NCT02626650

Brief Summary

College athletes will be recruited to complete a voluntary online survey that will take approximately 10 minutes. In this survey, they will answer a series of questions related to the concussion symptoms they have experienced in their recent sports season, their opinions related to concussions and concussion treatment, and demographics.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2015

Status
withdrawn

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

Study Start

First participant enrolled

December 1, 2015

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 10, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

April 7, 2017

Status Verified

April 1, 2017

Enrollment Period

11 months

First QC Date

December 4, 2015

Last Update Submit

April 5, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of symptoms

    Participants are asked to indicate how many symptoms were experienced during their most recent sports season.

    Through survey completion, an average of 12 minutes

Secondary Outcomes (6)

  • Perceived risk of concussions

    Through survey completion, an average of 12 minutes

  • Concern about concussions

    Through survey completion, an average of 12 minutes

  • Concern about concussions for health

    Through survey completion, an average of 12 minutes

  • Beliefs about responses to concussions

    Through survey completion, an average of 12 minutes

  • Estimated number of concussions

    Through survey completion, an average of 12 minutes

  • +1 more secondary outcomes

Study Arms (4)

Check symptoms one has experienced

ACTIVE COMPARATOR

This is the baseline condition. When asked to indicate concussion symptoms (or most other kinds of symptoms for medical conditions), people usually place a check mark next to each symptom they have experienced.

Other: Symptom elicitiation

Check symptoms one has not experienced

EXPERIMENTAL

Participants place a check mark next to each symptom they have NOT experienced in the most recent sports season.

Other: Symptom elicitiation

Uncheck symptoms one has experienced

EXPERIMENTAL

To begin, all symptoms will be automatically checked. Participants are told to remove a check mark from each symptom they have experienced in the most recent sports season.

Other: Symptom elicitiation

Uncheck symptoms one has not experienced.

EXPERIMENTAL

To begin, all symptoms will be automatically checked. Participants are told to remove a check mark from each symptom they have NOT experienced in the most recent sports season.

Other: Symptom elicitiation

Interventions

Survey procedure, people check or uncheck symptoms they have or haven't experienced. We randomly assign participants to only one of these symptom elicitation procedures.

Check symptoms one has experiencedCheck symptoms one has not experiencedUncheck symptoms one has experiencedUncheck symptoms one has not experienced.

Eligibility Criteria

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

You may qualify if:

  • Collegiate athlete (identified by staff at each cooperating institution)

You may not qualify if:

  • Under age of 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2015

First Posted

December 10, 2015

Study Start

December 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

April 7, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Data will be analyzed by the research team and reported only in aggregate, so individual participant data will not be shared or made publicly available.