Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-03-01 @ 10:10 AM
Study NCT ID:
NCT04108767
Status:
WITHDRAWN
Last Update Posted:
2023-03-14
First Post:
2019-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Innovative and Transdisciplinary Observation Program for the Quality of Life of Health Students
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011788', 'term': 'Quality of Life'}, {'id': 'D006262', 'term': 'Health'}], 'ancestors': [{'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': "We were not able to conduct this study, in fact we opened the participating center and the confinement arrived a few days later. Since then, the organization of the students' follow-up has changed and made the study as it was thought obsolete.", 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-13', 'studyFirstSubmitDate': '2019-09-26', 'studyFirstSubmitQcDate': '2019-09-27', 'lastUpdatePostDateStruct': {'date': '2023-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Health student's quality of life: WHOQOL BREF questionnaire", 'timeFrame': 'Month 9', 'description': 'The quality of life will be evaluated by the WHOQOL BREF questionnaire (Caria et al, 1995, Baumann et al, 2010) consisting of 26 items exploring physical health (7 items), psychological health (6 items), social relations (3 items), environment (8 items) and the quality of life related to health attesting to the overall satisfaction (2 items). Subject responses are collected using a Likert scale, scored from 1 to 5, summed and converted to a scale of 0 (poor quality of life) to 100 (good quality of life).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Scientific context: Students\' quality of life reflects the general health of students, in connection with the studies themselves, but also with physical, biological, social, cultural, and psychological determinants. Indeed, students are young adults exposed to a complex period composed of transitions in different spheres of their life: housing, domestic tasks, social learning, lifestyle choices, etc. In addition to this, students in medical and health sciences have to face with stress due to a demanding training and exposure to the hospital world. According to the Haute Autorité de Santé (HAS), health professionals in activity or in training are identified as a "population at risk historically identified."\n\nThe studies on stress and psychological disorders, in medical students, are considerably documented on the international level and the incidence of various psychic problems (depressive state, suicidal ideas ...) and behavioural (food behaviours, addictive behaviours ...) has been shown to be predominant in this population. However, no studies have been conducted on aspects like self-esteem, self-efficacy and extracurricular activities. In this sense, it may be interesting to match quality of life of health students in Lyon compared to the results of the other studies carried out in France, and to have a global approach of the factors influencing quality of life, with identification of factors that are potentially harmful, but also beneficial to the global health. This study will also compare the results according to the different health sectors such as medicine, pharmacy, maieutic, odontology, and sciences of rehabilitation.\n\nResearch hypothesis: the study hypothesis is that description of the quality of life and, self-efficacy, self-esteem, nutrition, anxiety, physical activity, sleep quality, and addiction parameters in health student will better characterize student\'s issues in order to propose an appropriate intervention to improve their global health.\n\nThe study is an observational, cross sectional and monocentric study conducted among the population of students of the Lyon 1 University in the health science field on a 9 months period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study target the exhaustivity of the eligible population since all students are concerned by the mandatory visit.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (\\> 18 years)\n* Enrolled in 3rd year of health study (Medicine, pharmacy, Institute of Rehabilitation Sciences and Techniques, odontology, maieutic) at the UCBL\n* Participation at the required medical consultation at the college Health Department of UCBL\n\nExclusion Criteria:\n\n* Lack of comprehension of the French language\n* Implementation of protective measures\n* Erasmus program'}, 'identificationModule': {'nctId': 'NCT04108767', 'acronym': 'POSITIVE', 'briefTitle': 'Innovative and Transdisciplinary Observation Program for the Quality of Life of Health Students', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Innovative and Transdisciplinary Observation Program for the Quality of Life of Health Students', 'orgStudyIdInfo': {'id': '69HCL19_0398'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Health students enrolled in the 3rd year at the University Cla', 'description': 'Health students enrolled in the 3rd year at the University Claude Bernard Lyon 1, aged over 18 years.', 'interventionNames': ['Behavioral: Answer to standardized questionnaires in quality of life, health, lifestyle and behaviors']}], 'interventions': [{'name': 'Answer to standardized questionnaires in quality of life, health, lifestyle and behaviors', 'type': 'BEHAVIORAL', 'description': 'The cross-sectional study will be conducted in all students in health sciences in 3rd year enrolled at the University Claude Bernard Lyon 1 (UCBL) and participating at the required medical consultation at the college Health Department of UCBL, over a period of 9 months.\n\nThe self-questionnaires will be completed by the students during the mandatory medical preventive visit at the university health center.\n\nAll dimensions investigated by the questionnaire are usually questioned by the caregivers during the consultation as part of the usual follow-up of students.', 'armGroupLabels': ['Health students enrolled in the 3rd year at the University Cla']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lyon', 'country': 'France', 'facility': 'University Health Department Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'Julie Haesebaert, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospices Civils de Lyon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}