CIC Behavioral Economics in Children With Spina Bifida

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.

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Key information

Conditions

Spina Bifida Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Nervous System Diseases Nervous System Malformations Neural Tube Defects Neurogenic Bladder Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Dysraphism Urinary Bladder Diseases Urinary Bladder, Neurogenic Urogenital Diseases Urologic Diseases

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Hospital, Durham, North Carolina, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Present Bias without Loss Aversion

Behavioral

Small prize for each step completed; large prize for independent CIC

Present Bias with Loss Aversion

Behavioral

Prizes only if fully independent CIC demonstrated

Primary outcomes

Number of participants with independent CIC (Clean Intermittent Catheterization)

Time frame: 3 months

Upon notification from the caregiver that a child is ready to demonstrate self-CIC, they will come to the Duke Pediatric Urology or Duke Spina Bifida Clinic and meet with study personnel. Participating children will be given supplies and asked to perform CIC in private. Prior to CIC, they will have a bladder scan to measure the pre-CIC bladder volume. After they perform CIC, another bladder scan will be performed to evaluate the post-CIC bladder volume. An adequate post-CIC volume will be defined as less than 20% of the age-appropriate bladder volume.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Oct 3, 2022
Registry last updated: Jun 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed