ReCoUPS: Post-Concussion Patient Reports

Brain Concussion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04499937
• Other study ID #: 16-013326
• Status: Completed
• Phase: N/A
• Start date: March 3, 2019
• Est. completion date: February 5, 2021

Study information

• Verified date: March 2024
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 5, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Concussion
• Craniocerebral Trauma
• Head Injury

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	The University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Test Way to Health platform	Test Way to Health as a platform for efficiently randomizing and monitoring patients	1-21 days
Secondary	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