Educational Video for Neurogenic Bladder

University of Colorado Denver (CU Denver)

Status: Invitation-only

Conditions: Neurogenic Bladder

Treatments: Other: Educational video

Study type: Interventional

Funder types: Other

Identifiers

NCT05482347

19-1926

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: Under 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups

Control (knowledge assessment before video)

Active Comparator group

Description:

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.

Treatment:

Other: Educational video

Video (video before knowledge assessment)

Experimental group

Description:

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.

Treatment:

Other: Educational video