CIC Behavioral Economics in Children With Spina Bifida

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2024-04-18

Brief Summary

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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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Detailed Description

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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.

Conditions

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Spina Bifida Neurogenic Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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)

Group Type EXPERIMENTAL

Present Bias without Loss Aversion

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Present Bias with Loss Aversion

Intervention Type BEHAVIORAL

Prizes only if fully independent CIC demonstrated

Interventions

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Present Bias without Loss Aversion

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

Intervention Type BEHAVIORAL

Present Bias with Loss Aversion

Prizes only if fully independent CIC demonstrated

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

4 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No