ReCoUPS: Post-Concussion Patient Reports

Not Applicable

Completed

• Conditions: Brain Concussion; Head Injury

• Registration Number: NCT04499937
• Lead Sponsor: Children's Hospital of Philadelphia

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 Timeline

• Study Start: 2019-03-03
• Study First Submitted: 2020-07-20
• Study First Submitted QC: 2020-07-31
• Study First Posted: 2020-08-05
• Primary Completion: 2020-12-31
• Study Completion: 2021-02-05
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-06
• Last Update Posted: 2024-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Males or females ages 13 to 64 years.
• Presents with head injury concerning for concussion in line with criteria specified in the most recent Consensus Statement on Concussion in Sport, defined as head trauma with neurologic impairment, including, but not limited to somatic (eg, headache), cognitive (eg, feeling like in a fog) and/or emotional symptoms (eg, lability) symptoms.
• Within approximately 5 days of injury.
• Ownership of a smartphone to report symptoms and activities.
• Speak English.
• Informed consent or parental/guardian permission and child assent for those under 18 years of age.

Exclusion Criteria

• Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Participant adherence to completing daily survey	21 days	This is a study where each participant is sent a short survey (PCSI instrument) three times each day for 21 days. The participant is instructed to reply to each survey within several minutes of receiving the prompt. We are interested in the extent to which participants will adhere to this instruction. Therefore, the outcome of interest is whether or not the participant replied to a given survey prompt. When we evaluate patient adherence in the data, we do this by calculating the % of survey prompts to which a given participant responded. In sum, the outcome is adherence to the survey.

Secondary Outcome Measures

Name	Time	Method
Time to recovery	1 to 21 days	Assess and quantify the concussion recovery process by monitoring symptoms and cognitive and physical activity on a daily basis.
Test Way to Health platform	1-21 days	Test Way to Health as a platform for efficiently randomizing and monitoring patients
Correlation between symptoms and cognitive activity	1-21 days	Determine if there is a correlation each day between the daily symptom score from the PCSI (0-126) and the number of hours participants spent doing homework, napping, and using screens combined (cognitive activity).
Patient-reported activity vs. objective measures of activity	1-21 days	Compare the patient-reported hours spent exercising on a given day to the patient's daily step count collected through Fitbit on that same day.
Correlation between symptoms and physical activity	1-21 days	Determine if there is a correlation each day between the daily symptom score from the PCSI (0-126) and the number of hours spent exercising (physical activity).

Trial Locations

Locations (2)

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

The University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States