Leveraging Behavioral Economics to Promote Independent Clean Intermittent Catheterization in Children With Spina Bifida

  • STATUS
    Recruiting
  • End date
    Aug 24, 2024
  • participants needed
    80
  • sponsor
    Duke University
Updated on 24 October 2022

Summary

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.

Details
Condition Spina Bifida, Neurogenic Bladder
Treatment Present Bias without Loss Aversion, Present Bias with Loss Aversion
Clinical Study IdentifierNCT05562713
SponsorDuke University
Last Modified on24 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of spina bifida, including meningocele and myelomeningocele, as defined by International Classification of Diseases, 10th revision (ICD10). ICD-10 codes will include Q05.0-Q05.9
-12 years old
CIC performed fully by their caregiver
Demonstrate manual dexterity to perform CIC (determined by the patient's caregiver and the pediatric urologist in clinic)
Communication in English language

Exclusion Criteria

non-English speaking patients
less than 6 years old; older than 12 years of age
non-spina bifida patients
already perform independent or semi-independent CIC
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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