Evaluation of Hospitalization for Anorexia Nervosa (EVALuation de l'Apport de l'HOSPITalisation Pour Anorexie Mentale : EVALHOSPITAM) (EVHAN)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Institut Mutualiste Montsouris.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Institut Mutualiste Montsouris
Collaborators:
Institut National de la Santé Et de la Recherche Médicale, France
Ministry of Health, France
Agence Nationale de la Recherche
Caisse nationale d'assurance maladie
Fondation de la Mutuelle Générale de l'Education Nationale
Fondation de France
Information provided by:
Institut Mutualiste Montsouris
ClinicalTrials.gov Identifier:
NCT00910169
First received: May 26, 2009
Last updated: August 6, 2012
Last verified: May 2009
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The objective of this research is to evaluate the efficacy of five different in-patient treatment modalities and predictive factors of outcome for anorexia nervosa. The primary hypothesis is that the different treatment types impact outcome of patients at discharge from inpatient treatment and at one year follow-up, even after adjustment for confounding factors (age, length of illness, number of previous hospitalizations, clinical state at intake).
| Condition | Intervention |
|---|---|
|
Anorexia Nervosa |
Other: inpatient treatment |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Evaluation of Hospitalization for Anorexia Nervosa: Efficacy of Treatment and Predictive Factors of Outcome. |
Further study details as provided by Institut Mutualiste Montsouris:
Primary Outcome Measures:
- Morgan and Russell score [ Time Frame: one year follow-up ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Nutritional status [ Time Frame: one year follow-up ] [ Designated as safety issue: No ]
- Eating disorders symptoms and diagnosis [ Time Frame: one year follow-up ] [ Designated as safety issue: No ]
- Psychiatric symptoms and disorders [ Time Frame: one year follow-up ] [ Designated as safety issue: No ]
- Cognitive functioning [ Time Frame: one year follow-up ] [ Designated as safety issue: No ]
- Somatic symptoms and complications [ Time Frame: one year follow-up ] [ Designated as safety issue: No ]
- Social adjustment [ Time Frame: one year follow-up ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: one year follow-up ] [ Designated as safety issue: No ]
- Family relationships [ Time Frame: one year follow-up ] [ Designated as safety issue: No ]
- Re-hospitalization [ Time Frame: one year follow-up ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
all biological analysis during hospitalisation, serotonin , tryptophan, CD4/CD8
| Estimated Enrollment: | 300 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
inpatient treatment
naturalistic treatment no modification: observational study
|
Other: inpatient treatment
Hospitalisation modalities are described but are naturalistic
Other Name: naturalistic treatment
|
Detailed Description:
This study will evaluate global, psychiatric, somatic and psychosocial outcome for inpatients with anorexia nervosa through three evaluations (intake, discharge and one-year follow-up). The study will also consider five types of in-patient treatment in a naturalistic setting (i.e., patients will not be assigned to different treatment conditions; rather, we will study inpatient care as it exists today). The five treatment modalities to be studied are:
- Discharge weight objectives.
- The practice of a separation period.
- The use of clear nutritional and dietary objectives (cognitive/behavioural).
- The intensity of family involvement in treatment.
- Stabilisation phase before ending inpatient treatment.
Eligibility| Ages Eligible for Study: | 8 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
All patients hospitalisied in 11 tertiary centers for eating disorders in france
Criteria
Inclusion Criteria:
- All patients who accept participation between 8 and 50 years old, consecutively hospitalized for a DSM IV diagnosis of Anorexia Nervosa in one of the departments participating in this research by necessity of physical condition (BMI < 15, rapid weight loss) or psychological condition
- Parents of participating patients still living with their parents who accept participation
Exclusion Criteria:
- Refusal of research
- Patients who do not speak French
- Patients with a related somatic illness (diabetes, Crohn's disease, metabolic illness)
- Patients not covered by social security health insurance
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00910169
Locations
| France | |
| Insitut Mutualiste Montsouris | |
| Paris, France, 75014 | |
Sponsors and Collaborators
Institut Mutualiste Montsouris
Institut National de la Santé Et de la Recherche Médicale, France
Ministry of Health, France
Agence Nationale de la Recherche
Caisse nationale d'assurance maladie
Fondation de la Mutuelle Générale de l'Education Nationale
Fondation de France
Investigators
| Principal Investigator: | Godart Nathalie, PhD | INSERM and Institut Mutualiste Montsouris |
More Information
No publications provided
| Responsible Party: | Nathalie Godart, M.D., Ph.D., Institut Mutualiste Montsouris |
| ClinicalTrials.gov Identifier: | NCT00910169 History of Changes |
| Other Study ID Numbers: | Eudract: 2007 -A01110-53, ANR-0-JC0719-6328, PHRC AOM 06 020 |
| Study First Received: | May 26, 2009 |
| Last Updated: | August 6, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: Direction Générale de la Santé France: Institutional Ethical Committee |
Keywords provided by Institut Mutualiste Montsouris:
|
Anorexia nervosa treatment inpatient efficacy outcome |
Additional relevant MeSH terms:
|
Anorexia Anorexia Nervosa Signs and Symptoms, Digestive |
Signs and Symptoms Eating Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 21, 2013