Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT05482347 |
| Other study ID # |
19-1926 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 8, 2023 |
| Est. completion date |
May 2024 |
Study information
| Verified date |
September 2023 |
| Source |
University of Colorado, Denver |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 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.
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.
