Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:23 AM
Study NCT ID:
NCT07430904
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-24
First Post:
2026-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Empowerment Program to Reduce Treatment of Asymptomatic Bacteriuria in Veterans With Spinal Cord Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D001750', 'term': 'Urinary Bladder, Neurogenic'}], 'ancestors': [{'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D001745', 'term': 'Urinary Bladder 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'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Patients meeting our study criteria will be recruited for the pilot from the MEDVAMC SCI/D clinics. These criteria include Veterans with SCI/D and neurogenic bladders, who have been treated for at least one UTI in the past year, have access to a telephone, and have not been involved in the development phase of the program (Aims 1 and 2).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2032-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-17', 'studyFirstSubmitDate': '2026-02-17', 'studyFirstSubmitQcDate': '2026-02-17', 'lastUpdatePostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Incontinence Quality of Life Questionnaire', 'timeFrame': '12 months', 'description': 'Scoring: 28-item survey on a 4-point Likert scale with higher number being associated with better quality of life'}], 'secondaryOutcomes': [{'measure': 'Neurogenic Bladder Symptom Score', 'timeFrame': '12 months', 'description': 'A 24-item questionnaire that measures bladder symptoms over three domains; graded on a 4-point Likert scale. higher scores are associated with worse symptom burden or quality of life'}, {'measure': 'The Spinal Cord Injury - Quality of Life (SCI-QOL) survey', 'timeFrame': '12 months', 'description': 'An 8-question short-form survey on a five-point Likert scale; higher scores indicate more bladder management difficulties'}, {'measure': "Chew's Health Literacy Survey", 'timeFrame': '6 months', 'description': 'A three-question survey that is scored on a five-point Likert scale, with a maximum score of 15 and a minimum score of 3; higher scores correlate to poor health literacy and low scores indicate high health literacy.'}, {'measure': 'Knowledge and Attitudes about Antibiotics', 'timeFrame': '12 months', 'description': 'Modeled off the WHO Multi-country antibiotic awareness campaign as well as a survey used for attitudes and behavior surrounding antibiotic use in providers of SCI/D developed by Skelton et al. - This is a single survey. For attitudes and Behavior questions scal goes from strongly disagree to strongly agree with lower scores associated with disagreement. Knowledge will be measured based on responses to questions with less or incorrect answers associated with less knowledge.'}, {'measure': 'Weiner tool Feasibility and acceptability subscales for the empowerment program', 'timeFrame': '12 months', 'description': 'An eight-question survey scored on a five-point Likert scale, higher scores indicate the intervention is feasible to use and acceptable. Scoring Instructions: Scales can be created for each measure by averaging responses. Scale values range from 1 to 5. No items need to be reverse coded. Lower scores are associated with less acceptability or feasibility.'}, {'measure': 'Communication with Physicians survey', 'timeFrame': '12 months', 'description': 'Three questions urevey on a 5-point Likert scale. Score each item as the number circled. If more than one consecutive number is circled, code the lower number (less communication). If the numbers are not consecutive, do not score the item. The score is the mean of the three items. If more than one is missing, set the value of the score for the scale to missing. A higher score indicates better communication with physicians.'}, {'measure': 'Self-Regulation Assessment', 'timeFrame': '12 months', 'description': 'A 22-question survey scored on a five-point Likert scale; higher scores correspond to higher levels of self-regulation'}, {'measure': 'Clinical Chart Review', 'timeFrame': '12 months', 'description': 'Conducted monthly through the time of patient study participation to assess clinic calls about urinary complaints'}, {'measure': 'Consent Rates', 'timeFrame': '12 months', 'description': 'Consent rates will be measured as a form of feasibility and acceptability'}, {'measure': 'Clinical Chart Review (clinic visits)', 'timeFrame': '12 months', 'description': 'Conducted monthly through the time of patient study participation to assess clinic visits'}, {'measure': 'Clinical Chart Review (ER visits)', 'timeFrame': '12 months', 'description': 'Conducted monthly through the time of patient study participation to assess ER visits'}, {'measure': 'Clinical Chart Review (hospitalization for UTI)', 'timeFrame': '12 months', 'description': 'Conducted monthly through the time of patient study participation to assess hospitalization for UTI'}, {'measure': 'Clinical Chart Review (antibiotic prescriptions ordered for ASB or UTI)', 'timeFrame': '12 months', 'description': 'Conducted monthly through the time of patient study participation to assess antibiotic prescriptions ordered for ASB or UTI'}, {'measure': 'Completion Rate', 'timeFrame': '12 months', 'description': 'Completion rates will be measured as a form of feasibility and acceptability'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Asymptomatic Bacteriuria', 'Antimicrobial Stewardship', 'Veteran Healthcare', 'Spinal Cord Injury', 'Spinal Cord Disease', 'Neurogenic Bladder'], 'conditions': ['Spinal Cord Injury', 'Spinal Cord Disease']}, 'descriptionModule': {'briefSummary': 'Antimicrobial resistance is a major public health concern that worsens healthcare outcomes. Antibiotic resistant organisms occur more often in Veterans with spinal cord injury or disease (SCI/D) given their frequent exposure to antibiotics, recurrent hospitalizations, and common use of urinary catheter devices. Veterans with SCI/D are also at risk for overtreatment with antibiotics when they do not need them, particularly for over-diagnosed urinary tract infections. The investigators plan to create a patient empowerment program with input of Veterans with SCI/D \\[and their providers\\] to help guide their decisions and next steps when they have a change in bladder symptoms. The program will give Veterans with SCI/D the tools to speak up to their provider and advocate for themselves to avoid receiving unnecessary antibiotics. This program is highly innovative, as it puts Veterans with SCI/D in charge of thoughtful antibiotic use, or antibiotic stewardship.', 'detailedDescription': "It is estimated that 42,000 Veterans are living with spinal cord injury or disease (SCI/D), 27,000 of whom are cared for by the VA each year. Individuals with SCI/D and neurogenic bladder are at increased risk for infections from antibiotic-resistant bacteria due to many factors, including repeated exposure to healthcare settings, healthcare-associated pathogens, and antibiotics, as well as the frequent presence of medical devices (e.g., urinary catheters).\\] These issues are a cause for concern, as rising rates of antibiotic resistance are a major public health issue, and healthcare outcomes are worse in patients with infections from antibiotic-resistant organisms. A primary reason for high rates of antibiotic usage among those with SCI/D and neurogenic bladder is bacterial colonization of the bladder (i.e., bacteriuria), which is common in these individuals due to urinary retention and urinary catheters and often treated with antibiotics despite guidelines recommending against this practice. In particular, treatment of bladder colonization without signs/symptoms of infection, known as asymptomatic bacteriuria (ASB), is not recommended as antibiotics do not improve clinical outcomes and contribute to antibiotic resistance. However, despite efforts to reduce the frequency of treatment for ASB among providers, treatment rates remain high, and nearly half of the courses of antibiotics prescribed for suspected UTIs in those with neurogenic bladders are for the inappropriate treatment of ASB.\n\nInnovation and Impact: The investigators propose to address this problem by developing an empowerment intervention for Veterans with SCI/D and neurogenic bladder to help them interact with their providers about their bladder health and advocate for themselves when they do not need antibiotics. This intervention will include direct-to-consumer marketing material to engage Veterans with SCI/D and empowerment training via role-playing for Veterans to use when discussing suspected UTI with their providers. Specific Aims: The investigators will develop and pilot this Veteran-focused, Veteran-led antibiotic stewardship program through a mixed-methods research design.\n\nThe investigators will pilot test the direct-to-consumer patient empowerment program, role-playing activities, and marketing materials among Veterans with SCI/D and neurogenic bladders and their providers.\n\nMethodology: This study employs qualitative and quantitative data techniques, such as semi-structured interviews, focus groups, quantitative surveys and outcome measures, and a pilot study. The primary outcome of the pilot study is the assessment of Veterans' self-reported quality of life specific to urinary incontinence via the Incontinence Quality of Life Questionnaire. Secondary outcomes include bladder symptom burden via Neurogenic Bladder Symptom Score, feasibility and acceptability of the intervention to Veterans with SCI/D via the Weiner survey, functional outcomes (with emphasis on bladder function), knowledge and attitudes about antibiotics, communication with providers, and response to marketing materials. Path to Translation/ Implementation: This work will lay the groundwork for a future randomized controlled trial testing the program's effectiveness at reducing unnecessary antibiotic treatment of ASB in Veterans with SCI/D. More broadly, empowering Veterans and their caregivers to engage with their providers and advocate for their health is integral to the PI's long-term goal of becoming a VA clinician-investigator recognized for advancing innovative approaches to antimicrobial stewardship in rehabilitation populations."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Veterans with SCI/D and neurogenic bladders who have been treated for at least one UTI in the past year\n* Have access to a telephone\n* Have not been involved in the development phase of the program\n\nExclusion Criteria:\n\n* Non-Veterans\n* Veterans without SCI/D or neurogenic bladder\n* Patients with dementia who would not be able to provide consent or respond to interview prompts\n* Patients who do not receive primary care at the MEDVAMC\n* Veterans who participated in the development of the empowerment program'}, 'identificationModule': {'nctId': 'NCT07430904', 'briefTitle': 'Empowerment Program to Reduce Treatment of Asymptomatic Bacteriuria in Veterans With Spinal Cord Injury', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Direct to Consumer Empowerment Program to Reduce Treatment of Asymptomatic Bacteriuria in Veterans With Spinal Cord Injury and Neurogenic Bladder', 'orgStudyIdInfo': {'id': 'RRD9-004-25M'}, 'secondaryIdInfos': [{'id': '1IK2RD002113-01A2', 'type': 'OTHER_GRANT', 'domain': 'RRD&T'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pilot Program Participant', 'description': 'Veterans with SCI/D and neurogenic bladder', 'interventionNames': ['Behavioral: Empowerment Program']}], 'interventions': [{'name': 'Empowerment Program', 'type': 'BEHAVIORAL', 'description': "Enrolled participants will receive the program via email and/or mail. In addition, participants will be contacted by a member of the research team to conduct empowerment training. This training will entail walking the participant through the training manual and each of the program's materials. Training will also include an access plan for Veterans to employ when they have genitourinary symptoms and education on how to use the bladder symptom-assessment decision-support aid (the MedStar Urinary Symptom Questionnaire bladder symptom-assessment tool). The access plan will suggest that the Veteran review the empowerment program when they have concerning genitourinary symptoms and decide how they will contact their provider or health care nurse. In addition, a time will be set up for participants to engage in role-playing with a member of the research team to trial the use of the empowerment tool as it should be used in a clinical setting.", 'armGroupLabels': ['Pilot Program Participant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030-4211', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'contacts': [{'name': 'Eva Amenta, MD', 'role': 'CONTACT', 'email': 'eva.amenta@va.gov', 'phone': '713-440-4400'}, {'name': 'Eva Amenta, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Michael E. DeBakey VA Medical Center, Houston, TX', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Eva Amenta, MD', 'role': 'CONTACT', 'email': 'eva.amenta@va.gov', 'phone': '(713) 440-4400'}, {'name': 'Barbara W Trautner, MD PhD', 'role': 'CONTACT', 'email': 'barbara.trautner@va.gov', 'phone': '(713) 440-4438'}], 'overallOfficials': [{'name': 'Eva Amenta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Michael E. DeBakey VA Medical Center, Houston, TX'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}