Recent Experiences With Concussions

Concussion Clinical Trial

Official title:

Recent Experiences and Presentation Format: Study of Concussion Symptom Elicitation

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02626650
• Other study ID #: HS15-334
• Status: Withdrawn
• Phase: N/A
• First received: December 4, 2015
• Last updated: April 5, 2017
• Start date: December 2015
• Est. completion date: November 2016

Study information

• Verified date: April 2017
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Under age of 18

Related Conditions & MeSH terms

• Concussion

Intervention

Other:
• Symptom elicitiation
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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Pennsylvania	Carnegie Mellon University, University of Oklahoma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Perceived risk of concussions	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
Secondary	Concern about concussions	Using questionnaire, participants rate their concern over having experienced a concussion in the past.	Through survey completion, an average of 12 minutes
Secondary	Concern about concussions for health	Using questionnaire, participants rate their concern about the risk concussions present to their health	Through survey completion, an average of 12 minutes
Secondary	Beliefs about responses to concussions	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
Secondary	Estimated number of concussions	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
Secondary	Knowledge about concussions	Using questionnaire, participants rate their own knowledge about concussions	Through survey completion, an average of 12 minutes