Clinical trial NCT05482347: Educational Video for Neurogenic Bladder
Official title: Development of a Decision Aid for Parents of Children With Neurogenic Bladder Considering Surgical Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurogenic Bladder
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2022-08-01
Enrollment: 106
Sex: ALL
Minimum age (years): 0
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Comparison of average knowledge assessment scores between participants in the intervention group compared participants to the control group
timeFrame: End of study (6 months)
Secondary outcomes:
measure: Acceptability of educational video
timeFrame: End of study (6 months)
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: Children's Hospital Colorado
name: Cindy Buchanan, PhD
role: PRINCIPAL_INVESTIGATOR
References: