ReCoUPS: Post-Concussion Patient Reports

Children's Hospital of Philadelphia (CHOP)

Status

Completed

Conditions

Head Injury

Brain Concussion

Treatments

Behavioral: Flat-fee control status quo condition

Behavioral: Streak incentive

Behavioral: Flat-Fitbit control status quo condition

Behavioral: Loss-based incentive

Study type

Interventional

Funder types

Other

Identifiers

NCT04499937

16-013326

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

13 to 64 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 4 patient groups

Streak incentive

Experimental group

Description:

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.

Treatment:

Behavioral: Streak incentive

Loss-based incentive

Experimental group

Description:

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.

Treatment:

Behavioral: Loss-based incentive

Flat-fee control status quo condition

Active Comparator group

Description:

Subjects will receive the maximum possible compensation at the end of the study regardless of response rate.

Treatment:

Behavioral: Flat-fee control status quo condition

Flat-Fitbit control status quo condition

Active Comparator group

Description:

Subjects will be compensated by keeping the Fitbit at the end of the study regardless of response rate.