Incontinence and Quality of Life in Children With Spina Bifida
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|ClinicalTrials.gov Identifier: NCT03410667|
Recruitment Status : Recruiting
First Posted : January 25, 2018
Last Update Posted : August 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Spina Bifida Myelomeningocele||Behavioral: Phase One: Exploration Behavioral: Phase Two: Creation Behavioral: Phase Three: Reflection Behavioral: Aim 2||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Patient-centered Approach to Urinary Incontinence and Quality of Life in Children and Adolescents With Spina Bifida|
|Actual Study Start Date :||December 1, 2019|
|Estimated Primary Completion Date :||November 1, 2022|
|Estimated Study Completion Date :||November 1, 2022|
Standard of care arm
Behavioral: Phase One: Exploration
Spina Bifida patients from the pediatric urology clinic at Riley Hospital and their caregivers will participate in discussions of UI goals. These patients will self report their experiences and perspectives using a "Day in the Life" diary tool-kit.
Behavioral: Phase Two: Creation
Patients, caregivers and providers will work to create a goal setting tool to help patients and physicians appropriately address the issue of UI in patients with spina bifida.
Behavioral: Phase Three: Reflection
This is a validation step to test whether the goal-setting tool is widely applicable and functional in a clinic setting. There will be cognitive interviews after the tool is completed to gather patient impressions.
Experimental: Intervention Arm
Behavioral: Aim 2
This will be a large scale validation of the tool.
Other Name: Prospective Assessment of Patient-Centered Goals and HRQOL
- UI Goal [ Time Frame: 5 years ]Goals and goal attainment will be assessed using the MyGoal tool. Patients who select a UI goal will be considered to be concerned about UI and offered UI treatments. Those who do not select a UI goal will be considered not to be concerned. Self-reported goal attainment will be categorized as: attained, not attained, and goal initially not identified.
- General HRQOL (Kidscreen tool) [ Time Frame: 5 Years ]General HRQOL (secondary outcome) will be evaluated with the 27-item Kidscreen tool.83 All questionnaire scores range from 0 to 100, with higher scores indicating higher HRQOL. These data will serve as the basis for power calculations for future studies. [No additional patient-centered outcomes will be collected, so as not to overwhelm participants with lengthy questionnaires.]
- Dry Interval [ Time Frame: 5 year ]Self-reported UI will be assessed using clinically accepted criteria in SB care: a dry interval (<4h, ≥4h, always dry)
- Leak Amount [ Time Frame: 5 years ]Self-reported UI will be assessed using clinically accepted criteria in SB care: leak amount (a lot, medium, a little, none).
- SB-specific HRQOL [ Time Frame: 5 years ]The primary outcome, SB-specific HRQOL, will be evaluated using the validated 10-item QUAlity of Life ASsessment in Children/Teenagers (QUALAS-C/T).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03410667
|Contact: Chantel M Colavecchia, MDemail@example.com|
|Contact: Konrad Szymanski, MD, MHA||(317) firstname.lastname@example.org|
|United States, Indiana|
|Riley Hospital for Children||Recruiting|
|Indianapolis, Indiana, United States, 46202|
|Contact: Chantel Colavecchia 317-278-2478 email@example.com|