Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2025-12-25 @ 8:22 PM
Study NCT ID:
NCT04304469
Status:
COMPLETED
Last Update Posted:
2022-02-10
First Post:
2020-03-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Management of Women Who Experience Domestic Abuse: Study Comparing Psychological Outcomes at the Maison Des Femmes in Saint-Denis and a Convential Shelter
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-09', 'studyFirstSubmitDate': '2020-03-09', 'studyFirstSubmitQcDate': '2020-03-10', 'lastUpdatePostDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of Post-Traumatic Stress Disorder by PCL-5 Scale', 'timeFrame': 'at the end of study, an average of 6 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Domestic Violence']}, 'referencesModule': {'references': [{'pmid': '38262657', 'type': 'DERIVED', 'citation': 'Roland N, Delmas N, El Khoury F, Bardou A, Yacini L, Feldmann L, Hatem G, Mahdjoub S, Bardou M. Post-traumatic stress disorders in women victims-survivors of intimate partner violence: a mixed-methods pilot study in a French coordinated structure. BMJ Open. 2024 Jan 23;14(1):e075552. doi: 10.1136/bmjopen-2023-075552.'}]}, 'descriptionModule': {'briefSummary': 'ach year, it is estimated that an average of approximately 219,000 women in France suffer physical and/or sexual violence at the hands of their partner or ex-partner. These figures do not take into account other types of violence such as psychological or economic violence. Domestic violence has a major impact on the physical, sexual and psychological health of women victims. For example, the prevalence of post-traumatic stress disorder in these women varies between 33 and 84%, with an average prevalence of 61%, compared with only 2.2% in the French population as a whole. Multidisciplinary medical, social and legal support for these women is essential. In France, there are major territorial disparities in terms of the distribution of facilities for victims of domestoc violence, and not all women victims have the same access to care depending on their place of residence.\n\nThe Maison des Femmes in St Denis has been open since 2016. It offers a unique range of sanitary, social and judicial services through cooperation with police and justice departments, for women who have been subjected to any type of violence.\n\nThis facility is unique in France, and the number of consultations continues to increase, and was more than 8,500 in 2018. The Maison des Femmes model is intended to be exported to other departments, but first the model needs to be validated, beyond its obvious attractiveness (illustrated by the number of consultations and the fact that it attracts women from throughout the Ile de France region) by comparing it to other facilities in terms of its effect on the management of the women.\n\nThis is a cross-sectional prevalence study that estimates the frequency of post-traumatic stress disorder among women who are victims of domestic violence who used the services offered at the Maison des Femmes or other dedicated structures, at the initial consultation and 6 months later.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'women consulting for domestic violence', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female aged 18 and over,\n* Consulted for domestic violence at the Maison des Femmes, St Denis health centre or Aubervilliers health centre.\n* Able to understand the objectives of the study and to respond to the survey\n* Having been informed and not having objected to participating in this study.\n\nExclusion Criteria:\n\n* Unable to understand the objectives of the study and to respond to the surveys.\n* Consulting for another reason.\n* Protected adult under a measure of safeguard.'}, 'identificationModule': {'nctId': 'NCT04304469', 'acronym': 'AVEC-L', 'briefTitle': 'Management of Women Who Experience Domestic Abuse: Study Comparing Psychological Outcomes at the Maison Des Femmes in Saint-Denis and a Convential Shelter', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'Management of Women Who Experience Domestic Abuse: a Feasibility Study Comparing Psychological Outcomes at the Maison Des Femmes in Saint-Denis and a Convential Shelter', 'orgStudyIdInfo': {'id': 'BARDOU THELLIE 2019'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'women', 'description': 'women consulting for domestic violence', 'interventionNames': ['Other: surveys', 'Other: follow-up']}], 'interventions': [{'name': 'surveys', 'type': 'OTHER', 'description': 'delivery of the survey at a domestic violence consultation', 'armGroupLabels': ['women']}, {'name': 'follow-up', 'type': 'OTHER', 'description': 'follow-up of women 6 months after their consultation', 'armGroupLabels': ['women']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21000', 'city': 'Dijon', 'country': 'France', 'facility': 'Chu Dijon Bourgogne', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}