ReCoUPS: Post-Concussion Patient Reports

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Brain Concussion, Head Injury

Intervention / Treatment
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* Behavioral: Streak incentive
* Behavioral: Loss-based incentive
* Behavioral: Flat-fee control status quo condition
* Behavioral: Flat-Fitbit control status quo condition


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Streak incentive<br>Subjects start with no money in an account, but they earn a fixed amount with each response. In this arm, each adult report is worth $3.17 so an adult subject can earn up to $200 if he/she responds to all surveys. If an adult completes at least 75% of the reports, he/she will receive an $100 bonus for a total maximum of $300. In this arm, each child report is worth 0.52 cents so a child subject can earn up to $33 if he/she responds to all surveys. If a child completes at least 75% of the reports, he/she will receive a $17 bonus for a total maximum of $50. | Behavioral: Streak incentive<br>* 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.<br>|
| Experimental: Loss-based incentive<br>Subjects start with the maximum possible compensation, but money is deducted for each missed response. Adult subjects will lose $4.76 for each missed survey. Child subjects will lose $0.79 for each missed survey. | Behavioral: Loss-based incentive<br>* 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.<br>|
| Active Comparator: Flat-fee control status quo condition<br>Subjects will receive the maximum possible compensation at the end of the study regardless of response rate. | Behavioral: Flat-fee control status quo condition<br>* 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.<br>|
| Active Comparator: Flat-Fitbit control status quo condition<br>Subjects will be compensated by keeping the Fitbit at the end of the study regardless of response rate. | Behavioral: Flat-Fitbit control status quo condition<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to recovery | Assess and quantify the concussion recovery process by monitoring symptoms and cognitive and physical activity on a daily basis. | 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). | 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. | 1-21 days | 
| Test Way to Health platform | Test Way to Health as a platform for efficiently randomizing and monitoring patients | 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). | 1-21 days |