Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-31 @ 9:22 PM
Study NCT ID:
NCT04387708
Status:
COMPLETED
Last Update Posted:
2021-12-20
First Post:
2020-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Care in Patients Hospitalized for Anorexia Nervosa at the Time of the Coronavirus-19 Epidemic (QUALICOVID)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000856', 'term': 'Anorexia Nervosa'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'FAMILY_BASED'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-17', 'studyFirstSubmitDate': '2020-05-13', 'studyFirstSubmitQcDate': '2020-05-13', 'lastUpdatePostDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Content analysis concerning the reorganization of care for children or adolescent and thier parents', 'timeFrame': '1 interview for each participant during 45 minutes', 'description': 'Analyzing the discourse content regarding the experiences related to changes in the care of patients with anorexia nervosa hospitalized in a child and adolescent psychiatric ward in Nancy, France, and their parents, in the context of the Covid-19 crisis.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anorexia nervosa', 'child psychiatry', 'covid-19', 'qualitative study'], 'conditions': ['Anorexia Nervosa']}, 'descriptionModule': {'briefSummary': 'Anorexia nervosa is a severe psychiatric condition. On the nutritional level, one of the objectives recommended by the High Authority of Health is to "achieve and maintain an appropriate weight and nutritional status". It is recommended that, in the event of hospitalisation, this should be "as long as necessary" and be based on a weight contract as a condition for discharge. Within the Pôle Universitaire de Psychiatrie de l\'Enfant et de l\'Adolescent of the Centre Psychothérapique de Nancy, an inpatient unit takes care of children and adolescents with a specific valence in the management of patients suffering from eating disorders.\n\nSince the first quarter of 2020, France has been progressively affected by the pandemic of the coronavirus 2019, Covid-19. This pandemic has led to unprecedented containment measures in France and around the world.\n\nAt the time of the announcement of the implementation of containment, the investigators proposed to the parents of patients hospitalized in the Child and Adolescent Psychiatry Department of the Nancy Psychotherapy Center who were approaching their discharge weight to be able to end their hospitalization prematurely. As a follow-up to this hospitalisation, intensive outpatient care was offered to the families, in accordance with State recommendations in connection with the pandemic. In this hospitalized unit, weekly outpatient consultations were maintained and coupled with telephone interviews, teleconsultation interviews and a telephone hotline for the healthcare team.\n\nThe objective of the study is to explore, in a qualitative way, the experiences of patients hospitalized in the child psychiatry department for anorexia nervosa at the time of the coronavirus epidemic in France and those of their parents, in relation to the reorganization of care.', 'detailedDescription': "Interviews will be recorded, made anonymous and transcribed verbatim. The resulting text will be subjected to an inductive thematic analysis. The investigators will analyse the interviews to identify themes. Then, based on the preliminary results, higher key themes will be proposed, i.e. the themes most present and salient in the material. They will look for a concordance between the different members of each family. Several profiles may be proposed based on the patient's and parents' experiences and will be presented in the form of a thematic tree.\n\nThe study will be proposed to all eligible patients in order to obtain as much material as possible."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The source population represents six patients, aged 9 to 17 years in March 2020 and their parents.\n\nFour of the six patients went home on the day the lockdown measures were announced, one patient went home three days later so that her parents would be available, and one patient remained in hospital because of a physical condition incompatible with a return home.\n\nThe population is therefore made up of 18 people: patients (6) and their parents (12).\n\nIt will be possible to interview the parent(s) without interviewing the child if the child refuses to participate in the study.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Criteria for inclusion :\n\n 1/ For patients :\n* To have been hospitalized in the child and adolescent psychiatry unit of the Pôle Universitaire de Psychiatrie de l'Enfant et de l'Adolescent du Centre Psychothérapique de Nancy on 16 March 2020\n* With a diagnosis of anorexia nervosa (ICD-10 F500)\n* Understand and speak French fluently\n* Have been informed of the study, have received the study briefing note and have not objected to participating in the study.\n* That the holders of parental authority have been informed of the study, have received the information note on the study and have not objected to their child's participation\n* Be affiliated to or entitled to a social security scheme\n\n 2/ For the parents :\n* To have a child who meets the inclusion criteria mentioned above.\n* Understand and speak French fluently\n* Have been informed of the study, have received the study briefing note and have not objected to participating in the study.\n\nExclusion Criteria:\n\n* no"}, 'identificationModule': {'nctId': 'NCT04387708', 'acronym': 'QUALICOVID', 'briefTitle': 'Care in Patients Hospitalized for Anorexia Nervosa at the Time of the Coronavirus-19 Epidemic (QUALICOVID)', 'organization': {'class': 'OTHER', 'fullName': 'Centre Psychothérapique de Nancy'}, 'officialTitle': 'Reorganization of Care in Patients Hospitalized in Child Psychiatry for Anorexia Nervosa at the Time of the Coronavirus-19 Epidemic in France: Qualitative Study Carried Out on Patients and Their Parents', 'orgStudyIdInfo': {'id': 'RIPH 2020-01'}, 'secondaryIdInfos': [{'id': 'IDRCB 2020-A01101-38', 'type': 'OTHER', 'domain': 'ANSM (French competent authority)'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Laxou', 'country': 'France', 'facility': 'Centre Psychothérapique de Nancy', 'geoPoint': {'lat': 48.68372, 'lon': 6.14929}}], 'overallOfficials': [{'name': 'Marilou Lamourette, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Psychothérapique de Nancy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Psychothérapique de Nancy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}