Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT04635358
Status:
COMPLETED
Last Update Posted:
2024-02-06
First Post:
2020-11-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility Study of Smoking Cessation for the Staff of a Hospital Center
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006990', 'term': 'Hypnosis'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2021-10-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-05', 'studyFirstSubmitDate': '2020-11-13', 'studyFirstSubmitQcDate': '2020-11-13', 'lastUpdatePostDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of subjects enrolled in the program who participated in the full range of care offered', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Smoking, hypnosis, nutrition support, psychological support'], 'conditions': ['Smoking Cessation']}, 'descriptionModule': {'briefSummary': 'The recorded prevalence of daily smoking among health professionals (doctors, nurses, midwives, etc.), regardless of their mode of practice (salaried or self-employed, etc.) varies between 14 and 23%. In health care institutions, according to the studies, the prevalence of daily smoking among staff, caregivers and non-caregivers ranges from 17% to 27%. These professionals who continue to smoke, although they are particularly well informed about the risks they run, probably constitute a group with specific withdrawal difficulties. Beyond the impact on their own health, the smoking status of caregivers could also have an impact on the management of tobacco patients. There are very few studies of the impact of interventions on the smoking status of caregivers in health care facilities. The combination of several intervention modalities can facilitate the participation of target professionals and generate efficiency synergies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nProfessionals employed at the Nice hospital who are volunteers and have :\n\n* an initial Fagerstrom test \\> 3\n* associated with expired carbone monoxide \\> 10 ppm at least 60' after the last cigarette.\n\nExclusion Criteria:\n\n* Reported associated addiction (cannabis, alcohol or any other psychoactive product)\n* Professionals likely to no longer work at the Nice Hospital in the year following the start of the study\n* Pregnant or breastfeeding woman"}, 'identificationModule': {'nctId': 'NCT04635358', 'acronym': 'Je_Respire', 'briefTitle': 'Feasibility Study of Smoking Cessation for the Staff of a Hospital Center', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Feasibility Study of Smoking Cessation for the Staff of a Hospital Center Through a Treatment Proposal Combining Nicotine Substitutes, Psychological Support, Nutritional Assistance and Hypnosis.', 'orgStudyIdInfo': {'id': '19-PP-16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Setting up hypnosis sessions, psychological and nutritional assistance.', 'interventionNames': ['Behavioral: Hypnosis', 'Behavioral: Psychological support', 'Behavioral: Nutrional support']}], 'interventions': [{'name': 'Hypnosis', 'type': 'BEHAVIORAL', 'description': 'Setting up hypnosis sessions', 'armGroupLabels': ['Intervention']}, {'name': 'Psychological support', 'type': 'BEHAVIORAL', 'description': 'Setting up psychological support', 'armGroupLabels': ['Intervention']}, {'name': 'Nutrional support', 'type': 'BEHAVIORAL', 'description': 'Setting up nutritional support', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06003', 'city': 'Nice', 'country': 'France', 'facility': 'CHU de Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'overallOfficials': [{'name': 'Bernard PROUVOST-KELLER, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Nice'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}