Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-02-22 @ 7:02 AM
Study NCT ID:
NCT02846467
Status:
COMPLETED
Last Update Posted:
2016-08-10
First Post:
2016-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Information Improvement for Surgical Patients Through Portable Video Media
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011470', 'term': 'Prostatic Hyperplasia'}, {'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}], 'ancestors': [{'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000682', 'term': 'Amyloid'}], 'ancestors': [{'id': 'D046912', 'term': 'Multiprotein Complexes'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 193}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-08', 'studyFirstSubmitDate': '2016-07-22', 'studyFirstSubmitQcDate': '2016-07-22', 'lastUpdatePostDateStruct': {'date': '2016-08-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comprehension of informed consent', 'timeFrame': 'Prior to surgery'}], 'secondaryOutcomes': [{'measure': 'Comprehension of informed consent', 'timeFrame': '15 days after surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Informed consent', 'Patient Education', 'Mobile applications'], 'conditions': ['Prostatic Hyperplasia', 'Bladder Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://twitter.com/Uroweb/status/752027133837471744/photo/1', 'label': 'Abstract entitled: "MHealth (Mobile Health):The use of portable video media versus standard verbal communication in the informed consent", presented at 5th Meeting of Uro-Technology (ESUT) held in Athens, Greece'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the comprehension of the Informed consent with the Standard Verbal Communication (SVC) versus Portable Video Media (PVM).', 'detailedDescription': 'The informed consent (IC) is a fully ethical and legal consolidated requirement. IC is the voluntary authorization by a patient for surgical treatment (MeSH). The IC has to include: 1. What is and for what is it, 2. How is it made, 3. What effect will produce, 4. which patients will benefit, 5. Alternatives, 6. Risks and special situations.\n\nThe standard IC is based in written and verbal information, but the information provided is insufficient, leading to misunderstanding and even litigation.\n\nTechnology plays an important role in the improvement of IC: the portable video media, tablet, with the application (app) iURO assists the procedure through videos and illustrations.\n\nTo evaluate and measure the comprehension of the information that patients received, we elaborated and validated a "Questionnaire to evaluate the comprehension of IC" (the process was mounted as "Questionnaire for urology IC validation" in the poster session at the 17th International European Association of Urology Nurses (EAUN) Meeting, Munich-Germany).\n\nThe patients undergoing to bladder or prostate transurethral resection were selected. Afterwards they were randomized previous the interview, into two groups: patients informed by PVM with the app iUro (experimental group) versus patients with an SVC (control group). The questionnaire was used to compare the comprehension of the surgery immediately and 15 days after the surgery. The items regarding questionnaire were: information, utility of the intervention, side effects, complications, comorbidity, usefulness of information, anxiety and risks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are going to receive transurethral resection of bladder or prostate\n* Patients, women and men, older than 18 years without any mental disability\n\nExclusion Criteria:\n\n* Patients who refuse to participate in the study\n* Patients who have inability to communicate in spanish.\n* Several visual problems that limit the ability to read written material'}, 'identificationModule': {'nctId': 'NCT02846467', 'briefTitle': 'Information Improvement for Surgical Patients Through Portable Video Media', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario Puerto Real'}, 'officialTitle': 'Comparison of Understanding of Informed Consent Between Portable Video Media Versus Written Consent at Urological Surgeries.', 'orgStudyIdInfo': {'id': 'HospitalUPR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Portable video media', 'description': 'Patients who receive informed consent trough portable video media around 10 minutes', 'interventionNames': ['Other: Informed consent trough a portable video media']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional IC', 'description': 'Patients who receive traditional IC (written consent) during 10 to 15 minutes', 'interventionNames': ['Other: Written informed consent']}], 'interventions': [{'name': 'Informed consent trough a portable video media', 'type': 'OTHER', 'otherNames': ['iURO Application (App)'], 'description': 'Information provided to patients using the mobile application (iURO app)', 'armGroupLabels': ['Portable video media']}, {'name': 'Written informed consent', 'type': 'OTHER', 'otherNames': ['Traditional informed consent', 'Standard verbal communication'], 'description': 'Information provided to patient trough the traditional informed consent (written IC) for transurethral resection of bladder or prostate.', 'armGroupLabels': ['Traditional IC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11510', 'city': 'Puerto Real', 'state': 'Cadiz', 'country': 'Spain', 'facility': 'Urology Department of the University Hospital of Puerto Real', 'geoPoint': {'lat': 36.52819, 'lon': -6.19011}}], 'overallOfficials': [{'name': 'Sebastian Armijos Leon, Urologist', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario Puerto Real'}, {'name': 'Federico Rodriguez Rubio, Urologist', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Univesity of Cadiz'}, {'name': 'Jorge Rioja Zuazu, Urologist', 'role': 'STUDY_CHAIR', 'affiliation': 'Universidad de Zaragoza'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'The database with the demographic and results of the participant is going to be available during the next six months. The information will be send with an email request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario Puerto Real', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Cadiz', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Urologist', 'investigatorFullName': 'Sebastian Armijos', 'investigatorAffiliation': 'Hospital Universitario Puerto Real'}}}}