Spinal Cord InjuryNCT07430904
Empowerment Program to Reduce Treatment of Asymptomatic Bacteriuria in Veterans With Spinal Cord Injury
A study testing Empowerment Program in people with Spinal Cord Injury and Spinal Cord Disease, run by VA Office of Research and Development at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury, Spinal Cord Disease
- What is being tested?
- Empowerment Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2027to 30 Jun 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Have not been involved in the development phase of the program
Who cannot join
- Non-Veterans
- Veterans without SCI/D or neurogenic bladder
- Patients with dementia who would not be able to provide consent or respond to interview prompts
- Patients who do not receive primary care at the MEDVAMC
- Veterans who participated in the development of the empowerment program
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030-4211
Eva Amenta, MD, (713) 440-4400, eva.amenta@va.gov
Eva Amenta, MD
About this study
Official title: Direct to Consumer Empowerment Program to Reduce Treatment of Asymptomatic Bacteriuria in Veterans With Spinal Cord Injury and Neurogenic Bladder
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.
Read the detailed description
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.
Innovation 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.
The 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.
Methodology: 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.
- Conditions
- Spinal Cord Injury, Spinal Cord Disease
- Being tested
- Empowerment Program
- Keywords
- Asymptomatic Bacteriuria, Antimicrobial Stewardship, Veteran Healthcare, Spinal Cord Injury, Spinal Cord Disease, Neurogenic Bladder
- Medical subject headings
- Spinal Cord Injuries, Spinal Cord Diseases, Urinary Bladder, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empowerment ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Pilot Program Participant | Experimental | Veterans with SCI/D and neurogenic bladder Receives: Behavioral: Empowerment Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Incontinence Quality of Life Questionnaire
Scoring: 28-item survey on a 4-point Likert scale with higher number being associated with better quality of life
Measured: 12 months
Secondary outcomes (14)
Neurogenic Bladder Symptom Score
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
Measured: 12 months
The Spinal Cord Injury - Quality of Life (SCI-QOL) survey
An 8-question short-form survey on a five-point Likert scale; higher scores indicate more bladder management difficulties
Measured: 12 months
Chew's Health Literacy Survey
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.
Measured: 6 months
Knowledge and Attitudes about Antibiotics
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.
Measured: 12 months
Weiner tool Feasibility and acceptability subscales for the empowerment program
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.
Measured: 12 months
Communication with Physicians survey
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.
Measured: 12 months
Self-Regulation Assessment
A 22-question survey scored on a five-point Likert scale; higher scores correspond to higher levels of self-regulation
Measured: 12 months
Clinical Chart Review
Conducted monthly through the time of patient study participation to assess clinic calls about urinary complaints
Measured: 12 months
Consent Rates
Consent rates will be measured as a form of feasibility and acceptability
Measured: 12 months
Clinical Chart Review (clinic visits)
Conducted monthly through the time of patient study participation to assess clinic visits
Measured: 12 months
Clinical Chart Review (ER visits)
Conducted monthly through the time of patient study participation to assess ER visits
Measured: 12 months
Clinical Chart Review (hospitalization for UTI)
Conducted monthly through the time of patient study participation to assess hospitalization for UTI
Measured: 12 months
Clinical Chart Review (antibiotic prescriptions ordered for ASB or UTI)
Conducted monthly through the time of patient study participation to assess antibiotic prescriptions ordered for ASB or UTI
Measured: 12 months
Completion Rate
Completion rates will be measured as a form of feasibility and acceptability
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start2 Aug 2027 (estimated)
- Primary completion1 Dec 2031 (estimated)
- Study completion30 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Eva Amenta, MD, Principal investigator, Michael E. DeBakey VA Medical Center, Houston, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07430904
- Sponsor's protocol ID
- RRD9-004-25M
- Other IDs
- 1IK2RD002113-01A2
- Status last verified
- Aug 2026
- First submitted
- 17 Feb 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct to Consumer Empowerment Program to Reduce Treatment of Asymptomatic Bacteriuria in Veterans With Spinal Cord Injury and Neurogenic Bladder
- ClinicalTrials.gov ID
- NCT07430904
- Acronym / sponsor ID
- RRD9-004-25M
- Conditions
- Spinal Cord Injury, Spinal Cord Disease
- Keywords
- Asymptomatic Bacteriuria, Antimicrobial Stewardship, Veteran Healthcare, Spinal Cord Injury, Spinal Cord Disease, Neurogenic Bladder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 2 Aug 2027 (estimated)
- Primary completion
- 1 Dec 2031 (estimated)
- Study completion
- 30 Jun 2032 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Innovation 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.
The 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.
Methodology: 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Pilot Program Participant | Experimental | Behavioral: Empowerment ProgramVeterans with SCI/D and neurogenic bladder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
- Have not been involved in the development phase of the program
Key exclusion criteria (5 listed)
- Non-Veterans
- Veterans without SCI/D or neurogenic bladder
- Patients with dementia who would not be able to provide consent or respond to interview prompts
- Patients who do not receive primary care at the MEDVAMC
- Veterans who participated in the development of the empowerment program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empowerment ProgramEnrolled 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. | Behavioural | Pilot Program Participant |
Primary outcome
The Incontinence Quality of Life Questionnaire
Time frame: 12 months
Scoring: 28-item survey on a 4-point Likert scale with higher number being associated with better quality of life
14 secondary outcomes
Neurogenic Bladder Symptom Score
Time frame: 12 months
The Spinal Cord Injury - Quality of Life (SCI-QOL) survey
Time frame: 12 months
Chew's Health Literacy Survey
Time frame: 6 months
Knowledge and Attitudes about Antibiotics
Time frame: 12 months
Weiner tool Feasibility and acceptability subscales for the empowerment program
Time frame: 12 months
Communication with Physicians survey
Time frame: 12 months
Self-Regulation Assessment
Time frame: 12 months
Clinical Chart Review
Time frame: 12 months
Consent Rates
Time frame: 12 months
Clinical Chart Review (clinic visits)
Time frame: 12 months
Clinical Chart Review (ER visits)
Time frame: 12 months
Clinical Chart Review (hospitalization for UTI)
Time frame: 12 months
Clinical Chart Review (antibiotic prescriptions ordered for ASB or UTI)
Time frame: 12 months
Completion Rate
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eva Amenta, MD principal investigator
Michael E. DeBakey VA Medical Center, Houston, TX
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empowerment Program in people with Spinal Cord Injury and Spinal Cord Disease, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eva Amenta, MD ((713) 440-4400, eva.amenta@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Incontinence Quality of Life Questionnaire (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.