Ignite Creation Date:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2026-01-03 @ 6:47 PM
Study NCT ID:
NCT06435806
Status:
RECRUITING
Last Update Posted:
2025-08-03
First Post:
2024-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Medical Illustration Design Characteristic Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'We will select 10 binary distinctions of medical illustration design elements and test each in a two-arm between-subjects evaluation.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 8200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-30', 'studyFirstSubmitDate': '2024-05-21', 'studyFirstSubmitQcDate': '2024-05-24', 'lastUpdatePostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knowledge', 'timeFrame': 'Baseline and 30 minutes', 'description': 'A multiple-item knowledge test designed to test comprehension of the patient education document'}, {'measure': 'State Anxiety scale from State-Trait Anxiety Inventory', 'timeFrame': '30 minutes', 'description': 'Self-report state anxiety scale from the State-Trait Anxiety Inventory. 20 items, 4-point Likert scale. A higher score indicates more severe anxiety with a potential range from 20 to 80.'}], 'secondaryOutcomes': [{'measure': 'Satisfaction with the medical illustration', 'timeFrame': '30 minutes', 'description': 'Likert items to assess satisfaction with the document and illustration'}, {'measure': 'Reading Effort', 'timeFrame': '30 minutes', 'description': 'Likert items to assess perceived effort in reading a document and illustration'}, {'measure': 'Acceptability', 'timeFrame': '30 minutes', 'description': 'Likert items to assess acceptability and appropriateness of the illustration'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to understand what people understand from medical illustrations, and what meaning and emotions (such as anxiety) they derive from different design elements.', 'detailedDescription': 'The investigators will conduct cognitive interviews to understand the meaning laypersons obtain from different illustrations, their opinions on illustration styles, and their level of anxiety after viewing illustrations.\n\nThe investigators will also study the effect of systematically varying medical illustration designs on layperson understanding and anxiety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 18 years old\n* Speaks English or Spanish fluently\n* Is able to independently consent\n* Has adequate corrected vision to read patient education documents\n\nExclusion Criteria:\n\n\\* None'}, 'identificationModule': {'nctId': 'NCT06435806', 'briefTitle': 'Medical Illustration Design Characteristic Evaluation', 'organization': {'class': 'OTHER', 'fullName': 'Northeastern University'}, 'officialTitle': 'Advancing Medical Illustration in Patient Education Materials: From Art to Science. Study 1: Medical Illustration Design Characteristic Evaluation', 'orgStudyIdInfo': {'id': '427440'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Medical Illustration Design Distinction 1, version A', 'description': 'Medical Illustration Design Distinction 1, version A', 'interventionNames': ['Other: Medical Illustration design']}, {'type': 'EXPERIMENTAL', 'label': 'Medical Illustration Design Distinction 1, version B', 'description': 'Medical Illustration Design Distinction 1, version B', 'interventionNames': ['Other: Medical Illustration design']}, {'type': 'EXPERIMENTAL', 'label': 'Medical Illustration Design Distinction 2, version A', 'description': 'Medical Illustration Design Distinction 2, version A', 'interventionNames': ['Other: Medical Illustration design']}, {'type': 'EXPERIMENTAL', 'label': 'Medical Illustration Design Distinction 2, version B', 'description': 'Medical Illustration Design Distinction 2, version B', 'interventionNames': ['Other: Medical Illustration design']}, {'type': 'EXPERIMENTAL', 'label': 'Medical Illustration Design Distinction 3, version A', 'description': 'Medical Illustration Design Distinction 3, version A', 'interventionNames': ['Other: Medical Illustration design']}, {'type': 'EXPERIMENTAL', 'label': 'Medical Illustration Design Distinction 3, version B', 'description': 'Medical Illustration Design Distinction 3, version B', 'interventionNames': ['Other: Medical Illustration design']}, {'type': 'EXPERIMENTAL', 'label': 'Medical Illustration Design Distinction 4, version A', 'description': 'Medical Illustration Design Distinction 4, version A', 'interventionNames': ['Other: Medical Illustration design']}, {'type': 'EXPERIMENTAL', 'label': 'Medical Illustration Design Distinction 4, version B', 'description': 'Medical Illustration Design Distinction 4, version B', 'interventionNames': ['Other: Medical Illustration design']}, {'type': 'EXPERIMENTAL', 'label': 'Medical Illustration Design Distinction 5, version A', 'description': 'Medical Illustration Design Distinction 5, version A', 'interventionNames': ['Other: Medical Illustration design']}, {'type': 'EXPERIMENTAL', 'label': 'Medical Illustration Design Distinction 5, version B', 'description': 'Medical Illustration Design Distinction 5, version B', 'interventionNames': ['Other: Medical Illustration design']}, {'type': 'EXPERIMENTAL', 'label': 'Medical Illustration Design Distinction 6, version A', 'description': 'Medical Illustration Design Distinction 6, version A', 'interventionNames': ['Other: Medical Illustration design']}, {'type': 'EXPERIMENTAL', 'label': 'Medical Illustration Design Distinction 6, version B', 'description': 'Medical Illustration Design Distinction 6, version B', 'interventionNames': ['Other: Medical Illustration design']}, {'type': 'EXPERIMENTAL', 'label': 'Medical Illustration Design Distinction 7, version A', 'description': 'Medical Illustration Design Distinction 7, version A', 'interventionNames': ['Other: Medical Illustration design']}, {'type': 'EXPERIMENTAL', 'label': 'Medical Illustration Design Distinction 7, version B', 'description': 'Medical Illustration Design Distinction 7, version B', 'interventionNames': ['Other: Medical Illustration design']}, {'type': 'EXPERIMENTAL', 'label': 'Medical Illustration Design Distinction 8, version A', 'description': 'Medical Illustration Design Distinction 8, version A', 'interventionNames': ['Other: Medical Illustration design']}, {'type': 'EXPERIMENTAL', 'label': 'Medical Illustration Design Distinction 8, version B', 'description': 'Medical Illustration Design Distinction 8, version B', 'interventionNames': ['Other: Medical Illustration design']}, {'type': 'EXPERIMENTAL', 'label': 'Medical Illustration Design Distinction 9, version A', 'description': 'Medical Illustration Design Distinction 9, version A', 'interventionNames': ['Other: Medical Illustration design']}, {'type': 'EXPERIMENTAL', 'label': 'Medical Illustration Design Distinction 9, version B', 'description': 'Medical Illustration Design Distinction 9, version B', 'interventionNames': ['Other: Medical Illustration design']}, {'type': 'EXPERIMENTAL', 'label': 'Medical Illustration Design Distinction 10, version A', 'description': 'Medical Illustration Design Distinction 10, version A', 'interventionNames': ['Other: Medical Illustration design']}, {'type': 'EXPERIMENTAL', 'label': 'Medical Illustration Design Distinction 10, version B', 'description': 'Medical Illustration Design Distinction 10, version B', 'interventionNames': ['Other: Medical Illustration design']}], 'interventions': [{'name': 'Medical Illustration design', 'type': 'OTHER', 'description': 'We will test 10 binary design variants for medical illustrations (for example, with and without cut-away, with and without text labels, etc). Specific variants to be identified during first task of project.', 'armGroupLabels': ['Medical Illustration Design Distinction 1, version A', 'Medical Illustration Design Distinction 1, version B', 'Medical Illustration Design Distinction 10, version A', 'Medical Illustration Design Distinction 10, version B', 'Medical Illustration Design Distinction 2, version A', 'Medical Illustration Design Distinction 2, version B', 'Medical Illustration Design Distinction 3, version A', 'Medical Illustration Design Distinction 3, version B', 'Medical Illustration Design Distinction 4, version A', 'Medical Illustration Design Distinction 4, version B', 'Medical Illustration Design Distinction 5, version A', 'Medical Illustration Design Distinction 5, version B', 'Medical Illustration Design Distinction 6, version A', 'Medical Illustration Design Distinction 6, version B', 'Medical Illustration Design Distinction 7, version A', 'Medical Illustration Design Distinction 7, version B', 'Medical Illustration Design Distinction 8, version A', 'Medical Illustration Design Distinction 8, version B', 'Medical Illustration Design Distinction 9, version A', 'Medical Illustration Design Distinction 9, version B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Cameron Neeson', 'role': 'CONTACT', 'email': 'cameron.neeson@tuftsmedicalcenter.org', 'phone': '6176365747'}], 'facility': 'Tufts Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Madison Blain', 'role': 'CONTACT', 'email': 'm.blain@northeastern.edu', 'phone': '(617) - 858 - 6727'}], 'facility': 'Northeastern University', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Timothy Bickmore, PhD', 'role': 'CONTACT', 'email': 't.bickmore@northeastern.edu', 'phone': '6173735477'}], 'overallOfficials': [{'name': 'Timothy Bickmore, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northeastern University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'Prior to end of the study.', 'ipdSharing': 'YES', 'description': 'Transcripts from 100 cognitive interviews, and quantitative measures of comprehension and anxiety from 7,600 participant reactions to patient education documents will be generated. We will create de-identified data sets of all quantitative human subjects data that will be preserved and shared. The purpose for creating this is to allow other investigators access to the data to both validate our findings and to further advance inquiry in the field.', 'accessCriteria': 'Sharing of de-identified human subjects data will be consistent with HIPAA guidelines and the Final NIH Statement on Sharing Research Data. We do not anticipate any limitations on sharing.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northeastern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tufts Medical Center', 'class': 'OTHER'}, {'name': 'Boston University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}