ReCoUPS: Post-Concussion Patient Reports

March 6, 2024 updated by: Children's Hospital of Philadelphia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia
      • Philadelphia, Pennsylvania, United States, 19104
        • The University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 64 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Streak incentive
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
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.
Experimental: Loss-based incentive
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
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.
Active Comparator: Flat-fee control status quo condition
Subjects will receive the maximum possible compensation at the end of the study regardless of response rate.
Behavioral: Flat-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.
Active Comparator: Flat-Fitbit control status quo condition
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant adherence to completing daily survey
Time Frame: 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.
21 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to recovery
Time Frame: 1 to 21 days
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
Time Frame: 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).
1-21 days
Patient-reported activity vs. objective measures of activity
Time Frame: 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.
1-21 days
Test Way to Health platform
Time Frame: 1-21 days
Test Way to Health as a platform for efficiently randomizing and monitoring patients
1-21 days
Correlation between symptoms and cognitive activity
Time Frame: 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).
1-21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Philadelphia

Collaborators

University of Pennsylvania

Investigators

  • Principal Investigator: Douglas Wiebe, PhD, University of Pennsylvania
  • Principal Investigator: Daniel Corwin, MD, Children's Hospital of Philadelphia
  • Principal Investigator: Christina Master, MD, Children's Hospital of Philadelphia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2019

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

February 5, 2021

Study Registration Dates

First Submitted

July 20, 2020

First Submitted That Met QC Criteria

July 31, 2020

First Posted (Actual)

August 5, 2020

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-013326

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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