NCT05562713

CIC Behavioral Economics in Children With Spina Bifida

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 4 Years – 12 Years
• Healthy volunteers: Not accepted

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 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.

Detailed description

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. Randomization will be performed via NIH clinical trial randomization tool.

Conditions

• Spina Bifida
• Neurogenic Bladder

Interventions

Type	Name	Description
BEHAVIORAL	Present Bias without Loss Aversion	Small prize for each step completed; large prize for independent CIC
BEHAVIORAL	Present Bias with Loss Aversion	Prizes only if fully independent CIC demonstrated

Timeline

• Start date: 2023-08-01
• Primary completion: 2024-04-18
• Completion: 2024-04-18
• First posted: 2022-10-03
• Last updated: 2024-06-06

Locations

2 sites across 1 country: United States