multi-informant approach (patients, carers, physicians). As a result of this qualitative analyses using Grounded Theory the most relevant factors will be determined. The motivation of the second substudy is to condense the factors identified to influence the DUI into a checklist and to conduct a first psychometric evaluation of this newly developed instrument. The third substudy aims to quantitatively determine the magnitude of the effects of a) a priori determined non-modifiable factors and b) the modifiable checklist-factors using a multi-informant approach (planned n for each informant = 130; 13 co-operating specialized clinics and 6 cooperating outpatient partners). Additional outpatient partners may be recruited during the course of the study.

In conclusion, the study aims to derive recommendations for effective secondary prevention. Thereby, the study might ultimately contribute to earlier treatment initiation of patients with AN, and to the prevention of chronic courses and the associated high health care costs and individual burden.

Detailed Description

Anorexia nervosa (AN) is a comparably low-prevalent, yet due to its somatic and mental consequences serious illness. Chronic courses are often and the mortality rate of patients with AN is higher than in any other mental illness.

A major influence on the course of the illness is the interval between the onset of AN symptoms and the beginning of an adequate treatment (duration of untreated illness, DUI). That is, patients with AN have a better prognosis if treated early. Previous large-scale interventions have not shown the desired positive effects on the DUI. Therefore, an important starting point seems to be a better initial understanding of the factors influencing the DUI, which is the major aim of this project. Based on this evidence, this study aims to derive recommendations for effective secondary prevention.

To our very best knowledge this is the first study investigating factors influencing the DUI using a multi-informant strategy, that is exploring the perspective of patients with AN, their significant carers and involved physicians. Furthermore, the study will avoid the confounding of patients with different eating disorder diagnoses, i.e. it will include exclusively patients with AN. Finally, there will be a clear focus on factors which are modifiable and precise in their definition.

The planned mixed-method study is divided in three consecutive sub-studies. The first substudy aims to identify modifiable factors influencing the DUI using semi-structured interviews and a multi-informant approach (patients, carers, physicians). As a result of this qualitative analyses using Grounded Theory the most relevant factors will be determined. The motivation of the second substudy is to condense the factors identified to influence the DUI into a checklist and to conduct a first psychometric evaluation of this newly developed instrument. The third substudy aims to quantitatively determine the magnitude of the effects of a) a priori determined non-modifiable factors and b) the modifiable checklist-factors using a multi-informant approach (planned n for each informant = 130; 13 co-operating specialized clinics and 6 cooperating outpatient partners). Additional outpatient partners may be recruited during the course of the study.

In conclusion, the study aims to derive recommendations for effective secondary prevention. Thereby, the study might ultimately contribute to earlier treatment initiation of patients with AN, and to the prevention of chronic courses and the associated high health care costs and individual burden.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population

Patients with AN will be recruited from n=13 inpatient clinics with special treatment units/specialized inpatient units and n=6 outpatient psychotherapists specialized for eating disorders.

Additional outpatient partner may be recruited during the course of the study.

Condition
  • Anorexia Nervosa
  • Feeding and Eating Disorders of Childhood
Intervention Other: No intervention
Survey during normal supply.
Study Groups/Cohorts
  • Patients with Anorexia nervosa (AN)
    Female patients with Anorexia nervosa (AN, ICD-10: F50.0/1) of 14 years and older, receiving an initial treatment due to their AN (start of initial treatment no longer than 3 months ago, inpatient care: at least 7 days inpatient; outpatient care: at least 5 sessions with the same therapist) with sufficient language skills and no serious organic or psychiatric illnesses and no acute suicidality will be consecutively included in the study. No intervention.
    Intervention: Other: No intervention
  • Carers of patients with AN
    Significant caregivers in AN patients aged 14 to 15 years: parents; in AN patients aged 16 years and over: parents or other significant carer. No intervention.
    Intervention: Other: No intervention
  • Physicians of patients with AN
    Resident general practitioner, pediatrician, internist or gynecologist with at least one medical patient contact within the last 12 months. No intervention.
    Intervention: Other: No intervention
Publications * Kästner D, Buchholz I, Weigel A, Brunner R, Voderholzer U, Gumz A, Löwe B. Facilitators and barriers in anorexia nervosa treatment initiation (FABIANA): study protocol for a mixed-methods and multicentre study. BJPsych Open. 2019 Oct 21;5(6):e92. doi: 10.1192/bjo.2019.77.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: October 17, 2018)
450
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 2020
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

AN patients

Inclusion criteria

  • Female patients, 14 years and older
  • Treatment diagnosis anorexia nervosa (ICD-10: F50.0/1)
  • Initial treatment (start of initial treatment no longer than 3 months ago)
  • Inpatient care: at least 7 days inpatient
  • Outpatient care: at least 5 sessions with the same therapist

Exclusion criteria

  • Insufficient language skills
  • Serious organic or psychiatric illnesses
  • Acute suicidality

Significant caregiver

Inclusion criteria

  • in AN patients aged 14 to 15 years: parents ; in AN patients aged 16 years and over: parents or other significant carer
  • Informed consent
  • Consent of the patient

Exclusion criteria - Insufficient language skills

Physician

Inclusion criteria

  • Resident general practitioner, pediatrician, internist or gynecologist
  • At least one medical patient contact within the last 12 months
  • Informed consent
  • Consent of the patient and release from confidentiality

Exclusion criteria

- Insufficient language skills

Sex/Gender
Sexes Eligible for Study: Female
Ages 14 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT03713541
Other Study ID Numbers LO 766/16-1m; GU 156
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Prof. Dr. Antje Gumz, Universitätsklinikum Hamburg-Eppendorf
Study Sponsor Universitätsklinikum Hamburg-Eppendorf
Collaborators German Research Foundation
Investigators
Principal Investigator: Antje Gumz, Prof. Dr. Universitätsklinikum Hamburg-Eppendorf
Principal Investigator: Bernd Loewe, Prof. Dr. Universitätsklinikum Hamburg-Eppendorf
PRS Account Universitätsklinikum Hamburg-Eppendorf
Verification Date October 2018