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NCT05562713

CIC Behavioral Economics in Children With Spina Bifida

Completed NA Last updated 6 June 2024
What this trial tests

NA trial testing Present Bias without Loss Aversion in Spina Bifida in 22 participants. Completed in 18 April 2024.

Timeline
1 August 2023
Primary endpoint
18 April 2024
18 April 2024

Quick facts

Lead sponsorDuke University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposesupportive care
Enrollment22
Start date1 August 2023
Primary completion18 April 2024
Estimated completion18 April 2024
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Duke University

Who can join

Adults 4 to 12, any sex, with Spina Bifida or Neurogenic Bladder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 4 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Spina Bifida

Currently open trials in the same condition.

Other Duke University trials

Trials by the same sponsor.

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Data sources for this page

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