Concussion, Mild Clinical Trial
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).
Status | Not yet recruiting |
Enrollment | 200 |
Est. completion date | August 30, 2026 |
Est. primary completion date | June 15, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years to 19 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Florida |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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? | 1 month | |
Primary | 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. | 1 month | |
Secondary | 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. | 1 month |
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