Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT00883220
Status:
COMPLETED
Last Update Posted:
2012-09-18
First Post:
2009-04-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Self Management in Urinary Catheter Users
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016055', 'term': 'Urinary Retention'}, {'id': 'D001750', 'term': 'Urinary Bladder, Neurogenic'}, {'id': 'D002908', 'term': 'Chronic Disease'}], 'ancestors': [{'id': 'D014555', 'term': 'Urination Disorders'}, {'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'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073278', 'term': 'Self-Management'}, {'id': 'D015190', 'term': 'Blood Glucose Self-Monitoring'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D001774', 'term': 'Blood Chemical Analysis'}, {'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003940', 'term': 'Diagnostic Techniques, Endocrine'}, {'id': 'D008991', 'term': 'Monitoring, Physiologic'}, {'id': 'D000085263', 'term': 'Self-Testing'}, {'id': 'D012648', 'term': 'Self Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 202}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-17', 'studyFirstSubmitDate': '2009-04-15', 'studyFirstSubmitQcDate': '2009-04-15', 'lastUpdatePostDateStruct': {'date': '2012-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptomatic urinary tract infection', 'timeFrame': 'every two months for 12 months'}], 'secondaryOutcomes': [{'measure': 'Urinary catheter quality of life', 'timeFrame': '6 months and 12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['self management', 'chronic condition', 'urinary catheter'], 'conditions': ['Urinary Retention', 'Neurogenic Bladder']}, 'referencesModule': {'references': [{'pmid': '26938358', 'type': 'DERIVED', 'citation': 'Wilde MH, Crean HF, McMahon JM, McDonald MV, Tang W, Brasch J, Fairbanks E, Shah S, Zhang F. Testing a Model of Self-Management of Fluid Intake in Community-Residing Long-term Indwelling Urinary Catheter Users. Nurs Res. 2016 Mar-Apr;65(2):97-106. doi: 10.1097/NNR.0000000000000140.'}, {'pmid': '25502058', 'type': 'DERIVED', 'citation': 'Wilde MH, McMahon JM, McDonald MV, Tang W, Wang W, Brasch J, Fairbanks E, Shah S, Zhang F, Chen DG. Self-management intervention for long-term indwelling urinary catheter users: randomized clinical trial. Nurs Res. 2015 Jan-Feb;64(1):24-34. doi: 10.1097/NNR.0000000000000071.'}]}, 'descriptionModule': {'briefSummary': 'Learning to self-manage urine flow may help people prevent or minimize persistent complications from long-term indwelling urethral or suprapubic catheters.', 'detailedDescription': 'Urinary catheter users commonly experience adverse health effects, such as urinary tract infection (UTI), blockage, dislodgement, and leakage, leading to poor quality of life indicators. Catheter-related problems often require health care utilization resulting in increased health care costs. Self-management of urine flow is an essential part of self-care for people with long-term urinary catheters and may lead to prevention or reduction of catheter-related problems and improved quality of life.This study tests the effectiveness of a urinary catheter self-management intervention in a randomized trial of 220 patients, with 12 months of follow-up. The experimental intervention is designed to enhance self-management of urine flow in individuals with long-term urinary catheters, with the goal of decreasing catheter related complications and enhancing quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have an indwelling urethral or suprapubic catheter and expect to use it for at least one year.\n* Live in Central or Western New York State (Utica to Buffalo regions approximately)OR are cared for by the Visiting Nurse Service of New York City.\n* Able to complete study measurements alone or with the help of a family member or caregiver.\n* Able to communicate with the study personnel in English.\n* Have access to a telephone for data collection.\n\nExclusion Criteria:\n\n* Terminally ill\n* Cognitively impaired\n* No catheter associated UTI within the previous 12 months NOR blockage NOR dislodgement in the previous 6 months(only in people who have had the catheter for 12 months or more)'}, 'identificationModule': {'nctId': 'NCT00883220', 'briefTitle': 'Self Management in Urinary Catheter Users', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'Self-management of Urine Flow in Long-term Urinary Catheter Users', 'orgStudyIdInfo': {'id': '1R01NR010553-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01NR010553-01', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': '1R01NR010553-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01NR010553-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Self-management of urinary catheter', 'description': 'Intervention: Self-management group--teaching behavioral approaches(awareness, self-monitoring, and self-management) to prevent or minimize urinary catheter complications.', 'interventionNames': ['Behavioral: Self-management of urinary catheter']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care 2', 'description': 'Usual care for urinary catheter. Home care and/or clinic care is the usual care for people with long-term urinary catheters.'}], 'interventions': [{'name': 'Self-management of urinary catheter', 'type': 'BEHAVIORAL', 'otherNames': ['self-management', 'self-monitoring', 'urinary catheter self care'], 'description': 'Awareness, self-monitoring, and self-management of urine flow are taught. Focus is on attaining adequate and consistent levels of fluid intake and preventing catheter dislodgement.', 'armGroupLabels': ['Self-management of urinary catheter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10001', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Center for Home Care Policy & Research, Visiting Nurse Service of New York', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Urinary of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'overallOfficials': [{'name': 'Mary H. Wilde, RN, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rochester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'collaborators': [{'name': 'Visiting Nurse Service of New York', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Mary Wilde', 'investigatorAffiliation': 'University of Rochester'}}}}