Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2025-12-27 @ 1:46 AM
Study NCT ID:
NCT05056168
Status:
UNKNOWN
Last Update Posted:
2023-11-15
First Post:
2021-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of a Dermatology-Specific Treatment Satisfaction Instrument
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-11-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-14', 'studyFirstSubmitDate': '2021-09-14', 'studyFirstSubmitQcDate': '2021-09-14', 'lastUpdatePostDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Validity and reliability of a dermatology-specific treatment satisfaction instrument in patients with psoriasis', 'timeFrame': '8 months', 'description': 'For this survey study, the investigators will gather descriptive statistics for each item in the questionnaire. The investigators will also measure the following psychometric properties: measurement error, reliability and construct validity, as measured by convergent and known-groups validity'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psoriasis']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to validate a dermatology-specific questionnaire that assesses patient satisfaction with their treatments across various inflammatory dermatology diseases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Adult (≥ 18 years) dermatology patients with psoriasis from LAC+USC and Keck Medical Centers, the Brigham and Women's Hospital, and the Mount Sinai Hospital.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (≥ 18 years)\n* Psoriasis patients undergoing some form of treatment'}, 'identificationModule': {'nctId': 'NCT05056168', 'briefTitle': 'Validation of a Dermatology-Specific Treatment Satisfaction Instrument', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern California'}, 'officialTitle': 'Validation of a Dermatology-Specific Treatment Satisfaction Instrument', 'orgStudyIdInfo': {'id': 'HS-18-00891-AM004'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Dermatology-Specific Treatment Satisfaction Instrument', 'type': 'OTHER', 'description': "Study subjects will also be administered a dermatology-specific treatment satisfaction questionnaire, as well as other questionnaires including the generic validated Treatment Satisfaction Questionnaire for Medication (TSQM-9) and the validated Dermatology Life Quality Index (DLQI). Study participants will also self-report their disease severity using PGA. Depending on patients' preferred method of interacting with the study team, the investigators will collect their responses to these questionnaires either in-person, over the phone, or electronically via secure research platforms."}]}, 'contactsLocationsModule': {'locations': [{'zip': '90089', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'April Armstrong, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern California'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern California', 'class': 'OTHER'}, 'collaborators': [{'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'April Armstrong', 'investigatorAffiliation': 'University of Southern California'}}}}