ReCoUPS: Post-Concussion Patient Reports

NCT04499937 | Completed

• 1 other identifier: 16-013326
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Brain Concussion; Head Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Time to recovery

  1 to 21 days

• Correlation between symptoms and physical activity

  1-21 days

• Patient-reported activity vs. objective measures of activity

  1-21 days

• Test Way to Health platform

  1-21 days

• Correlation between symptoms and cognitive activity

  1-21 days

Study Arms (4)

Streak incentive

EXPERIMENTAL

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

Loss-based incentive

EXPERIMENTAL

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

Flat-fee control status quo condition

ACTIVE COMPARATOR

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

Behavioral: Flat-fee control status quo condition

Flat-Fitbit control status quo condition

ACTIVE COMPARATOR

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

Interventions

Streak incentive BEHAVIORAL

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.

Streak incentive

Loss-based incentive BEHAVIORAL

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.

Loss-based incentive

Flat-fee control status quo condition BEHAVIORAL

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.

Flat-fee control status quo condition

Flat-Fitbit control status quo condition BEHAVIORAL

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.

Flat-Fitbit control status quo condition

Eligibility Criteria

• Age: 13 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• University of Pennsylvania: collaborator

Study Sites (2)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

The University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (11)

• Korley FK, Kelen GD, Jones CM, Diaz-Arrastia R. Emergency Department Evaluation of Traumatic Brain Injury in the United States, 2009-2010. J Head Trauma Rehabil. 2016 Nov/Dec;31(6):379-387. doi: 10.1097/HTR.0000000000000187.

  PMID: 26360006 BACKGROUND

• McCrea M, Guskiewicz KM, Marshall SW, Barr W, Randolph C, Cantu RC, Onate JA, Yang J, Kelly JP. Acute effects and recovery time following concussion in collegiate football players: the NCAA Concussion Study. JAMA. 2003 Nov 19;290(19):2556-63. doi: 10.1001/jama.290.19.2556.

  PMID: 14625332 BACKGROUND

• Leddy JJ, Baker JG, Kozlowski K, Bisson L, Willer B. Reliability of a graded exercise test for assessing recovery from concussion. Clin J Sport Med. 2011 Mar;21(2):89-94. doi: 10.1097/JSM.0b013e3181fdc721.

  PMID: 21358497 BACKGROUND

• Brown NJ, Mannix RC, O'Brien MJ, Gostine D, Collins MW, Meehan WP 3rd. Effect of cognitive activity level on duration of post-concussion symptoms. Pediatrics. 2014 Feb;133(2):e299-304. doi: 10.1542/peds.2013-2125. Epub 2014 Jan 6.

  PMID: 24394679 BACKGROUND

• McCrory P, Meeuwisse WH, Aubry M, Cantu B, Dvorak J, Echemendia RJ, Engebretsen L, Johnston K, Kutcher JS, Raftery M, Sills A, Benson BW, Davis GA, Ellenbogen RG, Guskiewicz K, Herring SA, Iverson GL, Jordan BD, Kissick J, McCrea M, McIntosh AS, Maddocks D, Makdissi M, Purcell L, Putukian M, Schneider K, Tator CH, Turner M. Consensus statement on concussion in sport: the 4th International Conference on Concussion in Sport held in Zurich, November 2012. Br J Sports Med. 2013 Apr;47(5):250-8. doi: 10.1136/bjsports-2013-092313. No abstract available.

  PMID: 23479479 BACKGROUND

• Moor HM, Eisenhauer RC, Killian KD, Proudfoot N, Henriques AA, Congeni JA, Reneker JC. The relationship between adherence behaviors and recovery time in adolescents after a sports-related concussion: an observational study. Int J Sports Phys Ther. 2015 Apr;10(2):225-33.

  PMID: 25883871 BACKGROUND

• Meehan WP 3rd, Bachur RG. The recommendation for rest following acute concussion. Pediatrics. 2015 Feb;135(2):362-3. doi: 10.1542/peds.2014-3665. Epub 2015 Jan 5. No abstract available.

  PMID: 25560439 BACKGROUND

• Thomas DG, Apps JN, Hoffmann RG, McCrea M, Hammeke T. Benefits of strict rest after acute concussion: a randomized controlled trial. Pediatrics. 2015 Feb;135(2):213-23. doi: 10.1542/peds.2014-0966. Epub 2015 Jan 5.

  PMID: 25560444 BACKGROUND

• Schneider KJ, Iverson GL, Emery CA, McCrory P, Herring SA, Meeuwisse WH. The effects of rest and treatment following sport-related concussion: a systematic review of the literature. Br J Sports Med. 2013 Apr;47(5):304-7. doi: 10.1136/bjsports-2013-092190.

  PMID: 23479489 BACKGROUND

• Wiebe DJ, Nance ML, Houseknecht E, Grady MF, Otto N, Sandsmark DK, Master CL. Ecologic Momentary Assessment to Accomplish Real-Time Capture of Symptom Progression and the Physical and Cognitive Activities of Patients Daily Following Concussion. JAMA Pediatr. 2016 Nov 1;170(11):1108-1110. doi: 10.1001/jamapediatrics.2016.1979. No abstract available.

  PMID: 27617669 BACKGROUND

• Corwin DJ, Orchinik J, D'Alonzo B, Agarwal AK, Pettijohn KW, Master CL, Wiebe DJ. A Randomized Trial of Incentivization to Maximize Retention for Real-Time Symptom and Activity Monitoring Using Ecological Momentary Assessment in Pediatric Concussion. Pediatr Emerg Care. 2023 Jul 1;39(7):488-494. doi: 10.1097/PEC.0000000000002870. Epub 2022 Nov 3.

  PMID: 36730797 DERIVED

MeSH Terms

Conditions

Brain Concussion; Craniocerebral Trauma

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2020
• First Posted: August 5, 2020
• Study Start: March 3, 2019
• Primary Completion: December 31, 2020
• Study Completion: February 5, 2021
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)