NCT04499937

ReCoUPS: Post-Concussion Patient Reports

ReCoUPS: Incentive-Based and Real-Time Symptom and Activity Reporting After Concussion

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Children's Hospital of Philadelphia · Academic / Other
• Sex: All
• Age: 13 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Brain Concussion
• Head Injury

Interventions

Type	Name	Description
BEHAVIORAL	Streak incentive	Participants will receive prompts 3 times a day for 21 days prompting them to complete surveys. They will start with a $0 balance and will earn a fixed amount for each response.
BEHAVIORAL	Loss-based incentive	Participants will receive prompts 3 times a day for 21 days prompting them to complete surveys. They will start with the maximum balance and will lose a fixed amount for each response they do not complete.
BEHAVIORAL	Flat-fee control status quo condition	Participants will receive prompts 3 times a day for 21 days prompting them to complete surveys. They will receive the maximum compensation at the end of the study.
BEHAVIORAL	Flat-Fitbit control status quo condition	Participants will receive prompts 3 times a day for 21 days prompting them to complete surveys. They will keep the Fitbit at the end of the study.

Timeline

• Start date: 2019-03-03
• Primary completion: 2020-12-31
• Completion: 2021-02-05
• First posted: 2020-08-05
• Last updated: 2024-03-08

Locations

2 sites across 1 country: United States