Ignite Creation Date:
2024-05-06 @ 3:00 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04499937
Status:
COMPLETED
Last Update Posted:
2024-03-08
First Post:
2020-07-20
Brief Title:
ReCoUPS Post-Concussion Patient Reports
Sponsor:
Childrens Hospital of Philadelphia
Organization:
Childrens Hospital of Philadelphia
Study Overview
Official Title:
ReCoUPS Incentive-Based and Real-Time Symptom and Activity Reporting After Concussion
Status:
COMPLETED
Status Verified Date:
2024-03
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:
Physical and cognitive rest are recommended as treatment for concussion but debate persists about the utility of this recommendation for patients recovering from concussion In addition patient adherence to physical and cognitive rest recommendations after concussion remains unknown This study will measure and compare symptom and activity reports in the days and weeks after a concussion among patients randomly assigned to different incentive-based arms
Detailed Description:
Although physical and cognitive rest are recommended as the hallmark treatment for concussion debate persists about the utility of this recommendation for patients recovering from a concussion In addition patient adherence to physical and cognitive rest recommendations after concussion remains unknown Objective and timely measures of physical and cognitive activity will aid in defining the relationship between physical and cognitive rest and clinical outcomes such as symptom status in the days and weeks after a concussion Random assignment to incentive-based arms will be used to measure patient engagement with the study protocol and a dedicated research platform that involves ecological momentary assessment EMA in which participants report their real-time symptoms and daily activities in response to randomly timed prompts will be used to help assess the rest and recovery process among pediatric and adult patients after concussion
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