← Back to Search

Behavioral Economics Program for Spina Bifida

N/A
Waitlist Available
Led By Jonathan Routh, MD, MPH
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
CIC performed fully by their caregiver
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Study Summary

This trial will develop a program to incentivize early self-catheterization in children with Spina Bifida using behavioral economics, in order to increase the number of children who are able to do this independently.

Who is the study for?
This trial is for children aged 4 to 12 with Spina Bifida who currently have their catheterization done by a caregiver. They must be able to perform the task themselves as judged by their caregiver and doctor, and communicate in English.Check my eligibility
What is being tested?
The study tests a program designed to encourage kids with Spina Bifida to start self-catheterizing early. It uses behavioral economics, comparing two approaches: one with 'Present Bias' alone, another adding 'Loss Aversion'.See study design
What are the potential side effects?
Since this study focuses on behavioral interventions rather than medications or invasive procedures, there are no additional physical risks associated with participating.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have been diagnosed with spina bifida, including specific codes like Q05.0-Q05.9 in your medical records.
Select...
You need someone else to do everything for you.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clean Intermittent Catheterization

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Present Bias without Loss Aversion (Arm #2)Experimental Treatment1 Intervention
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 II: Present Bias with Loss Aversion (dependent on accrual) (Arm #3)Experimental Treatment1 Intervention
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 III: Control (Arm #1)Active Control1 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.

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,351 Previous Clinical Trials
3,409,466 Total Patients Enrolled
Jonathan Routh, MD, MPHPrincipal InvestigatorDuke University Hospital

Media Library

Present Bias with Loss Aversion Clinical Trial Eligibility Overview. Trial Name: NCT05562713 — N/A
Spina Bifida Research Study Groups: Control (Arm #1), Present Bias without Loss Aversion (Arm #2), Present Bias with Loss Aversion (dependent on accrual) (Arm #3)
Spina Bifida Clinical Trial 2023: Present Bias with Loss Aversion Highlights & Side Effects. Trial Name: NCT05562713 — N/A
Present Bias with Loss Aversion 2023 Treatment Timeline for Medical Study. Trial Name: NCT05562713 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals under 35 years of age allowed to partake in this research?

"To be eligible for this medical trial, candidates must fall within the age range of 6 to 12 years old. Separately, there are 25 trials specifically designed for youth under 18 years and 35 studies that cater to individuals over 65."

Answered by AI

How many participants have been recruited for this research project?

"Affirmative. Evidence on clinicaltrials.gov shows that this experiment, which was initially launched on November 1st 2022, is actively enlisting participants. Around 80 people need to be enrolled from 2 separate medical facilities."

Answered by AI

Is there currently an opportunity for patients to join this investigation?

"According to the data posted on clinicaltrials.gov, this medical study is currently in search of participants. It was first advertised on November 1st 2022 and last amended on November 3rd 2022."

Answered by AI

Are there any eligibility requirements for me to join this experiment?

"This clinical trial is selecting 80 individuals with a neurogenic urinary bladder between the ages of 6 and 12 years old. Participants must have one of the ICD10 codes that fall under Q05.0-Q05.9, be able to communicate fluently in English, demonstrate manual dexterity to complete CICs (as designated by their caregiver and pediatric urologist), and should possess a diagnosis of spina bifida including meningocele or myelomeningocele."

Answered by AI
~0 spots leftby Apr 2024