Neurogenic BladderNCT05482347
Educational Video for Neurogenic Bladder
A study testing Educational video in people with Neurogenic Bladder, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study is designed to assess the efficacy of educational materials in parents of children with neurogenic bladder considering surgical reconstruction. Focus groups were conducted with neurogenic bladder patients and their families in which participants were asked questions about expectations, fears, medical… Read more about this study
- Who is it for?
- Ages 0 to 99 years
- Conditions the study is for
- Neurogenic Bladder
- What is being tested?
- Educational video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2023to 15 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 0 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- English-speaking parents/and or primary caregivers of children 18 years old or younger with a diagnosis of neurogenic bladder who have received care at Children's Hospital Colorado, but have not undergone a major surgery for the treatment of neurogenic bladder
Who cannot join
- Parent/caregiver does not speak English
- Children who have undergone a major surgery for the treatment of neurogenic bladder (ex. urinary diversion)
- Patients greater than 18 years old
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
Official title: Development of a Decision Aid for Parents of Children With Neurogenic Bladder Considering Surgical Reconstruction
This study is designed to assess the efficacy of educational materials in parents of children with neurogenic bladder considering surgical reconstruction. Focus groups were conducted with neurogenic bladder patients and their families in which participants were asked questions about expectations, fears, medical understanding, unexpected challenges, and persistent questions regarding reconstructive surgery for neurogenic bladder. Analysis of this qualitative data was used to create educational materials (such as animated videos) and decision-making tools for families of children with neurogenic bladders who are trying to decide what treatment option is right for them, and to better prepare them for what lies ahead. This study specifically aims to investigate the effect of an educational video on participants' knowledge of neurogenic bladder and surgical management.
Read the detailed description
Within pediatric urology, some of the most complex and consequential decision-making surrounds surgical management of the neurogenic bladder. There is strong evidence that more informed patients are more adherent, more engaged, more likely to fully consider the risks and benefits of different treatment options, and ultimately more satisfied with their clinical outcome. In practice, patient education is time-consuming, inconsistent, and often complicated by language barriers and varying levels of medical literacy. A potential solution to overcoming the barriers to educating patients and families on these complex issues lies in patient decision aids and quality medical educational videos.
The investigators, using qualitative data obtained from focus groups with patient families, developed an educational video on neurogenic bladder for patients and their families. This study will assess the efficacy of the educational video by utilizing a knowledge questionnaire that is administered to participants who have been and who have not been exposed to the video. The investigators will identify all patients between the ages of 0 and 18 years old who have a diagnosis of neurogenic bladder, but have not undergone any surgical treatment for neurogenic bladder. All eligible patients' caregivers will be invited to participate in this study, which will be administered virtually via a REDCap survey that is disseminated by email. Patients' caregivers will provide consent electronically, after which they will be randomized into a control or intervention arm. Randomization will be stratified by age groups (0-4 years, 5-11 years, and 12 years and older). These age groups were defined based on patients' independence regarding ability to manage their diagnosis (i.e., 0-4 years represents patients before toilet training; 5-11 years represents patients who are school-aged but still require adult supervision; and 12 years and older represents patients who have relatively increased independence). Participants in the control arm will take the knowledge questionnaire, then watch the educational video, while participants in the intervention arm will watch the educational video prior to taking the knowledge questionnaire. Both groups will be asked to provide feedback on the educational video afterwards. The investigator will determine the average knowledge questionnaire score within each group (control and intervention) and compare the two averages.
- Conditions
- Neurogenic Bladder
- Being tested
- Educational video
- Medical subject headings
- Urinary Bladder, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational videoOther
The intervention is an educational video developed using data from focus groups of families with children diagnosed with neurogenic bladder.
| Study group | Role | What they receive |
|---|---|---|
| Control (knowledge assessment before video) | Active comparator | The patient will complete the knowledge assessment, then they will be presented with the educational video. After watching the video, they will complete the acceptability scale questionnaire and will be asked to select a gift card preference at the end of the survey. Receives: Other: Educational video |
| Video (video before knowledge assessment) | Experimental | The patient will be presented with the educational video, then they will complete the knowledge assessment and the acceptability scale questionnaire. They will be asked to select a gift card preference at the end of the survey. Receives: Other: Educational video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of average knowledge assessment scores between participants in the intervention group compared participants to the control group
The knowledge assessment consists of 6 multiple choice questions, each with 4 answer choices, regarding participants' knowledge on the condition of neurogenic bladder. The questionnaire will be scored based on how many questions the participants correctly answer and an average score will be calculated for the intervention group and the control group. Average scores for each of the predefined age groups will also be calculated and compared within the control and intervention groups.
Measured: End of study (6 months)
Secondary outcomes (1)
Acceptability of educational video
The acceptability scale consists of 12 questions (multiple choice questions, free responses, and rating questions) asking participants for feedback regarding the educational video, as well as suggestions on how to improve the video for future patients. One question, formatted as a yes/no question, will be used to assess the acceptability of the education video and asks participants if they would recommend the educational video to other parents/families of children with neurogenic bladder at different times over the course of diagnosis.
Measured: End of study (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start8 Mar 2023
- Primary completion15 Mar 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurogenic BladderStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cindy Buchanan, PhD, Principal investigator, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05482347
- Sponsor's protocol ID
- 19-1926
- Status last verified
- Apr 2025
- First submitted
- 28 Jul 2022
- Last updated
- 16 Apr 2025
- 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 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Decision Aid for Parents of Children With Neurogenic Bladder Considering Surgical Reconstruction
- ClinicalTrials.gov ID
- NCT05482347
- Acronym / sponsor ID
- 19-1926
- Conditions
- Neurogenic Bladder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 8 Mar 2023 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 1 Aug 2022 (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.
This study is designed to assess the efficacy of educational materials in parents of children with neurogenic bladder considering surgical reconstruction. Focus groups were conducted with neurogenic bladder patients and their families in which participants were asked questions about expectations, fears, medical understanding, unexpected challenges, and persistent questions regarding reconstructive surgery for neurogenic bladder. Analysis of this qualitative data was used to create educational materials (such as animated videos) and decision-making tools for families of children with neurogenic bladders who are trying to decide what treatment option is right for them, and to better prepare them for what lies ahead. This study specifically aims to investigate the effect of an educational video on participants' knowledge of neurogenic bladder and surgical management.
Detailed description
Within pediatric urology, some of the most complex and consequential decision-making surrounds surgical management of the neurogenic bladder. There is strong evidence that more informed patients are more adherent, more engaged, more likely to fully consider the risks and benefits of different treatment options, and ultimately more satisfied with their clinical outcome. In practice, patient education is time-consuming, inconsistent, and often complicated by language barriers and varying levels of medical literacy. A potential solution to overcoming the barriers to educating patients and families on these complex issues lies in patient decision aids and quality medical educational videos.
The investigators, using qualitative data obtained from focus groups with patient families, developed an educational video on neurogenic bladder for patients and their families. This study will assess the efficacy of the educational video by utilizing a knowledge questionnaire that is administered to participants who have been and who have not been exposed to the video. The investigators will identify all patients between the ages of 0 and 18 years old who have a diagnosis of neurogenic bladder, but have not undergone any surgical treatment for neurogenic bladder. All eligible patients' caregivers will be invited to participate in this study, which will be administered virtually via a REDCap survey that is disseminated by email. Patients' caregivers will provide consent electronically, after which they will be randomized into a control or intervention arm. Randomization will be stratified by age groups (0-4 years, 5-11 years, and 12 years and older). These age groups were defined based on patients' independence regarding ability to manage their diagnosis (i.e., 0-4 years represents patients before toilet training; 5-11 years represents patients who are school-aged but still require adult supervision; and 12 years and older represents patients who have relatively increased independence). Participants in the control arm will take the knowledge questionnaire, then watch the educational video, while participants in the intervention arm will watch the educational video prior to taking the knowledge questionnaire. Both groups will be asked to provide feedback on the educational video afterwards. The investigator will determine the average knowledge questionnaire score within each group (control and intervention) and compare the two averages.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control (knowledge assessment before video) | Active comparator | Other: Educational videoThe patient will complete the knowledge assessment, then they will be presented with the educational video. After watching the video, they will complete the acceptability scale questionnaire and will be asked to select a gift card preference at the end of the survey. |
| Video (video before knowledge assessment) | Experimental | Other: Educational videoThe patient will be presented with the educational video, then they will complete the knowledge assessment and the acceptability scale questionnaire. They will be asked to select a gift card preference at the end of the survey. |
Who may qualify
- Ages
- 0 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- English-speaking parents/and or primary caregivers of children 18 years old or younger with a diagnosis of neurogenic bladder who have received care at Children's Hospital Colorado, but have not undergone a major surgery for the treatment of neurogenic bladder
Key exclusion criteria (3 listed)
- Parent/caregiver does not speak English
- Children who have undergone a major surgery for the treatment of neurogenic bladder (ex. urinary diversion)
- Patients greater than 18 years old
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 |
|---|---|---|
| Educational videoThe intervention is an educational video developed using data from focus groups of families with children diagnosed with neurogenic bladder. | Other | Control (knowledge assessment before video), Video (video before knowledge assessment) |
Primary outcome
Comparison of average knowledge assessment scores between participants in the intervention group compared participants to the control group
Time frame: End of study (6 months)
The knowledge assessment consists of 6 multiple choice questions, each with 4 answer choices, regarding participants' knowledge on the condition of neurogenic bladder. The questionnaire will be scored based on how many questions the participants correctly answer and an average score will be calculated for the intervention group and the control group. Average scores for each of the predefined age groups will also be calculated and compared within the control and intervention groups.
1 secondary outcome
Acceptability of educational video
Time frame: End of study (6 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: No
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Pediatric Locomotor Training Bladder Study
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Concomitant Renal and Urinary Bladder Allograft Transplantation
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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. This study is not recruiting at the moment.
Cindy Buchanan, PhD principal investigator
Children's Hospital Colorado
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational video in people with Neurogenic Bladder, run by University of Colorado, Denver 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 16 Apr 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of average knowledge assessment scores between participants in the intervention group compared participants to the control group (time frame: End of study (6 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 16 Apr 2025.