The purpose of the study is to develop a comprehensive program to increase early initiation of self-catheterization in children with Spina Bifida.
This will be a prospective open label randomized control trial. Patients and caregivers/guardians in the intervention arm will be enrolled in a comprehensive program that utilizes behavioral economic theory to incentivize initiation of independent CIC. The study population will be patients aged 6 to 12 years old with diagnosis of spina bifida, including meningocele and myelomeningocele, as defined by International Classification of Diseases, 10th revision (ICD10).
This study will look at behavioral interventions. There are no additional physical risks to participation in the study. Patient demographics will be reported using descriptive statistics. Study team will use Kaplan-Meier curves to demonstrate and compare the probability of achieving independent CIC over time between the study arms.
Condition | Spina Bifida, Neurogenic Bladder |
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Treatment | Present Bias without Loss Aversion, Present Bias with Loss Aversion |
Clinical Study Identifier | NCT05562713 |
Sponsor | Duke University |
Last Modified on | 24 October 2022 |
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