Empowerment Program to Reduce Treatment of Asymptomatic Bacteriuria in Veterans With Spinal Cord Injury
Part of paid clinical trials in Houston, Texas.
- Sponsor
- VA Office of Research and Development
- Study ID
- NCT07430904
- Status
- Not Yet Recruiting
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Conditions
- Spinal Cord Disease
- Spinal Cord Injury
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Empowerment Program — BEHAVIORALEnrolled 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.
Study Details
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.
Key Dates
- Start date
- Jul 1, 2026
- Status verified
- Apr 2026
- Primary completion
- Dec 1, 2031
- Completion
- Jun 30, 2032
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- Experimental: Pilot Program ParticipantVeterans with SCI/D and neurogenic bladder
Primary Outcome Measure
The Incontinence Quality of Life Questionnaire [ Time Frame: 12 months ]
Central Contacts
- Eva Amenta, MD(713) 440-4400
- Barbara W Trautner, MD PhD(713) 440-4438
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Michael E. DeBakey VA Medical Center, Houston, TX | Houston | Texas | 77030-4211 | Eva Amenta, MD (PRINCIPAL_INVESTIGATOR) |
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