Concussion, MildNCT06212726
RTL Concussion Communication
A study testing InjureFree in people with Concussion, Mild and Post Concussion Symptoms, run by University of Florida.
Trial summary
This study is aimed at improving health outcomes for adolescents who sustain sport and recreation related concussions (SRRC) by enhancing Return to Learn (RTL). The study will conduct a quasi-experimental school-based 2 phase study involving 200 students with SRRC. Read more about this study
- Who is it for?
- Ages 14 to 19 years
- Conditions the study is for
- Concussion, Mild, Post Concussion Symptoms, Cognitive Impairments
- What is being tested?
- InjureFree
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 28 Aug 2024to 30 Aug 2026
- 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 14 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Student: enrolled in Alachua County Public Secondary Schools who are age 14 or older and have sustained a new SRRC and voluntarily enrolled in the OSMI (Orthopaedic Sports Medicine Institute) concussion management program
- Parent: primary point of contact for the assenting student verified through the school
Who cannot join
- Student: Age 13 or younger, Not enrolled in Alachua County Public Schools, Did not sustain SRRC during school year
- Parent: not a verified point of contact for the assenting student
About this study
Official title: Evaluation of Return-to-learn Concussion Management Coordination and Social Determinants of Health on Patient-centered Outcomes
This study is aimed at improving health outcomes for adolescents who sustain sport and recreation related concussions (SRRC) by enhancing Return to Learn (RTL). The study will conduct a quasi-experimental school-based 2 phase study involving 200 students with SRRC. The first phase will be descriptive to evaluate current standards (n=50). Phase 2 will compare students whod receive either standard of care RTL (n=75) or RTL augmented by a communication tool (RTC+; n=75).
Read the detailed description
Up to 3.8 million secondary school students are diagnosed with a sport and recreation related concussion (SRRC) annually in the U.S., which can have a detrimental impact on educational attainment, a social determinant of health (SDOH) that is linked with college admission and graduation, employment, income status and social class. This research will address this significant public health problem by gaining a deeper understanding of the relationships among SRRC and SDOH and examine the impact of concussion management team communication on return to learn (RTL) outcomes for students following an SRRC. This research has significant potential to improve RTL outcomes of secondary school students and may provide evidence to support policy-level changes to reduce disparities in SRRC management, especially among low-resource school districts.
The three research aims of this study will proceed as follows:
Aim 1 will examine the relationships among SDOH, SRRC-related symptoms, and RTL milestones among a diverse population of adolescents and young adult secondary school students following SRRC. This aim will be achieved by enrolling and tracking secondary school students who sustain an SRRC over a 12-month period.
Aim 2 will compare RTL milestones among secondary school students following SRRC who are managed by an interdisciplinary concussion management team that uses standard or care plus a communication tool intervention or only standard of care for the RTL process.
Aim 3 will examine differential RTL outcomes between groups (standard of care plus a communication tool intervention vs. only standard of care) based on SDOH, sex as a biological variable, and pre-injury health status among secondary school students following SRRC.
The study aims to reduce disparities in timely management of SRRC during the process of RTL, achievement of RTL milestones and improvement of SRRC-related symptoms in the context of SDOH.
- Conditions
- Concussion, Mild, Post Concussion Symptoms, Cognitive Impairments, Cognitive Impairments, Mild, Multidisciplinary Care Team, Team Nursing
- Being tested
- InjureFree
- Keywords
- concussion, Post-concussion syndrome, return to learn, return to school, concussion management, multidisciplinary care team, Interdisciplinary team, Implementation science, communication
- Medical subject headings
- Brain Concussion, Post-Concussion Syndrome, Cognitive Dysfunction, Learning Disabilities, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InjureFreeBehavioural
The InjureFree software is a commercialized injury incident management platform for organizations working in sports and athlete care and is focused on providing administrators and caregivers' technology to enhance coordination of care. InjureFree will be utilized to track concussion management and communication following SRRC at Buchholz and Gainesville High Schools. This will not modify the current standard of practice for healthcare delivery, it will only modify the communication between members of the concussion management team
| Study group | Role | What they receive |
|---|---|---|
| InjureFree Concussion Communication Tool | Experimental | During the second phase of this trial, participants assigned to the experimental group (Buchholz and Gainesville High Schools) will receive the current standard of care for return to learn following SRRC with the addition of InjureFree, a wed-based injury tracking and communication tool. InjureFree will serve as a centralized area for concussion management team members to communicate and document participant progress with the return to learn program. Receives: Behavioral: InjureFree |
| Control | No intervention | During the second phase of this trial, participants assigned to the control group (Newberry, Santa Fe and Eastside High Schools) Will not receive any intervention other than the current standard of care for return to learn following SRRC currently in place. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant self-efficacy in concussion symptom management
Participant will demonstrate increased ability in self-management of post-concussion symptoms. To measures self efficacy, the research team will utilize a 10-item scale with answers on a likert scale from 1-10 with 1 being not at all confident and 10 being completely confident. Examples of items are: How confident are you that you can manage your concussion symptoms with the instructions provided by the Concussion Management Team (CMT)? How confident are you that you can manage your return to the classroom with the instructions provided by the CMT? How confident are you that you can judge when the changes in your concussion symptoms means you should visit a doctor? How confident are you that you can exercise without making concussion symptoms worse? How confident are you that you can keep the symptoms of your concussion from interfering with the things you want to do?
Measured: 1 month
Communication satisfaction
Participant will express level of satisfaction with concussion management team (CMT) communication and care delivery throughout the return to learn (RTL) process. RTL communication satisfaction will be measured with a series of questions. The questions will consist of 5 items asking about levels of satisfaction with care coordination, availability of providers and CMT members, education on SRRC provided, understanding of RTL process and frequency of communication from CMT members during RTL. A 4-point Likert scale will be used ranging from not at all satisfied to very satisfied.
Measured: 1 month
Secondary outcomes (1)
Post concussion symptom reduction
Participant will experience a decreased symptom burden as evidenced by scores utilizing the Post-Concussion Symptom Scale (PCSS). The PCSS is a widely used tool for assessing post-concussion symptoms. It measures various physical, cognitive, and emotional symptoms that individuals may experience following a concussion. Participants indicate symptom severity on a scale from 0-6 with zero being no symptoms and six being severe symptoms. Possible scores range from 0 to 132 with higher scores indicating a more severe burden of symptoms.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start28 Aug 2024 (estimated)
- Primary completion15 Jun 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Why it stopped: Investigators left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concussion, MildStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06212726
- Sponsor's protocol ID
- IRB202301378
- Status last verified
- Oct 2024
- First submitted
- 19 Sep 2023
- Last updated
- 23 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IDP will be made available to other researchers upon request. Only de-identified information will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Return-to-learn Concussion Management Coordination and Social Determinants of Health on Patient-centered Outcomes
- ClinicalTrials.gov ID
- NCT06212726
- Acronym / sponsor ID
- IRB202301378
- Conditions
- Concussion, Mild, Post Concussion Symptoms, Cognitive Impairments, Cognitive Impairments, Mild, Multidisciplinary Care Team, Team Nursing
- Keywords
- concussion, Post-concussion syndrome, return to learn, return to school, concussion management, multidisciplinary care team, Interdisciplinary team, Implementation science
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigators left the institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 28 Aug 2024 (estimated)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 19 Jan 2024 (actual)
- 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.
This study is aimed at improving health outcomes for adolescents who sustain sport and recreation related concussions (SRRC) by enhancing Return to Learn (RTL). The study will conduct a quasi-experimental school-based 2 phase study involving 200 students with SRRC. The first phase will be descriptive to evaluate current standards (n=50). Phase 2 will compare students whod receive either standard of care RTL (n=75) or RTL augmented by a communication tool (RTC+; n=75).
Detailed description
Up to 3.8 million secondary school students are diagnosed with a sport and recreation related concussion (SRRC) annually in the U.S., which can have a detrimental impact on educational attainment, a social determinant of health (SDOH) that is linked with college admission and graduation, employment, income status and social class. This research will address this significant public health problem by gaining a deeper understanding of the relationships among SRRC and SDOH and examine the impact of concussion management team communication on return to learn (RTL) outcomes for students following an SRRC. This research has significant potential to improve RTL outcomes of secondary school students and may provide evidence to support policy-level changes to reduce disparities in SRRC management, especially among low-resource school districts.
The three research aims of this study will proceed as follows:
Aim 1 will examine the relationships among SDOH, SRRC-related symptoms, and RTL milestones among a diverse population of adolescents and young adult secondary school students following SRRC. This aim will be achieved by enrolling and tracking secondary school students who sustain an SRRC over a 12-month period.
Aim 2 will compare RTL milestones among secondary school students following SRRC who are managed by an interdisciplinary concussion management team that uses standard or care plus a communication tool intervention or only standard of care for the RTL process.
Aim 3 will examine differential RTL outcomes between groups (standard of care plus a communication tool intervention vs. only standard of care) based on SDOH, sex as a biological variable, and pre-injury health status among secondary school students following SRRC.
The study aims to reduce disparities in timely management of SRRC during the process of RTL, achievement of RTL milestones and improvement of SRRC-related symptoms in the context of SDOH.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| InjureFree Concussion Communication Tool | Experimental | Behavioral: InjureFreeDuring the second phase of this trial, participants assigned to the experimental group (Buchholz and Gainesville High Schools) will receive the current standard of care for return to learn following SRRC with the addition of InjureFree, a wed-based injury tracking and communication tool. InjureFree will serve as a centralized area for concussion management team members to communicate and document participant progress with the return to learn program. |
| Control | No intervention | –During the second phase of this trial, participants assigned to the control group (Newberry, Santa Fe and Eastside High Schools) Will not receive any intervention other than the current standard of care for return to learn following SRRC currently in place. |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Student: enrolled in Alachua County Public Secondary Schools who are age 14 or older and have sustained a new SRRC and voluntarily enrolled in the OSMI (Orthopaedic Sports Medicine Institute) concussion management program
- Parent: primary point of contact for the assenting student verified through the school
Key exclusion criteria (2 listed)
- Student: Age 13 or younger, Not enrolled in Alachua County Public Schools, Did not sustain SRRC during school year
- Parent: not a verified point of contact for the assenting student
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 |
|---|---|---|
| InjureFreeThe InjureFree software is a commercialized injury incident management platform for organizations working in sports and athlete care and is focused on providing administrators and caregivers' technology to enhance coordination of care. InjureFree will be utilized to track concussion management and communication following SRRC at Buchholz and Gainesville High Schools. This will not modify the current standard of practice for healthcare delivery, it will only modify the communication between members of the concussion management team | Behavioural | InjureFree Concussion Communication Tool |
Primary outcome
Participant self-efficacy in concussion symptom management
Time frame: 1 month
Participant will demonstrate increased ability in self-management of post-concussion symptoms. To measures self efficacy, the research team will utilize a 10-item scale with answers on a likert scale from 1-10 with 1 being not at all confident and 10 being completely confident. Examples of items are: How confident are you that you can manage your concussion symptoms with the instructions provided by the Concussion Management Team (CMT)? How confident are you that you can manage your return to the classroom with the instructions provided by the CMT? How confident are you that you can judge when the changes in your concussion symptoms means you should visit a doctor? How confident are you that you can exercise without making concussion symptoms worse? How confident are you that you can keep the symptoms of your concussion from interfering with the things you want to do?
Communication satisfaction
Time frame: 1 month
Participant will express level of satisfaction with concussion management team (CMT) communication and care delivery throughout the return to learn (RTL) process. RTL communication satisfaction will be measured with a series of questions. The questions will consist of 5 items asking about levels of satisfaction with care coordination, availability of providers and CMT members, education on SRRC provided, understanding of RTL process and frequency of communication from CMT members during RTL. A 4-point Likert scale will be used ranging from not at all satisfied to very satisfied.
1 secondary outcome
Post concussion symptom reduction
Time frame: 1 month
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 23 Oct 2024.
- Individual participant dataSharing planned: No. IDP will be made available to other researchers upon request. Only de-identified information will be made available.
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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 InjureFree in people with Concussion, Mild and Post Concussion Symptoms, run by University of Florida.
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 2 inclusion and 2 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 23 Oct 2024. 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?
Participant self-efficacy in concussion symptom management (time frame: 1 month). The study lists 2 primary outcomes in all. 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 23 Oct 2024.