- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02626650
Recent Experiences With Concussions
Recent Experiences and Presentation Format: Study of Concussion Symptom Elicitation
Study Overview
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
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Collegiate athlete (identified by staff at each cooperating institution)
Exclusion Criteria:
- Under age of 18
Study Plan
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
IPD Plan Description
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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