Ignite Creation Date:
2025-12-24 @ 10:12 PM
Ignite Modification Date:
2026-01-07 @ 7:01 AM
Study NCT ID:
NCT05974735
Status:
UNKNOWN
Last Update Posted:
2023-10-13
First Post:
2023-07-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adaptability to Stress of Healthcare Workers in the 8th Arrondissement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073397', 'term': 'Occupational Stress'}], 'ancestors': [{'id': 'D009784', 'term': 'Occupational Diseases'}, {'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-12', 'studyFirstSubmitDate': '2023-07-12', 'studyFirstSubmitQcDate': '2023-07-26', 'lastUpdatePostDateStruct': {'date': '2023-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the 3-month effectiveness of a well-being programme in improving stress management among healthcare professionals and workers with moderate stress.', 'timeFrame': '3 Months', 'description': 'Changes in the Perceived Stress Scale (PSS) score at 3 months after the SMS setting up the wellness pathway. The PSS is a score based on the sum of the values assigned to each response of 10 different items. The minimum score is 0 and the maximum score is 50. The higher the score, the more stressed the respondent is.'}], 'secondaryOutcomes': [{'measure': 'Evaluate the effectiveness of a well-being programme in improving stress management in healthcare professionals and workers with moderate stress at 6 months', 'timeFrame': '6 Months', 'description': 'Change in the Perceived Stress Scale (PSS) at 6 months from the SMS used to set up the wellness pathway. The PSS is a score based on the sum of the values assigned to each response of 10 different items. The minimum score is 0 and the maximum score is 50. The higher the score, the more stressed the respondent is.'}, {'measure': 'Evaluate the effectiveness of a well-being programme in improving the lifestyle habits of healthcare professionals and workers at 3 and 6 months', 'timeFrame': '3 and 6 Months', 'description': 'Evolution of the score obtained in the Lifestyle Questionnaire at 3 and 6 months after the SMS for the implementation of the wellness pathway. The Lifestyle Questionnaireis a score based on the assignment of a score for 4 health risk domains: Stress, Diet, Physical Activity and Sleep. The minimum score is 0 and the maximum score is 100 for each of the 4 items. The lower the score, the more the respondent to the questionnaire has a risk profile.'}, {'measure': 'Compare the effectiveness of a well-being programme in improving stress management among healthcare professionals and workers, depending on their job', 'timeFrame': '3 and 6 Months', 'description': 'Changes in the Perceived Stress Scale (PSS) according to the professions of the healthcare professionals. The PSS is a score based on the sum of the values assigned to each response of 10 different items. The minimum score is 0 and the maximum score is 50. The higher the score, the more stressed the respondent is.'}, {'measure': 'Observe the acceptability to healthcare professionals and workers of setting up a well-being programme', 'timeFrame': '3 and 6 Months', 'description': "The participation rate of the participants will be collected through a series of closed questions with multiple choice answers on the type of course taken and the dates of the follow-ups. The satisfaction rate of the participants' well-being journey will be collected through a closed question with a dichotomous answer of the Yes / No type."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['professionals and actors health'], 'conditions': ['Occupational Stress']}, 'descriptionModule': {'briefSummary': 'Participants will be selected according to their affiliation with the Paris 8 CPTS. They will be asked to complete a series of self-questionnaires to determine their stress levels and lifestyle habits. These tests will be used to define a wellness pathway for each participant in order to reduce the stress they feel at work. These wellness pathways are based around 4 distinct themes:\n\n* Diet, nutrition and micronutrition\n* Physical activity\n* Sleep\n* Stress and wellness. Participants will be follow-up at 3 and 6 months by means of self-questionnaires and advice on the programme.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Health professionals and actors affiliated to the Communauté professionnelle territoriale de santé (CPTS) Paris 8.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* People of legal age\n* Health professionals and players from the CPTS Paris 8 association:\n\n * Pharmacist,\n * Doctor\n * Midwife\n * Physiotherapist,\n * Dentist,\n * Nurse,\n * Pharmacy assistant,\n * Dietician-nutritionist,\n * Speech therapist,\n * Chiropodist,\n * Adapted physical activity teacher,\n * Medical secretary,\n * Other health service staff (maintenance, reception, general services and IT staff).\n* Persons having given their non-opposition to participate in the study.\n* Persons affiliated to a social security scheme or beneficiaries of such a scheme (article L1121-11)\n\nExclusion Criteria:\n\n* People already following a wellness programme.\n* People undergoing treatment for stress prescribed by a doctor.\n* People on sick leave or long-term leave who are no longer at work and who cannot be included in the study.\n* People with a poor understanding of spoken and/or written French.\n* Vulnerable persons in accordance with article L1121-6 of the CSP.\n* Persons subject to a legal protection measure (guardianship, curatorship) or unable to express their consent/non-opposition in accordance with article L1121-8 of the CSP or under court protection in accordance with article L1122-2 of the CSP.'}, 'identificationModule': {'nctId': 'NCT05974735', 'acronym': 'ASTRE', 'briefTitle': 'Adaptability to Stress of Healthcare Workers in the 8th Arrondissement', 'organization': {'class': 'OTHER', 'fullName': 'CPTS Paris 8'}, 'officialTitle': 'Adaptability to Stress of Healthcare Workers in the 8th Arrondissement - Evaluation of Stress Perceived by Healthcare Professionals and Workers. Real-life Prospective Study.', 'orgStudyIdInfo': {'id': 'PRO-0038'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Wellness trail', 'type': 'BEHAVIORAL', 'description': 'Setting up wellness trails based on four distinct themes:\n\n* Food, Nutrition and Micronutrition\n* Physical activity\n* Sleep\n* Stress and well-being'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75008', 'city': 'Paris', 'country': 'France', 'facility': 'CPTS Paris 8', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Eric MYON', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CPTS Paris 8'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CPTS Paris 8', 'class': 'OTHER'}, 'collaborators': [{'name': 'ICUREsearch', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}