Educational Video for Neurogenic Bladder

NCT05482347 | Completed

• 1 other identifier: 19-1926
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurogenic Bladder

Outcome Measures

Primary Outcomes (1)

• 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.

  End of study (6 months)

Secondary Outcomes (1)

• Acceptability of educational video

  End of study (6 months)

Study Arms (2)

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.

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.

Other: Educational video

Interventions

Educational video OTHER

The intervention is an educational video developed using data from focus groups of families with children diagnosed with neurogenic bladder.

Control (knowledge assessment before video); Video (video before knowledge assessment)

Eligibility Criteria

• Age: 0 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Neurogenic

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Cindy Buchanan, PhD

  Children's Hospital Colorado

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants will be masked to which arm of the study to which they are randomized.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 1, 2022
• Study Start: March 8, 2023
• Primary Completion: March 15, 2024
• Study Completion: March 15, 2024
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)