Brain Concussion, Head Injury
Conditions
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.
Interventions
BEHAVIORALStreak 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.
BEHAVIORALLoss-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.
BEHAVIORALFlat-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.
BEHAVIORALFlat-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.
Sponsors
University of Pennsylvania
Children's Hospital of Philadelphia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 64 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
| 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. |
| 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). |
Countries
United States
Outcome results
None listed