Recent Experiences With Concussions

April 5, 2017 updated by: University of Pennsylvania

Recent Experiences and Presentation Format: Study of Concussion Symptom Elicitation

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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.

Of interest, participants will indicate what concussion symptoms they have recently experienced in one of four formats, to which they will be randomly assigned. Participants will either *check the symptoms they have experienced, *check the symptoms they have not experienced, *uncheck the symptoms they have experienced, or *uncheck the symptoms they have not experienced. It is believed that an alternative method of reporting symptoms that requires participants to indicate the symptoms they have not experienced will lead them to report having experienced a greater number of symptoms, based on past research regarding inclusion vs. exclusion modes of thought.

Study Type

Interventional

Phase

  • Not Applicable

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Under age of 18

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Check symptoms one has experienced
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.
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.
Experimental: Check symptoms one has not experienced
Participants place a check mark next to each symptom they have NOT experienced in the most recent sports season.
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.
Experimental: Uncheck symptoms one has experienced
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.
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.
Experimental: Uncheck symptoms one has not experienced.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of symptoms
Time Frame: Through survey completion, an average of 12 minutes
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived risk of concussions
Time Frame: Through survey completion, an average of 12 minutes
Using questionnaire, participants rate their perceived risk of having a concussion compared to the average American and the average college athlete over the next year.
Through survey completion, an average of 12 minutes
Concern about concussions
Time Frame: Through survey completion, an average of 12 minutes
Using questionnaire, participants rate their concern over having experienced a concussion in the past.
Through survey completion, an average of 12 minutes
Concern about concussions for health
Time Frame: Through survey completion, an average of 12 minutes
Using questionnaire, participants rate their concern about the risk concussions present to their health
Through survey completion, an average of 12 minutes
Beliefs about responses to concussions
Time Frame: Through survey completion, an average of 12 minutes
Using questionnaire, participants rate the extent to which they think others are concerned about concussions and should respond to concussions
Through survey completion, an average of 12 minutes
Estimated number of concussions
Time Frame: Through survey completion, an average of 12 minutes
Using questionnaire, participants estimate the number of concussions they experienced in the most recent sport season and in their life.
Through survey completion, an average of 12 minutes
Knowledge about concussions
Time Frame: Through survey completion, an average of 12 minutes
Using questionnaire, participants rate their own knowledge about concussions
Through survey completion, an average of 12 minutes

Collaborators and Investigators

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

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)

December 1, 2015

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

December 4, 2015

First Submitted That Met QC Criteria

December 8, 2015

First Posted (Estimate)

December 10, 2015

Study Record Updates

Last Update Posted (Actual)

April 7, 2017

Last Update Submitted That Met QC Criteria

April 5, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • HS15-334

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

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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