Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2026-01-01 @ 7:50 PM
Study NCT ID:
NCT01804868
Status:
COMPLETED
Last Update Posted:
2014-04-21
First Post:
2013-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Web Tutorial Based on Case Vignettes for Teaching Literature Critical Assessment to Nursing Students
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 506}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-17', 'studyFirstSubmitDate': '2013-03-04', 'studyFirstSubmitQcDate': '2013-03-04', 'lastUpdatePostDateStruct': {'date': '2014-04-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "student's knowledge of critical assessment of randomized controlled trials", 'timeFrame': '21 days', 'description': "student's score on an evaluation case vignette with multiple choice questionnaires (range 0-25)"}], 'secondaryOutcomes': [{'measure': "student's quality perception of the tutorial", 'timeFrame': '21 days', 'description': 'measured on a 5-point Likert scale'}, {'measure': "student's acceptance of the tutorial", 'timeFrame': '21 days', 'description': 'measured on a 5-point Likert scale'}, {'measure': "Impact of the tutorial on student's perception of research participation", 'timeFrame': '21 days', 'description': 'Question: "After completing this training, would you participate / recommend a close member or a patient to participate to a randomized controlled trial?\' Answers will be measured on a 5-point Likert scale.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['case vignette', 'nurse', 'critical assessment', 'randomized controlled trial'], 'conditions': ['New Educational Technologies']}, 'descriptionModule': {'briefSummary': "Objective: The aim of this study is to assess the efficacy of a web tutorial based on case vignettes as a complementary tool for teaching literature critical assessment to nursing students, in terms of: 1) knowledge, 2) tutorial quality and acceptability and 3) students' point of view on research participation.\n\nParticipants: Nursing second-year students from 3 universities in Paris (Paris Descartes University, Paris Diderot University and Paris 13 Nord).\n\nDesign: A randomized controlled trial will assess the teaching efficacy of a case vignettes based tutorial compared to no tutorial. In order to preserve a minimal blinding of participants, the comparator will be a basic passive teaching presentation on internet. The students will be randomized in two parallel groups. They will be evaluated on a final case vignette, and will be invited to follow the other intervention after evaluation. The allocation of participants will be done by a computerized randomization list, the sequence will be created by an independent statistician with a ratio 1: 1: 1. Since the students follow courses in different nursing institutes for each university which may have different teaching content and organization, the randomization will be stratified by nursing institute. Allocation concealment will be provided because only the statistician will have access to the randomization list. All the participants will receive an individual mail linking them to his group dedicated website. In order to preserve a minimal blinding of participants, the comparator will be a passive presentation and the participants will not be informed of the intervention evaluated and will have the opportunity to follow the other intervention after the evaluation. In parallel, both groups will follow normally their university courses.\n\nIntervention: A case vignette is a clinical scenario based on clinical practice. It will ask a clinical problem the student will have to answer by reading a research article on a randomized clinical trial. Then he will have to answer questions about this article which are related to the major methodological points of a randomized trial. All these steps are available on a secure website.\n\nOutcomes: The primary endpoint will be the student's knowledge of critical assessment of randomized controlled trials. It will be measured by students' score on an evaluation case vignette with multiple choice questionnaires. The secondary endpoints will be the quality perception and acceptance of the tutorial and if the tutorial has modified their perception of research participation. Responses will be ranged by a 5-point Likert scale.\n\nPotential interests: This study takes place in the field of nursing universitary teaching. Nursing students have entered recently the universitary education system which enhances the nursing research, an emerging field in France.\n\nThe investigators hope that this complementary teaching tool will enhance the knowledge and participation of nurses in research.\n\nSample size expected: 506 participants.", 'detailedDescription': "Statistical analysis :\n\nQualitatives variables will be presented with the number and percentage of participants and of missing data for each outcome. Quantitative variables will be presented with the number and percentage of participants, mean, standard deviation and range. Assymetrical variables will be presented with the median and the interquartile range.\n\nQuantitative outcomes will be compared between groups with a Fisher test in a linear mixed model. (the fixed effect will be the allocation group and the random effect will be the nursing institute so as to take into account the similarity of the students for each institute).\n\nQualitative outcomes will be compared using a mixed effect logistic regression model (the fixed effect will be the allocation group and the random effect will be the nursing institute so as to take into account the similarity of the students for each institute).\n\nThe data analysis will be carried out as an 'intention-to treat analysis' in all randomized participants.\n\nFor the primary outcome, missing data will be dealt with the multiple imputation method. Sensibility analysis will be used to confirm the results for the primary outcome.\n\nTwo-tailed tests will be applied at a standard level of 5%. The statistical analysis will be performed with SAS 9.3 statistical software."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* second-year students who have completed teaching modules on clinical research methodology.\n\nExclusion Criteria:\n\n* none.'}, 'identificationModule': {'nctId': 'NCT01804868', 'briefTitle': 'Web Tutorial Based on Case Vignettes for Teaching Literature Critical Assessment to Nursing Students', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Efficacy of a Web Tutorial Based on Case Vignettes for Teaching Literature Critical Assessment to Nursing Students: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'RAV005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'case vignette tutorial', 'description': 'The web tutorial composed of 4 case vignettes.', 'interventionNames': ['Other: case vignette tutorial']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'passive web presentation on research regulation', 'description': 'The presentation will be a web-based voice commented video presentation on research regulation.', 'interventionNames': ['Other: passive web presentation on research regulation']}], 'interventions': [{'name': 'case vignette tutorial', 'type': 'OTHER', 'otherNames': ['case vignette tutorial for teaching literature critical appraisal to nursing students'], 'description': 'The web tutorial will be composed of 4 case vignettes. A case vignette is a clinical scenario based on clinical practice. It will ask a clinical problem the student will have to answer by reading a research article on a randomized clinical trial. Then he will have to answer questions about this article which are related to the major methodological points of a randomized trial. All these steps are available on a secured website.', 'armGroupLabels': ['case vignette tutorial']}, {'name': 'passive web presentation on research regulation', 'type': 'OTHER', 'description': 'The presentation will be a web-based voice commented video presentation on research regulation. It will allow to preserve a minimal blinding of participants, since the participants will not be informed of the intervention evaluated and will have the opportunity to follow the other intervention after the evaluation.', 'armGroupLabels': ['passive web presentation on research regulation']}]}, '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}}], 'overallOfficials': [{'name': 'Isabelle Boutron, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}, {'name': 'Philippe Ravaud, MD, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}