Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-03-01 @ 4:12 PM
Study NCT ID:
NCT04263805
Status:
UNKNOWN
Last Update Posted:
2020-02-11
First Post:
2020-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Vignette-based Randomized Controlled Trial to Evaluate the Impact of Research Climate on Research Practices of Doctoral Students
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-05-03', 'releaseDate': '2023-11-27'}], 'estimatedResultsFirstSubmitDate': '2023-11-27'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'It is not possible to blind participants to the intervention. However, participants will be blinded to the study hypothesis.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-10', 'studyFirstSubmitDate': '2020-02-07', 'studyFirstSubmitQcDate': '2020-02-10', 'lastUpdatePostDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mean preference score', 'timeFrame': 'Immediate assessment', 'description': 'In each vignette, participants will have to indicate which solution they prefer on a semantic differential scale, rated from - 5 to -1 (preference for solution A) and from 1 to 5 (preference for solution B).'}], 'secondaryOutcomes': [{'measure': 'proportion of students who chose the detrimental research practice (DRP)', 'timeFrame': 'Immediate assessment', 'description': 'Proportion of students rated from -5 to -1 for the DRP.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['The Study Focus on no Specific Condition']}, 'referencesModule': {'references': [{'pmid': '37773192', 'type': 'DERIVED', 'citation': "Nguyen VT, Sharp MK, Superchi C, Baron G, Glonti K, Blanco D, Olsen M, Vo Tat TT, Olarte Parra C, Neveol A, Hren D, Ravaud P, Boutron I. Biomedical doctoral students' research practices when facing dilemmas: two vignette-based randomized control trials. Sci Rep. 2023 Sep 29;13(1):16371. doi: 10.1038/s41598-023-42121-1."}]}, 'descriptionModule': {'briefSummary': "This study aims to evaluate the impact of research climate on PhD students' research practice (i.e., an environment where their peer (i.e., a post-doc researcher) had detrimental practice in a similar situation)", 'detailedDescription': "PhD students are the next generation of researchers and will present the field in the future. However, several environmental factors might influence their research practice. In this study, the investigators will evaluate the impact of research climate on PhD students' research practice (exposure to an environment where their peers commit a detrimental practice).\n\nObjective: To evaluate the impact of research climate on PhD students' research practice\n\nDesign: A randomized controlled trial\n\n1. Intervention: Participants will be shown two case vignettes describing dilemma situations in research reported with and without research climate factor.\n2. Participants: The participants will be PhD students in all biomedical disciplines.\n3. Sample size will be 300 participants\n4. Primary outcome: In each vignette, participants will have to indicate which solution they prefer on a semantic differential scale, rated from - 5 to -1 (preference for solution A) and from 1 to 5 (preference for solution B). Participants will be forced to make a choice between the 2 solutions. The primary outcome will be the mean preference score.\n5. This study is approved by ethics review regulations by INSERM (CEEI-IRB): IRB00003888"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PhD students in biomedical disciplines\n\nExclusion Criteria:\n\n* NA'}, 'identificationModule': {'nctId': 'NCT04263805', 'briefTitle': 'A Vignette-based Randomized Controlled Trial to Evaluate the Impact of Research Climate on Research Practices of Doctoral Students', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'A Vignette-based Randomized Controlled Trial to Evaluate the Impact of Research Climate on Research Practices of Doctoral Students Facing Dilemma Situations', 'orgStudyIdInfo': {'id': 'ISB-013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vignette with research climate', 'description': 'Participants in this arm will receive vignettes describing a dilemma situation in research (e.g adding honorary author) with additional sentence describing research climate (i.e. an environment where their peer had detrimental practice in a similar situation)', 'interventionNames': ['Other: Vignette with emphasis on research climate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vignette without research climate', 'description': 'Participants in this arm will receive vignettes describing a dilemma situation in research without the additional sentence describing research climate', 'interventionNames': ['Other: Vignette with emphasis on research climate']}], 'interventions': [{'name': 'Vignette with emphasis on research climate', 'type': 'OTHER', 'description': 'A vignette describing a dilemma situation for a researcher (e.g. adding an honorary author) with or without a research environment factor (i.e. an environment where other researchers commit detrimental research practice)', 'armGroupLabels': ['Vignette with research climate', 'Vignette without research climate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75181', 'city': 'Paris', 'country': 'France', 'facility': "Centre d'Epidémiologie Clinique, hôpital Hôtel Dieu, Assistance Publique-Hôpitaux de Paris", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Isabelle BOUTRON, Pr', 'role': 'CONTACT', 'email': 'isabelle.boutron@aphp.fr', 'phone': '+33 (0)1.42.34.78.33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-11-27', 'type': 'RELEASE'}, {'date': '2024-05-03', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Assistance Publique - Hôpitaux de Paris'}}}}