CIC Behavioral Economics in Children With Spina Bifida

March 5, 2024 updated by: Duke University

Leveraging Behavioral Economics to Promote Independent Clean Intermittent Catheterization 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27701
        • Duke University Hospital
      • Durham, North Carolina, United States, 27701
        • Lenox Baker Children's Hopsital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
Behavioral: Present Bias without Loss Aversion
Small prize for each step completed; large prize for independent CIC
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.
Behavioral: Present Bias with Loss Aversion
Prizes only if fully independent CIC demonstrated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Jonathan Routh, MD, MPH, Duke University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

September 28, 2022

First Submitted That Met QC Criteria

September 28, 2022

First Posted (Actual)

October 3, 2022

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00111134

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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