Ignite Creation Date:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2026-02-22 @ 9:05 AM
Study NCT ID:
NCT04436861
Status:
WITHDRAWN
Last Update Posted:
2022-06-07
First Post:
2020-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
the Health Crisis at the Healthcare Professionals, Careers and Non-careers, a Month After the Containment Period
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'the sponsor decided to stop the study', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-03', 'studyFirstSubmitDate': '2020-06-11', 'studyFirstSubmitQcDate': '2020-06-17', 'lastUpdatePostDateStruct': {'date': '2022-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Demonstration of the level of anxiety / depression of healthcare professionals and non-healthcare professionals one month after the confinement period', 'timeFrame': '1 month', 'description': 'Anxiety-depression will be assessed by the hospital anxiety and depression scalequestionnaire. The context of life during confinement will be assessed by a self-questionnaire collecting data relating to lifestyle and work.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psychology, Social']}, 'descriptionModule': {'briefSummary': 'The investigator wish to study, at a distance from the lifting of confinement (1 month), whether the psychological impact on professionals in nursing and non-nursing care establishments is associated with their living context (professional and personal situation) during confinement.', 'detailedDescription': 'The context of confinement and of the global pandemic is a major source of stress for the entire population: separation of loved ones, loss of freedom, uncertainty about the infectious status, boredom. All of these factors can cause negative mental health consequences. Having little social contact was one of the factors increasing the negative psychological impact of confinement.\n\nPeople suffering from psychological disorders are particularly vulnerable during quarantine periods. On March 17, 2020, the French government implemented national containment measures due to the Covid-19 epidemic.\n\nAlthough the effects of containment have been studied for fragile populations, no study to date has focused on the specific population of healthcare facility staff. These caregivers have for the most part continued their professional activity, but they have been confronted with the fear of contracting or causing patients to contract Covid-19.\n\nAt a distance from the lifting of confinement (1 month), the investigator wish to study whether the highlighting of anxiety or depression in these healthcare professionals is associated with their context of life (professional and personal situation) during confinement'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We are not basing the study size on statistical arguments for this observational study. The study will be offered to all healthcare professionals in order to limit bias. However, we expect a minimum of 200 responses', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Nursing and non-nursing care professionals\n\nExclusion Criteria:\n\n* Refusal to participate\n* Subject included in an interventional study'}, 'identificationModule': {'nctId': 'NCT04436861', 'briefTitle': 'the Health Crisis at the Healthcare Professionals, Careers and Non-careers, a Month After the Containment Period', 'organization': {'class': 'OTHER', 'fullName': 'Clinique Medipole Garonne'}, 'officialTitle': 'Demonstration of the Level of Anxiety / Depression of Healthcare Professionals and Non-healthcare Professionals One Month After the Confinement Period', 'orgStudyIdInfo': {'id': 'Decovid'}}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinique Medipole Garonne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}