CIC Behavioral Economics in Children With Spina Bifida
Launched by DUKE UNIVERSITY · Sep 28, 2022
Trial Information
Current as of May 03, 2025
Completed
Keywords
ClinConnect Summary
There are three study arms to which patients will be randomized in block randomization fashion with goal recruitment totaling 45 patients. Randomization will begin with Arm 1 and Arm 2 in a 1:1 ratio for the first 20 patients, 10 patients per arm. If accrual is reasonably brisk, we will expand our recruitment to Arm 3 which will then be conducted in a 1:1:3 block randomization for the remaining 25 patients with a total of 15 patients per arm. If accrual is slow and recruitment goal will not be met by expected date, we will continue accrual to Arm 1 and Arm 2 without including Arm 3. Randomi...
Gender
ALL
Eligibility criteria
- 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
- • 4-12 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 4 years old; older than 12 years of age
- • non-spina bifida patients
- • already perform independent or semi-independent CIC
About Duke University
Duke University, a leading academic and research institution located in Durham, North Carolina, is renowned for its commitment to advancing healthcare through innovative clinical research. With a strong emphasis on interdisciplinary collaboration, Duke conducts a wide array of clinical trials aimed at developing cutting-edge therapies and improving patient outcomes across various medical fields. The university's Clinical Research Institute provides comprehensive support for trial design, implementation, and regulatory compliance, ensuring that all research adheres to the highest ethical and scientific standards. Duke’s dedication to translating research findings into effective clinical practices underscores its role as a pivotal contributor to the global medical community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Durham, North Carolina, United States
Durham, North Carolina, United States
Patients applied
Trial Officials
Jonathan Routh, MD, MPH
Principal Investigator
Duke University Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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