Ignite Creation Date:
2024-05-06 @ 2:34 PM
Last Modification Date:
2024-10-26 @ 1:33 PM
Study NCT ID:
NCT04358302
Status:
COMPLETED
Last Update Posted:
2024-07-15
First Post:
2020-04-16
Brief Title:
Individual Patient Exposure and Response in Pediatric Lupus
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Individual Patient Exposure and Response in Pediatric Lupus
Status:
COMPLETED
Status Verified Date:
2024-07
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:
iPERSONAL
Brief Summary:
The purpose of this research study is to see if an electronic pill bottle cap can help children and teens with systemic lupus better remember to take their medicine It will also gather information on the best dose of hydroxychloroquine Plaquenil for children and teens Participants in this study will continue to take their usual medication as prescribed by their doctors Participants will receive an electronic pill bottle cap a smartphone and a Fitbit Over 6 months a nurse will visit each participant 4 times to ask questions about symptoms draw blood and take a urine sample After the study participants will be able to keep the electronic pill bottle cap and Fitbit but will return the smartphone
Detailed Description:
This is an exploratory Phase 2 single site open-label direct-to-family adherence and exposure-response study of hydroxychloroquine HCQ in pediatric systemic lupus The study will measure a participants adherence to HCQ self-administration using an electronic pill bottle cap that records datetime of bottle opening and provides participants with a reminder when a dosage is due andor missed All participants will be provided with the electronic pill bottle cap to use with their regular HCQ prescription at the start of the study For the first 2 weeks of the trial the electronic notifications will be disabled to determine a baseline measure of adherence Within 1 day after Visit 2 the electronic notifications will be turned on for all participants resulting in a series of alerts via electronic pill bottle cap alerts and smartphone push notifications text message andor automated phone calls Participants will continue to receive notifications via the electronic pill bottle cap through Visit 4 Throughout the study participants will undergo a series of blood draws and urinalysis collections and be asked to complete various questionnaires
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?:
False
Is an FDA AA801 Violation?:
None