NCT05836662

Brief Summary

The purpose of this study is to determine if there are differences in knowledge, self-efficacy, and empathy surrounding concussions, as well as intent to report a concussion, after viewing concussion education (CrashCourse and Brain Fly-Through) in 2D versus in 3D. In this randomized study, all participants will receive two types of concussion education (CrashCourse and Brain Fly-Through). Participants will be randomized to the 2D or 3D (Virtual Reality) group, and will experience both concussion educations in that modality (either 2D or 3D).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

April 19, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 1, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

1.3 years

First QC Date

April 19, 2023

Last Update Submit

November 20, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in the participant's knowledge, self-efficacy, and empathy surrounding concussions

    Participants will take a pre-survey (prior to receiving the concussion education), an immediate post-survey (right after completion of the concussion education), and two-month post-survey (two months after the concussion education. These surveys will assess participant's knowledge, self-efficacy, and empathy surrounding concussions.

    2 months

Study Arms (2)

2D Concussion Education

ACTIVE COMPARATOR

During their in person study visit, participants will complete a brief ( \~5 minute) pre-survey before viewing the CrashCourse and Brain Fly-Through concussion educations. Participants in this group will receive both of these educations in 2D (via a video on a laptop). Participants will then be asked to complete a brief ( \~2 minute) survey to assess their knowledge, self-efficacy, and empathy surrounding concussions.

Other: CrashCourse Concussion Education in Virtual Reality

3D Concussion Education

EXPERIMENTAL

During their in person study visit, participants will complete a brief ( \~5 minute) pre-survey before viewing the CrashCourse and Brain Fly-Through concussion educations. Participants in this group will receive both of these educations in 3D (via a Virtual Reality headset). Participants will then be asked to complete a brief ( \~2 minute) survey to assess their knowledge, self-efficacy, and empathy surrounding concussions.

Other: CrashCourse Concussion Education in Virtual Reality

Interventions

The TeachAids concussion education, including CrashCourse and Brain Fly-Through, will be shown in 3D (via a Virtual Reality headset). These educations are the exact same content as the 2D versions viewed on a laptop, but the modality (via a VR headset) is different.

2D Concussion Education3D Concussion Education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • at least 18 years of age
  • health professions student (ex: Nursing, PT, OT, Pharmacy, Athletic Training) and/or a student-athlete at Concordia University (Ann Arbor or Mequon campus)

You may not qualify if:

  • \- have previously viewed the TeachAids CrashCourse concussion education

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Concordia University

Mequon, Wisconsin, 53097, United States

RECRUITING

MeSH Terms

Conditions

Brain ConcussionBehavior

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Study Officials

  • Daniel H Daneshvar, MD, PhD

    TeachAids and Mass General Brigham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel H Daneshvar, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: In this randomized study, all participants will receive two types of concussion education (CrashCourse and Brain Fly-Through). Participants will be randomized to the 2D or 3D (Virtual Reality) group, and will experience both concussion educations in that modality (either 2D or 3D). During their in person study visit, participants will complete a brief ( \~5 minute) pre-survey before viewing the CrashCourse and Brain Fly-Through concussion educations. Participants will then be asked to complete a brief ( \~2 minute) survey to assess their knowledge, self-efficacy, and empathy surrounding concussions. Two months later, participants will receive a brief ( \~5 minute) follow-up survey via email, assessing the same constructs.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Founder & CEO

Study Record Dates

First Submitted

April 19, 2023

First Posted

May 1, 2023

Study Start

April 19, 2023

Primary Completion

July 31, 2024

Study Completion

July 31, 2024

Last Updated

November 22, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations