Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-28 @ 9:24 AM
Study NCT ID:
NCT06384066
Status:
WITHDRAWN
Last Update Posted:
2024-11-26
First Post:
2024-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mobile Health Application to Improve Patient Satisfaction After Urethroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014525', 'term': 'Urethral Stricture'}], 'ancestors': [{'id': 'D014524', 'term': 'Urethral Obstruction'}, {'id': 'D014522', 'term': 'Urethral Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-10-04', 'size': 9077970, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-03-01T13:15', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The study team will not pursue this study moving forward. There have been no patients enrolled and the project will not continue. Study has been terminated with the IRB.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-09-28', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-09-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-22', 'studyFirstSubmitDate': '2024-02-19', 'studyFirstSubmitQcDate': '2024-04-22', 'lastUpdatePostDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improve patient satisfaction, education and reported outcomes', 'timeFrame': '0 to 3 months', 'description': 'Asses through Patient reported outcome measurement survey, Urethral Stricture Symptom and Impact Measurement and Patient-Reported Outcomes Measurement information System 29-item profile (PROMIS) which assesses pain intensity using a 0-10 rating item, with higher scores being a worse outcome.'}, {'measure': 'Change in rate of patient phone calls and messages', 'timeFrame': '0 to 12 months', 'description': 'assess through chart review to evaluate the number of chart messages and phone calls'}, {'measure': 'Rate of emergency department visits', 'timeFrame': '0 to 12 months', 'description': 'Assess through chart review and patient reporting events.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Urethral Stricture']}, 'descriptionModule': {'briefSummary': 'Create a custom urethroplasty mobile application that will guide patients through through the surgical process.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Have a Urethral stricture and are under going urethroplasty surgery\n\nExclusion Criteria:\n\n* Patients that do not have mobile phone capabilities\n* Patients who have physical or cognitive impairment when using a mobile phone or answering questionnaires\n* Inability to provide consent to the study'}, 'identificationModule': {'nctId': 'NCT06384066', 'briefTitle': 'Mobile Health Application to Improve Patient Satisfaction After Urethroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Evaluation of a Mobile Health Application to Improve Patient Satisfaction and Outcomes After Urethroplasty: a Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'STU00219774'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Standard of Care', 'description': 'Standard Care', 'interventionNames': ['Other: Standard of Care']}, {'type': 'OTHER', 'label': 'Standard Care + GetWell App', 'interventionNames': ['Other: GetWell Mobile Application', 'Other: Standard of Care']}], 'interventions': [{'name': 'GetWell Mobile Application', 'type': 'OTHER', 'description': 'GetWell utilizes an interactive health care application to allow patients to participate in their care. We plan to work with GetWell to develop a custom built plan for urethroplasty patients and provide patient education.', 'armGroupLabels': ['Standard Care + GetWell App']}, {'name': 'Standard of Care', 'type': 'OTHER', 'description': 'Office Based Pathway', 'armGroupLabels': ['Standard Care + GetWell App', 'Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ziho Lee', 'investigatorAffiliation': 'Northwestern University'}}}}