ConcussionNCT02626650
Recent Experiences With Concussions
A study testing Symptom elicitiation in people with Concussion, run by University of Pennsylvania.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Concussion
- What is being tested?
- Symptom elicitiation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Collegiate athlete (identified by staff at each cooperating institution)
Who cannot join
- Under age of 18
About this study
Official title: 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.
Read the 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.
- Conditions
- Concussion
- Being tested
- Symptom elicitiation
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symptom elicitiationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Symptom elicitiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of symptoms
Participants are asked to indicate how many symptoms were experienced during their most recent sports season.
Measured: Through survey completion, an average of 12 minutes
Secondary outcomes (6)
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.
Measured: Through survey completion, an average of 12 minutes
Concern about concussions
Using questionnaire, participants rate their concern over having experienced a concussion in the past.
Measured: Through survey completion, an average of 12 minutes
Concern about concussions for health
Using questionnaire, participants rate their concern about the risk concussions present to their health
Measured: Through survey completion, an average of 12 minutes
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
Measured: Through survey completion, an average of 12 minutes
Estimated number of concussions
Using questionnaire, participants estimate the number of concussions they experienced in the most recent sport season and in their life.
Measured: Through survey completion, an average of 12 minutes
Knowledge about concussions
Using questionnaire, participants rate their own knowledge about concussions
Measured: Through survey completion, an average of 12 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConcussionStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Carnegie Mellon University, University of Oklahoma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02626650
- Sponsor's protocol ID
- HS15-334
- Status last verified
- Apr 2017
- First submitted
- 4 Dec 2015
- Last updated
- 7 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recent Experiences and Presentation Format: Study of Concussion Symptom Elicitation
- ClinicalTrials.gov ID
- NCT02626650
- Acronym / sponsor ID
- HS15-334
- Conditions
- Concussion
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Carnegie Mellon University, University of Oklahoma
- Study start
- Dec 2015 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 10 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Check symptoms one has experienced | Active comparator | Other: Symptom elicitiationThis 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. |
| Check symptoms one has not experienced | Experimental | Other: Symptom elicitiationParticipants place a check mark next to each symptom they have NOT experienced in the most recent sports season. |
| Uncheck symptoms one has experienced | Experimental | Other: Symptom elicitiationTo 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. |
| Uncheck symptoms one has not experienced. | Experimental | Other: Symptom elicitiationTo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Collegiate athlete (identified by staff at each cooperating institution)
Key exclusion criteria (1 listed)
- Under age of 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Symptom elicitiationSurvey procedure, people check or uncheck symptoms they have or haven't experienced. We randomly assign participants to only one of these symptom elicitation procedures. | Other | Check symptoms one has experienced, Check symptoms one has not experienced, Uncheck symptoms one has experienced, Uncheck symptoms one has not experienced. |
Primary outcome
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.
6 secondary outcomes
Perceived risk of concussions
Time frame: Through survey completion, an average of 12 minutes
Concern about concussions
Time frame: Through survey completion, an average of 12 minutes
Concern about concussions for health
Time frame: Through survey completion, an average of 12 minutes
Beliefs about responses to concussions
Time frame: Through survey completion, an average of 12 minutes
Estimated number of concussions
Time frame: Through survey completion, an average of 12 minutes
Knowledge about concussions
Time frame: Through survey completion, an average of 12 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
- Individual participant dataSharing planned: No. 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.
Related trials for Concussion
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Rehabilitation Through Virtual Immersion & Integrated Exposure for Mild Traumatic Brain Injury (ReVIVE for mTBI)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Symptom elicitiation in people with Concussion, run by University of Pennsylvania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of symptoms (time frame: Through survey completion, an average of 12 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2017.