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

Status: Completed
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 12
Healthy Volunteers: f
View:

• 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

Locations
United States
North Carolina
Duke University Hospital
Durham
Lenox Baker Children's Hopsital
Durham
Time Frame
Start Date: 2023-08-01
Completion Date: 2024-04-18
Participants
Target number of participants: 22
Treatments
No_intervention: Control (Arm #1)
CIC will be discussed with caretakers \& patients during their appointment and they will be given the instruction sheet to take home. They will not have a follow-up appointment scheduled. Research team will call them to check if the patient is able to perform CIC independently. If they can, a visit will be scheduled for them to demonstrate this in clinic.
Experimental: Present Bias without Loss Aversion (Arm #2)
CIC will be discussed with caretakers \& patients during their appointment and they will be given the instruction sheet to take home. Child will receive a prize (\~$5-20 in value) for every CIC step completed. They will follow-up in clinic in 3 months (or earlier) to demonstrate their CIC ability. If they can demonstrate this ability, they will receive a large prize (\~$30-50 in value)
Experimental: Present Bias with Loss Aversion (dependent on accrual) (Arm #3)
CIC will be discussed with caretakers \& patients during their appointment and they will be given the instruction sheet to take home. Child will pick a prize for every CIC step completed. They will follow-up in clinic in 3 months (or earlier) to demonstrate their CIC ability. All of the prizes that the child picked will be given only if fully-independent CIC is demonstrated.
Sponsors
Leads: Duke University

This content was sourced from clinicaltrials.gov