Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2026-02-22 @ 7:03 PM
Study NCT ID:
NCT00826592
Status:
COMPLETED
Last Update Posted:
2015-04-16
First Post:
2009-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Video-Based Versus Written Patient Education on Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-15', 'studyFirstSubmitDate': '2009-01-20', 'studyFirstSubmitQcDate': '2009-01-21', 'lastUpdatePostDateStruct': {'date': '2015-04-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Subjects' disease severity measured by the patient-oriented eczema measure (POEM).", 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': "Subjects'comprehension and attitude towards video-based and written education materials.", 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['patient education', 'dermatology patient education', 'atopic dermatitis', 'atopic dermatitis education', 'atopic eczema', 'infantile eczema', 'hand eczema'], 'conditions': ['Atopic Dermatitis', 'Atopic Eczema', 'Infantile Eczema', 'Hand Eczema']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ucdmc.ucdavis.edu/dermatology/research/clinical', 'label': 'University of California-Davis Department of Dermatology Clinical Research'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to compare the effect of video-based patient education with written instruction on subjects' knowledge of atopic dermatitis and their disease severity, measured by the Patient-oriented Eczema Measure (POEM), after viewing the educational materials.", 'detailedDescription': "We plan to conduct a randomized, controlled trial comparing the effect of video-based patient education with written instruction on subjects' understanding of atopic dermatitis and their disease severity.\n\nSubjects randomized to the video-based education arm will be instructed to watch a video on the classifications, aggravating factors, and treatment of atopic dermatitis. Subjects randomized to the written education arm will receive written information on the classifications, aggravating factors, and treatment of atopic dermatitis. The contents of the video and the written educational materials will be comparable.\n\nAt the end of the study period, 3 months later, subjects will be interviewed regarding their comprehension and attitude towards video-based and written education materials. Additionally, we will use the Patient-oriented Eczema Measure (POEM) questionnaire to assess the difference in subjects' disease severity between the 2 arms."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older at time of consent, may be men or women.\n* Able to adhere to the study visit schedule and other protocol requirements.\n* Capable of giving informed consent.\n\nExclusion Criteria:\n\n* Non-English speaking individuals.'}, 'identificationModule': {'nctId': 'NCT00826592', 'briefTitle': 'Comparison of Video-Based Versus Written Patient Education on Atopic Dermatitis', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Comparison of Video-based Versus Written Patient Education on Atopic Dermatitis', 'orgStudyIdInfo': {'id': '200816693-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Video-based education arm', 'description': 'Subjects receiving the video-based educational material', 'interventionNames': ['Other: Patient Educational Materials']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Written education arm:', 'description': 'Subjects receiving the written educational material', 'interventionNames': ['Other: Patient Educational Materials']}], 'interventions': [{'name': 'Patient Educational Materials', 'type': 'OTHER', 'otherNames': ['Patient educational materials on atopic dermatitis'], 'description': 'In the experimental arm, the intervention is the video-based patient educational material on atopic dermatitis. In the active comparison arm (control arm), the comparison intervention is written patient educational material on atopic dermatitis.', 'armGroupLabels': ['Video-based education arm', 'Written education arm:']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95816', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California Davis Department of Dermatology', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'overallOfficials': [{'name': 'April Armstrong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Davis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}