CIC Behavioral Economics in Children With Spina Bifida

NCT05562713 | Completed DMC

• 1 other identifier: Pro00111134
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Spina Bifida; Neurogenic Bladder

Keywords

clean intermittent catheterization; spina bifida; neurogenic bladder; behavioral economics

Outcome Measures

Primary Outcomes (1)

• Number of participants with independent CIC (Clean Intermittent Catheterization)

  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

Study Arms (3)

Control (Arm #1)

NO INTERVENTION

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.

Present Bias without Loss Aversion (Arm #2)

EXPERIMENTAL

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

Present Bias with Loss Aversion (dependent on accrual) (Arm #3)

EXPERIMENTAL

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

Interventions

Present Bias without Loss Aversion BEHAVIORAL

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

Present Bias without Loss Aversion (Arm #2)

Present Bias with Loss Aversion BEHAVIORAL

Prizes only if fully independent CIC demonstrated

Present Bias with Loss Aversion (dependent on accrual) (Arm #3)

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (2)

Duke University Hospital

Durham, North Carolina, 27701, United States

Location

Lenox Baker Children's Hopsital

Durham, North Carolina, 27701, United States

Location

Related Publications (4)

• Hobbs KT, Krischak M, Tejwani R, Purves JT, Wiener JS, Routh JC. The Importance of Early Diagnosis and Management of Pediatric Neurogenic Bladder Dysfunction. Res Rep Urol. 2021 Sep 2;13:647-657. doi: 10.2147/RRU.S259307. eCollection 2021.

  PMID: 34513742 BACKGROUND

• Edwards AB, Jacobs M. Early Vs. Expectant Management of Spina Bifida Patients-Are We All Talking About a Risk Stratified Approach? Curr Urol Rep. 2019 Nov 16;20(11):76. doi: 10.1007/s11934-019-0943-z.

  PMID: 31734847 BACKGROUND

• Lapides J, Diokno AC, Silber SJ, Lowe BS. Clean, Intermittent Self-Catheterization in the Treatment of Urinary Tract Disease. J Urol. 2017 Feb;197(2S):S122-S124. doi: 10.1016/j.juro.2016.10.097. Epub 2016 Dec 21. No abstract available.

  PMID: 28012758 BACKGROUND

• Atchley TJ, Dangle PP, Hopson BD, Graham A, Arynchyna AA, Rocque BG, Joseph DB, Wilson TS. Age and factors associated with self-clean intermittent catheterization in patients with spina bifida. J Pediatr Rehabil Med. 2018;11(4):283-291. doi: 10.3233/PRM-170518.

  PMID: 30507589 BACKGROUND

MeSH Terms

Conditions

Spinal Dysraphism; Urinary Bladder, Neurogenic

Condition Hierarchy (Ancestors)

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

Study Officials

• Jonathan Routh, MD, MPH

  Duke University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: October 3, 2022
• Study Start: August 1, 2023
• Primary Completion: April 18, 2024
• Study Completion: April 18, 2024
• Last Updated: June 6, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)