Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-30 @ 8:15 PM
Study NCT ID:
NCT05414435
Status:
COMPLETED
Last Update Posted:
2022-06-15
First Post:
2022-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Informed Consent in Endoscopy: Read, Understood or Merely Signed?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 232}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-12', 'studyFirstSubmitDate': '2022-06-05', 'studyFirstSubmitQcDate': '2022-06-08', 'lastUpdatePostDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessing the percentage of patients who adequate read informed consent forms', 'timeFrame': '12 months', 'description': 'Assess if patients "adequately read" informed consent forms - "adequate reading" was defined by checking all of the following: signing of informed consent form; fulfilment of a questionnaire regarding medical history and drugs; underlining a small sentence added to the orignial version of informed consent form.\n\nPatients not meeting all the defined criteria were considered not to have adequately read the informed consent.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Informed Consent', 'Gastrointestinal Endoscopy']}, 'descriptionModule': {'briefSummary': 'Informed consent form is a legal document that, ethically, should be obtained before any endoscopic procedure is performed.\n\nThe main purpose of this research study is to assess the readability, comprehensibility and applicability of the new informed consent proposed by the Portuguese Society of Digestive Endoscopy as a way to standardize the information provided to patients prior to endoscopic exams.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients refered for elective endoscopic procedures', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients able to autonomously give informed consent\n* Patients refered to elective endoscopic procedures (upper digestive endoscopy and/or colonoscopy) without deep sedation.\n\nExclusion Criteria:\n\n* Patients refered to urgent endoscopic procedures\n* Patients refered for endoscopic procedures with deep sedation'}, 'identificationModule': {'nctId': 'NCT05414435', 'briefTitle': 'Informed Consent in Endoscopy: Read, Understood or Merely Signed?', 'organization': {'class': 'OTHER', 'fullName': 'Centro Hospitalar Tondela-Viseu'}, 'officialTitle': 'Informed Consent in Endoscopy: Read, Understood or Merely Signed?', 'orgStudyIdInfo': {'id': 'CHTV07/2022.1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Reading of informed consent form', 'type': 'BEHAVIORAL', 'description': 'Patients that adequately read informed consent forms'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3504-509', 'city': 'Viseu', 'country': 'Portugal', 'facility': 'Centro Hospitalar Tondela Viseu', 'geoPoint': {'lat': 40.66165, 'lon': -7.90905}}], 'overallOfficials': [{'name': 'Ricardo A Cardoso, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centro Hospitalar Tondela-Viseu, E.P.E.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro Hospitalar Tondela-Viseu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ana Carvalho', 'investigatorAffiliation': 'Centro Hospitalar Tondela-Viseu'}}}}