Ignite Creation Date:
2024-05-06 @ 6:09 PM
Last Modification Date:
2024-10-26 @ 2:42 PM
Study NCT ID:
NCT05562713
Status:
COMPLETED
Last Update Posted:
2024-06-06
First Post:
2022-09-28
Brief Title:
CIC Behavioral Economics in Children With Spina Bifida
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Leveraging Behavioral Economics to Promote Independent Clean Intermittent Catheterization in Children With Spina Bifida
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 caregiversguardians 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
This will be a prospective open label randomized control trial Patients and caregiversguardians 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 11 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 113 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None