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CIC Behavioral Economics in Children With Spina Bifida

Primary Purpose

Spina Bifida, Neurogenic Bladder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Present Bias without Loss Aversion
Present Bias with Loss Aversion
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Spina Bifida focused on measuring clean intermittent catheterization, spina bifida, neurogenic bladder, behavioral economics

Eligibility Criteria

4 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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
  • 6-12 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 6 years old; older than 12 years of age
  • non-spina bifida patients
  • already perform independent or semi-independent CIC

Sites / Locations

  • Duke University HospitalRecruiting
  • Lenox Baker Children's HopsitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control (Arm #1)

Present Bias without Loss Aversion (Arm #2)

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

Arm Description

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.

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)

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 28, 2022
Last Updated
September 12, 2023
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT05562713
Brief Title
CIC Behavioral Economics in Children With Spina Bifida
Official Title
Leveraging Behavioral Economics to Promote Independent Clean Intermittent Catheterization in Children With Spina Bifida
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spina Bifida, Neurogenic Bladder
Keywords
clean intermittent catheterization, spina bifida, neurogenic bladder, behavioral economics

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control (Arm #1)
Arm Type
No Intervention
Arm Description
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.
Arm Title
Present Bias without Loss Aversion (Arm #2)
Arm Type
Experimental
Arm Description
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)
Arm Title
Present Bias with Loss Aversion (dependent on accrual) (Arm #3)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Present Bias without Loss Aversion
Intervention Description
Small prize for each step completed; large prize for independent CIC
Intervention Type
Behavioral
Intervention Name(s)
Present Bias with Loss Aversion
Intervention Description
Prizes only if fully independent CIC demonstrated
Primary Outcome Measure Information:
Title
Number of participants with independent CIC (Clean Intermittent Catheterization)
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan Routh, MD, MPH
Phone
9198846622
Email
jonathan.routh@duke.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Rafael Tua-Caraccia, MD
Phone
7865546150
Email
rdt25@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Routh, MD, MPH
Organizational Affiliation
Duke University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Atkinson
Email
mary.atkinson@duke.edu
First Name & Middle Initial & Last Name & Degree
John Wiener, MD
First Name & Middle Initial & Last Name & Degree
Rafael Tua-Caraccia, MD
First Name & Middle Initial & Last Name & Degree
Jonathan Routh, MD, MPH
First Name & Middle Initial & Last Name & Degree
Maryellen Kelley, NP
First Name & Middle Initial & Last Name & Degree
Leonid Aksenov, MD
Facility Name
Lenox Baker Children's Hopsital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carolina Coordinator
Email
carolina.kroniger@duke.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34513742
Citation
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.
Results Reference
background
PubMed Identifier
31734847
Citation
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.
Results Reference
background
PubMed Identifier
28012758
Citation
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.
Results Reference
background
PubMed Identifier
30507589
Citation
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.
Results Reference
background

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CIC Behavioral Economics in Children With Spina Bifida

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