Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-28 @ 10:44 PM
Study NCT ID:
NCT00910169
Status:
UNKNOWN
Last Update Posted:
2012-08-07
First Post:
2009-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Hospitalization for Anorexia Nervosa (EVALuation de l'Apport de l'HOSPITalisation Pour Anorexie Mentale : EVALHOSPITAM)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000856', 'term': 'Anorexia Nervosa'}], 'ancestors': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006760', 'term': 'Hospitalization'}], 'ancestors': [{'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'all biological analysis during hospitalisation, serotonin , tryptophan, CD4/CD8'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'completionDateStruct': {'date': '2012-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-08-06', 'studyFirstSubmitDate': '2009-05-26', 'studyFirstSubmitQcDate': '2009-05-28', 'lastUpdatePostDateStruct': {'date': '2012-08-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morgan and Russell score', 'timeFrame': 'one year follow-up'}], 'secondaryOutcomes': [{'measure': 'Nutritional status', 'timeFrame': 'one year follow-up'}, {'measure': 'Eating disorders symptoms and diagnosis', 'timeFrame': 'one year follow-up'}, {'measure': 'Psychiatric symptoms and disorders', 'timeFrame': 'one year follow-up'}, {'measure': 'Cognitive functioning', 'timeFrame': 'one year follow-up'}, {'measure': 'Somatic symptoms and complications', 'timeFrame': 'one year follow-up'}, {'measure': 'Social adjustment', 'timeFrame': 'one year follow-up'}, {'measure': 'Quality of life', 'timeFrame': 'one year follow-up'}, {'measure': 'Family relationships', 'timeFrame': 'one year follow-up'}, {'measure': 'Re-hospitalization', 'timeFrame': 'one year follow-up'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Anorexia nervosa', 'treatment', 'inpatient', 'efficacy', 'outcome'], 'conditions': ['Anorexia Nervosa']}, 'referencesModule': {'references': [{'pmid': '36807834', 'type': 'DERIVED', 'citation': 'Duclos J, Piva G, Riquin E, Lalanne C, Meilleur D, Blondin S; EVHAN Group; Cook-Darzens S, Godart N. Caregivers in anorexia nervosa: is grief underlying parental burden? Eat Weight Disord. 2023 Feb 20;28(1):16. doi: 10.1007/s40519-023-01530-x.'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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:\n\n1. Discharge weight objectives.\n2. The practice of a separation period.\n3. The use of clear nutritional and dietary objectives (cognitive/behavioural).\n4. The intensity of family involvement in treatment.\n5. Stabilisation phase before ending inpatient treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '8 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients hospitalisied in 11 tertiary centers for eating disorders in france', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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\n* Parents of participating patients still living with their parents who accept participation\n\nExclusion Criteria:\n\n* Refusal of research\n* Patients who do not speak French\n* Patients with a related somatic illness (diabetes, Crohn's disease, metabolic illness)\n* Patients not covered by social security health insurance"}, 'identificationModule': {'nctId': 'NCT00910169', 'acronym': 'EVHAN', 'briefTitle': "Evaluation of Hospitalization for Anorexia Nervosa (EVALuation de l'Apport de l'HOSPITalisation Pour Anorexie Mentale : EVALHOSPITAM)", 'organization': {'class': 'OTHER', 'fullName': 'Institut Mutualiste Montsouris'}, 'officialTitle': 'Evaluation of Hospitalization for Anorexia Nervosa: Efficacy of Treatment and Predictive Factors of Outcome.', 'orgStudyIdInfo': {'id': 'Eudract: 2007 -A01110-53'}, 'secondaryIdInfos': [{'id': 'ANR-0-JC0719-6328'}, {'id': 'PHRC AOM 06 020'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'inpatient treatment', 'description': 'naturalistic treatment no modification: observational study', 'interventionNames': ['Other: inpatient treatment']}], 'interventions': [{'name': 'inpatient treatment', 'type': 'OTHER', 'otherNames': ['naturalistic treatment'], 'description': 'Hospitalisation modalities are described but are naturalistic', 'armGroupLabels': ['inpatient treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Insitut Mutualiste Montsouris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Godart Nathalie, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'INSERM and Institut Mutualiste Montsouris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Mutualiste Montsouris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}, {'name': 'Ministry of Health, France', 'class': 'OTHER_GOV'}, {'name': 'National Research Agency, France', 'class': 'OTHER'}, {'name': 'National Health Insurance Fund', 'class': 'OTHER'}, {'name': "Fondation de la Mutuelle Générale de l'Education Nationale", 'class': 'UNKNOWN'}, {'name': 'Fondation de France', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Nathalie Godart, M.D., Ph.D.', 'oldOrganization': 'Institut Mutualiste Montsouris'}}}}