Ignite Creation Date:
2025-12-17 @ 1:43 PM
Ignite Modification Date:
2025-12-23 @ 9:57 PM
Study NCT ID:
NCT02343861
Status:
COMPLETED
Last Update Posted:
2018-03-15
First Post:
2015-01-16
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effectiveness of Tailored Messages on the Usage of Emollient in Patients With Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-14', 'studyFirstSubmitDate': '2015-01-16', 'studyFirstSubmitQcDate': '2015-01-16', 'lastUpdatePostDateStruct': {'date': '2018-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of the weekly amount of emollient used', 'timeFrame': 'Two weeks', 'description': 'Parents of patients are asked to bring the emollients to each visit at which time the emollients are weighed.'}], 'secondaryOutcomes': [{'measure': 'Average daily number of emollient usage', 'timeFrame': 'Two weeks'}, {'measure': 'Average daily number of topical medication (other than emollient) usage', 'timeFrame': 'Two weeks'}, {'measure': "Investigator's Global Assessment (IGA)", 'timeFrame': 'Two weeks', 'description': "At each visit, disease severity will be assessed using the Investigator's Global Assessment (IGA)."}, {'measure': 'Eczema Area and Severity Index (EASI)', 'timeFrame': 'Two weeks', 'description': 'At each visit, disease severity will be assessed using the Eczema Area and Severity Index (EASI).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Behavioral Research', 'Emollients'], 'conditions': ['Dermatitis, Atopic']}, 'referencesModule': {'references': [{'pmid': '28566920', 'type': 'RESULT', 'citation': 'Park GY, Park HS, Cho S, Yoon HS. The Effectiveness of Tailored Education on the Usage of Moisturizers in Atopic Dermatitis: A Pilot Study. Ann Dermatol. 2017 Jun;29(3):360-362. doi: 10.5021/ad.2017.29.3.360. Epub 2017 May 11. No abstract available.'}]}, 'descriptionModule': {'briefSummary': "Atopic dermatitis is the most common chronic inflammatory skin disease in children and severely affects quality of life (QoL) of patients and their parents. The application of topical medications and emollient is the mainstay of the treatment, but complexity of the treatment and lack of self-care knowledge cause poor adherence, leading to therapeutic failure. Adequate education about the chronic disease and its treatment was known to improve the treatment adherence. There are a variety forms like generalized information leaflets and video clips for imparting information to patients and individualized tailoring education was considered more effective way to improve patients' adherence. The aim of this study is to determine the efficacy of tailored education in dermatology area, especially the emollient usage in patients with atopic dermatitis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A parent of 0-5 year old children with mild to moderate atopic dermatitis\n* 20 years of age or older\n* Apply emollient for themselves to their children with atopic dermatitis\n\nExclusion Criteria:\n\n* Parents of children with severe atopic dermatitis or showing signs of acute infection (Oozing, vesicles, edema, redness or pain)'}, 'identificationModule': {'nctId': 'NCT02343861', 'briefTitle': 'The Effectiveness of Tailored Messages on the Usage of Emollient in Patients With Atopic Dermatitis', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'The Effectiveness of Tailored Messages on the Usage of Emollient in Patients With Atopic Dermatitis: A Pilot Study', 'orgStudyIdInfo': {'id': '16-2014-154'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tailored leaflet group', 'description': 'Participants (parents of children with atopic dermatitis) receive a tailored leaflet about the detailed amount of emollients as well as general information about use of emollients.', 'interventionNames': ['Behavioral: Tailored leaflet group']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Participants (parents of children with atopic dermatitis) receive general information about use of emollients only.', 'interventionNames': ['Behavioral: Control group']}], 'interventions': [{'name': 'Tailored leaflet group', 'type': 'BEHAVIORAL', 'otherNames': ['Tailored leaflet about the adequate use of emollient'], 'description': 'Parents in intervention group will receive an patient education leaflet and watch an educational video about lifestyle recommendations, and the use of emollients. In addition to general information, parents in intervention group will also receive the tailored leaflet including the estimated amount of emollients based on the body surface area.', 'armGroupLabels': ['Tailored leaflet group']}, {'name': 'Control group', 'type': 'BEHAVIORAL', 'description': 'Participants (parents of children with atopic dermatitis) in control group will receive an patient education leaflet and watch an educational video about lifestyle recommendations, and the use of emollients.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '156-707', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Dermatology, Seoul National University Boramae Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Hyun-Sun Yoon, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Dermatology, Seoul National University Boramae Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Hyun-Sun Yoon', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}