Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2026-02-03 @ 7:27 AM
Study NCT ID:
NCT02918656
Status:
COMPLETED
Last Update Posted:
2019-06-04
First Post:
2016-09-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Presenting Summary Information From Cochrane Systematic Reviews
Sponsor:
Organization:
Raw JSON
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The total score is the sum of scores on all five answers (minimum score was 10 and maximum 50). Higher scores indicate greater reading experience, which means that a person was assessed that type of reading material as more enjoyable. 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'description': 'Scientific abstract presentation of health information\n\nScientific abstract presentation of health information: The students in scientific abstract group will read the the text written for the academic population and practitioners.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '60'}, {'groupId': 'FG002', 'numSubjects': '57'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '60'}, {'groupId': 'FG002', 'numSubjects': '57'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '57', 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written for the academic population and practitioners.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000', 'lowerLimit': '19', 'upperLimit': '21'}, {'value': '19', 'groupId': 'BG001', 'lowerLimit': '19', 'upperLimit': '20'}, {'value': '19', 'groupId': 'BG002', 'lowerLimit': '19', 'upperLimit': '21'}, {'value': '19', 'groupId': 'BG003', 'lowerLimit': '19', 'upperLimit': '21'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '142', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Heard of Cochrane systematic reviews', 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Used Cochrane library', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Primary source of health information', 'classes': [{'categories': [{'title': 'Internet', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}]}, {'title': 'Family Members', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}]}, {'title': 'Family physician', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}]}, {'title': 'Library', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'Other', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-09-30', 'size': 213864, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-10-05T03:33', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 171}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-01', 'studyFirstSubmitDate': '2016-09-27', 'resultsFirstSubmitDate': '2018-02-17', 'studyFirstSubmitQcDate': '2016-09-27', 'lastUpdatePostDateStruct': {'date': '2019-06-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-06-01', 'studyFirstPostDateStruct': {'date': '2016-09-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Understanding', 'timeFrame': 'One-hour after the intervention', 'description': 'The primary outcome of the study is the score on a understanding test with ten questions about information contained in all three forms of presentation, titled as "Understanding information about external cephalic version for breech presentation before term" (Hutton et al, 2015). The questions will focus on understanding the benefits and risks of the intervention and the quality of evidence described in the systematic review. Each correctly answered question will be awarded one point, with a maximum of 10 points. The scale was specifically designed for this research, they ask about the information contained in all three abstract format and all questions are open-ended.'}], 'secondaryOutcomes': [{'measure': 'Reading Experience', 'timeFrame': 'One hour after the intervention', 'description': 'This section of the survey will include 5 questions about the experience of participants about the text they read, measured on a 10-point Likert type scale, where 1 means do not agree at all and 10 means fully agree. The total score is the sum of scores on all five answers (minimum score was 10 and maximum 50). Higher scores indicate greater reading experience, which means that a person was assessed that type of reading material as more enjoyable. So, higher scores are associated with more positive reading experience.'}, {'measure': 'Accessibility of Relevant Information', 'timeFrame': 'One hour after the intervention', 'description': 'This section of the survey will have 5 questions concerning how easy it was for the participant to find relevant information, measured by a 10-point Likert type scale where the answer 1 means I do not agree at all and 10 means I fully agree. The total score is the sum of scores on all the answers (minimum score was 5, maximum 50). The higher score indicated that the reading material was perceived as more user friendly and that it was easier to find the desired information.'}, {'measure': 'Health Numeracy Score', 'timeFrame': 'One hour after the intervention', 'description': 'This section will use 6-item General health numeracy test (Osborne et al., 2013) in order to determine how much our participants understand the basic health instructions regarding numeracy dimension. For each correct answer, the participants receive one point and the total score is the sum of all correct answers.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cochrane', 'Abstract', 'Infographics', 'Understanding'], 'conditions': ['Understanding Cochrane Systematic Reviews']}, 'descriptionModule': {'briefSummary': 'The objective of the investigators study is to evaluate the efficacy of infographics in presenting information, in terms of understanding and remembering research results, compared to standard PLS formats and scientific summary formats (SciSum).', 'detailedDescription': 'The investigators will conduct a randomized control trial (RCT) with three different formats of the same systematic review summary (infographics, PLS and scientific summary). The content of these three formats is based on the same systematic review, but the ways of data presentation will differ: visual presentation, plain language, and scientific language. The trial will be performed at the beginning of the 2016/2017 academic year, with first year university students as participants. The trial will be voluntary and anonymous. The survey will consist of 4 parts: 1) demographic data, 2) one format of the summary (randomly assigned), 3) comprehension test of the information given in the summary, 4) accessibility of information and overall satisfaction with the given summary assessed by survey and 5) health numeracy test. All materials will be in Croatian. The materials used in this research will be assessed by experts in order to confirm face validity of developed questions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eligible participants will be first-year university students without experience with Cochrane review summaries, because prior familiarization with Cochrane summaries could make information uptake easier by those participants.\n\nExclusion criteria:\n\n* Participants who give the positive answer to the survey question about familiarity with the Cochrane will be excluded from the study analysis.'}, 'identificationModule': {'nctId': 'NCT02918656', 'briefTitle': 'Presenting Summary Information From Cochrane Systematic Reviews', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of Split'}, 'officialTitle': 'Presenting Summary Information From Cochrane Systematic Reviews: Randomized Controlled Trial of Infographics Presentation vs. Standard Word Summaries', 'orgStudyIdInfo': {'id': 'IP-2014-09-7672'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Infographics', 'description': 'Infographic presentation of health information', 'interventionNames': ['Other: Infographic presentation of health information']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Plain Language Summary', 'description': 'PLS presentation of health information', 'interventionNames': ['Other: PLS presentation of health information']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Scientific abstract', 'description': 'Scientific abstract presentation of health information', 'interventionNames': ['Other: Scientific abstract presentation of health information']}], 'interventions': [{'name': 'Infographic presentation of health information', 'type': 'OTHER', 'description': 'The students in this group will read Cochrane systematic review summary in infographics format.\n\nInfographics format is a form of visual presentation of results of systematic review, supported by pictures and graphs.', 'armGroupLabels': ['Infographics']}, {'name': 'PLS presentation of health information', 'type': 'OTHER', 'description': 'The students randomized in PLS group will read text format with simple explanation of the survey topic main findings which is intended for lay audience.', 'armGroupLabels': ['Plain Language Summary']}, {'name': 'Scientific abstract presentation of health information', 'type': 'OTHER', 'description': 'The students in scientific abstract group will read the the text written for the academic population and practitioners.', 'armGroupLabels': ['Scientific abstract']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21000', 'city': 'Split', 'country': 'Croatia', 'facility': 'School of Medicine', 'geoPoint': {'lat': 43.50891, 'lon': 16.43915}}], 'overallOfficials': [{'name': 'Ana Marušić, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor at Medical School of Split'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will be collected electronically, using the SurveyMonkey platform. The data will be fully anonymous and will be kept on a secure server of the School of Medicine.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of Split', 'class': 'OTHER'}, 'collaborators': [{'name': 'Croatian Science Foundation', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD student', 'investigatorFullName': 'Ivan Buljan', 'investigatorAffiliation': 'University Hospital of Split'}}}}