Ignite Creation Date:
2025-12-24 @ 1:42 PM
Ignite Modification Date:
2026-02-25 @ 8:16 PM
Study NCT ID:
NCT05625295
Status:
COMPLETED
Last Update Posted:
2023-07-20
First Post:
2022-11-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tele-dermatology Non-presential (TeleDermaSA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-19', 'studyFirstSubmitDate': '2022-11-13', 'studyFirstSubmitQcDate': '2022-11-21', 'lastUpdatePostDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Derivation rates per 10,000 h.', 'timeFrame': '1 year', 'description': 'number of patients referred to the dermatology office'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Teledermatology', 'Primary Care']}, 'referencesModule': {'references': [{'pmid': '38914974', 'type': 'DERIVED', 'citation': 'Sanchez-Martin E, Moreno-Sanchez I, Moran-Sanchez M, Perez-Martin M, Martin-Morales M, Garcia-Ortiz L. Store-and-forward teledermatology in a Spanish health area significantly increases access to dermatology expertise. BMC Prim Care. 2024 Jun 24;25(1):227. doi: 10.1186/s12875-024-02479-1.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the implementation of the Non-Face-to-Face Interconsultation of dermatology since it began to be used in August 2020 until August 2022 in the province of Salamanca (Spain)', 'detailedDescription': 'Design: cross-sectional descriptive study. Subjects: The unit of analysis will be the NPIs performed in dermatology since its implementation in August 2020 until the present time in the health area of Salamanca. To analyze the face-to-face consultations to analyze the differences. A random sample of 500 PNCIs and 500 face-to-face consultations will be extracted.\n\nMeasurements: To analyze the ICNP and face-to-face IC to dermatology registered in the computerized clinical history made in PC from Medora and registered in Jimena. To record the number of consultations, type of pathology referred, dermatology response time, discharges after assessment, face-to-face consultations required, delay time, treatment required, follow-up required or not, diagnostic coincidence, quality of the photographic image sent.\n\nA differentiated analysis will be made according to the use or not of the dermatoscope, type of center (urban, semi-urban and rural), gender of the patients and age groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The unit of analysis will be the PNCIs performed in dermatology from Primary Care, registered in Medora software, with its corresponding photographic file, and its response in Jimena software of the dermatology service, from June 2021 to June 2022, one year. A random sample stratified by type of center (urban, semi-urban and rural) will be extracted.\n\nA control group of face-to-face consultations will be used, in a similar number (500) obtained randomly, and also stratified by type of center, which will be used to compare the information from the NCIs.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The unit of analysis will be the PNCIs performed in dermatology from Primary Care, registered in Medora software, with its corresponding photographic file, and its response in Jimena software of the dermatology service, from June 2021 to June 2022, one year.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05625295', 'acronym': 'TeleDermaSA', 'briefTitle': 'Tele-dermatology Non-presential (TeleDermaSA)', 'organization': {'class': 'OTHER', 'fullName': 'Fundacion para la Investigacion y Formacion en Ciencias de la Salud'}, 'officialTitle': 'Evaluation of the Implementation of Tele-dermatology, in Its Modality of Non-presential Inter-consultation, in the Province of Salamanca.', 'orgStudyIdInfo': {'id': '116'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with non-face-to-face consultation', 'description': 'A sample of 500 patients who have undergone non-face-to-face consultation with dermatology', 'interventionNames': ['Other: data collection protocol in clinical history']}, {'label': 'Patients with face-to-face consultation', 'description': 'A sample of 500 patients who have undergone face-to-face consultation with dermatology', 'interventionNames': ['Other: data collection protocol in clinical history']}], 'interventions': [{'name': 'data collection protocol in clinical history', 'type': 'OTHER', 'description': 'collection of data from the clinical history according to the established protocol', 'armGroupLabels': ['Patients with face-to-face consultation', 'Patients with non-face-to-face consultation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37003', 'city': 'Salamanca', 'country': 'Spain', 'facility': 'Centro de Salud La Alamedilla', 'geoPoint': {'lat': 40.96882, 'lon': -5.66388}}], 'overallOfficials': [{'name': 'Luis G Garcia Ortiz, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'FUNDACION INFOSALUD'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundacion para la Investigacion y Formacion en Ciencias de la Salud', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Luis Garcia Ortiz', 'investigatorAffiliation': 'Fundacion para la Investigacion y Formacion en Ciencias de la Salud'}}}}