- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06909552
Use of an Educational Video to Improve Adherence to Treatment in Voiding Dysfunction
Use of an Educational Video to Improve Caregiver Knowledge, Adherence to Recommendations, and Outcomes in Children With Dysfunctional Voiding
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study aims to explore whether the use of an educational video on voiding dysfunction, a common urinary dysfunction, leads to improve parents and child perceived adherence to behavioral treatment recommendations. Our main hypothesis explores whether there is improved perceived adherence, and whether this improved perceived adherence leads to better symptom outcomes in this condition.
We do so through randomizing patients to a control and intervention group, where the latter is exposed to the educational video, while the control group experiences standard of care visits/follow-ups. Data is collected through surveys pre and post exposure to the intervention.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Marguerite Korber, CPNP
- Phone Number: 720-777-6523
- Email: marguerite.korber@childrenscolorado.org
Study Contact Backup
- Name: Jen Pyrzanowski
- Email: jennifer.pyrzanowski@cuanschutz.edu
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- University of Colorado Anschutz
-
Contact:
- Jennifer Pyrzanowski
- Phone Number: 303-724-0769
- Email: jennifer.pyrzanowski@cuanschutz.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Parents and Caregivers of pediatric urology patients with a diagnosis of Dysfunctional voiding (minimum 100 participants)
- 5-18 years old, no younger than 5 and no older than 18 years old
- Potty-trained - fully independent with toileting, can complete every step of the process and can do so satisfactorily by themselves.
Exclusion Criteria:
- Children with Voiding dysfunctionDysfunctional voiders with medically complex conditions (neurogenic bladder, POTS, EDS, etc.)
- Parent's child is notNot a first-time patient (i.e. has been seen in the past for dysfunctional voiding)
- Child has severeSevere intellectual disability, developmental delay, or cognitive impairment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Educational Video
Participants will be exposed to a short 3-minute educational video following a visit with their urology provider.
|
The educational video is a short 3-minute video which describes the condition in detail, at the level that a parent or child could understand without a medical background.
|
|
No Intervention: Control
Participants will not be exposed to an educational video; rather, they will receive standard of care education in clinic regarding behavioral treatment modalities at home.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived Adherence
Time Frame: 4 weeks, 8 weeks.
|
Participants will take the TAPQ perceived adherence assessment at time points 4 weeks and 8 weeks.
|
4 weeks, 8 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Video Acceptability
Time Frame: 0 weeks.
|
Immediately after watching the educational video, participants will be asked to complete a questionnaire on the acceptability of the video.
this will occur at time frame 0 weeks (for intervention group).
|
0 weeks.
|
|
Dysfunctional Voiding Scoring System
Time Frame: 0 weeks, 4 weeks, and 8 weeks.
|
Participants will be asked to complete a DVSS survey at timepoints 0 weeks, 4 weeks, and 8 weeks.
This DVSS survey will be used to assess symptom improvement throughout the study.
|
0 weeks, 4 weeks, and 8 weeks.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Feldman AS, Bauer SB. Diagnosis and management of dysfunctional voiding. Curr Opin Pediatr. 2006 Apr;18(2):139-47. doi: 10.1097/01.mop.0000193289.64151.49.
- Dyson PA, Beatty S, Matthews DR. An assessment of lifestyle video education for people newly diagnosed with type 2 diabetes. J Hum Nutr Diet. 2010 Aug;23(4):353-9. doi: 10.1111/j.1365-277X.2010.01077.x. Epub 2010 May 20.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 24-1255
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dysfunctional Voiding
-
Halic UniversityCompleted
-
Buddhist Tzu Chi General HospitalCompleted
-
Tanta UniversityRecruitingChildren | Biofeedback | Dysfunctional Voiding | Medical TreatmentEgypt
-
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training...Active, not recruitingDysfunctional Voiding | Biofeedback Therapy | Giggle IncontinenceTurkey (Türkiye)
-
Izmir University of EconomicsHealth Institutes of TurkeyActive, not recruitingChildren | Ultrasound | Pelvic Floor Muscle Training | Dysfunctional Voiding | DNSTurkey (Türkiye)
-
Tanta UniversityRecruitingChildren | Dysfunctional Voiding | Local Injection | Botulinium Toxin-A | Refractory Nocturnal EneuresisEgypt
-
University of NisNot yet recruitingDiaphragmatic Breathing Exercises and Pelvic Floor Retraining in Children With Dysfunctional VoidingDysfunctional VoidingSerbia
-
Seoul National University HospitalActive, not recruitingBowel Dysfunction | Bladder Dysfunction | Pediatric Urology | Dysfunctional VoidingKorea, Republic of
-
University of Massachusetts, WorcesterCompletedPostoperative Pain | Dysfunctional VoidingUnited States
-
Duke UniversityCompletedUrinary Dysfunction | Dysfunctional VoidingUnited States
Clinical Trials on Educational Video on Voiding Dysfunction
-
Tulane UniversityCompleted
-
Women and Infants Hospital of Rhode IslandCompleted
-
Emory UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
Assuta Ashdod HospitalRecruitingPain | Urinary Retention | UTI | Post-void Residual Volume | RecatheterizationIsrael
-
University of Texas Southwestern Medical CenterCompletedQuality of Life | Musculoskeletal Pain | Work Related Stress | GripUnited States
-
China Medical University HospitalRecruiting
-
Universidade do PortoCompletedMigraine Disorders | Exercise | Health Education | Surveys and Questionnaires | Audiovisual AidsPortugal
-
University of PittsburghCompletedContraception BehaviorUnited States
-
Universitat de LleidaEnrolling by invitationChronic Nonspecific Low Back PainSpain
-
St. Joseph's Healthcare HamiltonNot yet recruitingBody Image | Eating, Healthy