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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
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.
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.
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
The University of Pennsylvania
Philadelphia, Pennsylvania, United States
Participant adherence to completing daily survey
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.
Time frame: 21 days
Time to recovery
Assess and quantify the concussion recovery process by monitoring symptoms and cognitive and physical activity on a daily basis.
Time frame: 1 to 21 days
Correlation between symptoms and physical activity
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).
Time frame: 1-21 days
Patient-reported activity vs. objective measures of activity
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.
Time frame: 1-21 days
Test Way to Health platform
Test Way to Health as a platform for efficiently randomizing and monitoring patients
Time frame: 1-21 days
Correlation between symptoms and cognitive activity
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).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: 1-21 days