Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2026-01-01 @ 2:46 AM
Study NCT ID:
NCT07128706
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-08-19
First Post:
2025-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Harmonization and Implementation of Sports-related Concussion Guidelines in European Football for Youth - the Erasmus + Project
Sponsor:
Acibadem University
Organization:
Study Overview
Official Title:
Harmonization and Implementation of Sports-related Concussion Guidelines in European Football for Youth - the REFORM Erasmus + Project
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REFORM
Brief Summary:
This study addresses the evident gap in SRC awareness and reporting, especially at the grassroots level, by harmonizing concussion management practices across Europe and observing its impact on stakeholders' (coaches, parents, players, referees) knowledge and practices.
Detailed Description:
This project is a multi-phase observational study using a participatory action research design. It includes the identification, documentation, and evaluation of educational tools to improve concussion management practices in European youth football. Each phase of the study is guided by the Logical Framework Approach (LFA) to ensure systematic evaluation and measurable outcomes.
The project adopts a stakeholder-centered methodology, involving key stakeholders, including football associations, healthcare professionals, and academia, from Norway, Germany, Croatia, and Türkiye. This structured approach ensures that each phase aligns with specific objectives, outputs, and outcomes, enhancing the project's coherence and impact. The LFA was chosen for its structured, outcome-oriented methodology, which aligns well with the goals of this multi-phase, transnational project. LFA facilitates clear goal-setting, stakeholder engagement, and systematic monitoring, ensuring alignment between the project's objectives and measurable outcomes. Compared to other participatory research approaches, LFA's emphasis on stakeholder-driven planning ensures that the developed educational tools are practical, culturally relevant, and widely applicable across diverse European football contexts.
The project will use a stakeholder approach to collaboratively observe, assess, and document innovative educational materials and resources for concussion awareness that emerging in routine practice. This process will be interdisciplinary and transnational, ensuring that the materials are harmonized and build upon each other to meet the needs of various stakeholders. The project will use surveys to articulate training and educational standards to ensure a high-quality standard that can be scaled across European national football associations down to grassroots levels in each country.
Through a participatory process, the project will solicit expert opinion and keep an ongoing dialogue with multiple facets of stakeholders to guarantee an evidence-based joint European educational awareness set that meets the demands of the coaches and board, as well as fostering an awareness in the players and their families.
Setting and Participants The project will be conducted in collaboration with football associations from Norway, Germany, Croatia, and Türkiye. Participants will include selected football clubs from these countries, chosen to represent diverse cultural and operational contexts.
To ensure the educational materials are effective across the diverse cultural contexts of the participating countries, the project will implement a robust process of cultural adaptation. This will involve the translation of educational materials into the native languages of each participating country, ensuring accuracy and clarity in communication. UEFA-approved translators will be used to maintain the integrity of the content.
Additionally, local experts, football stakeholders, and national football federations will play an active role in providing culturally specific insights throughout the development phase. This collaborative approach ensures that the content resonates with the distinct cultural contexts, communication styles, and practices of each country. Focus group discussions and pilot testing will be conducted in each country to refine the materials further, ensuring their relevance and effectiveness in addressing regional nuances related to concussion management.
The dissemination phase employs a multi-channel strategy, combining direct stakeholder engagement with digital tools and institutional partnerships to reach diverse audiences across Europe. Resources will be shared with national football associations for scaling across Europe, leveraging social media platforms to enhance outreach. The findings of this project will be analyzed and published in peer-reviewed journals, as well as presented at key conferences. All findings will be disseminated to accurately inform future practices. This will occur immediately after the completion of the final analysis.
The project adopts a stakeholder-centered methodology, involving key stakeholders, including football associations, healthcare professionals, and academia, from Norway, Germany, Croatia, and Türkiye. This structured approach ensures that each phase aligns with specific objectives, outputs, and outcomes, enhancing the project's coherence and impact. The LFA was chosen for its structured, outcome-oriented methodology, which aligns well with the goals of this multi-phase, transnational project. LFA facilitates clear goal-setting, stakeholder engagement, and systematic monitoring, ensuring alignment between the project's objectives and measurable outcomes. Compared to other participatory research approaches, LFA's emphasis on stakeholder-driven planning ensures that the developed educational tools are practical, culturally relevant, and widely applicable across diverse European football contexts.
The project will use a stakeholder approach to collaboratively observe, assess, and document innovative educational materials and resources for concussion awareness that emerging in routine practice. This process will be interdisciplinary and transnational, ensuring that the materials are harmonized and build upon each other to meet the needs of various stakeholders. The project will use surveys to articulate training and educational standards to ensure a high-quality standard that can be scaled across European national football associations down to grassroots levels in each country.
Through a participatory process, the project will solicit expert opinion and keep an ongoing dialogue with multiple facets of stakeholders to guarantee an evidence-based joint European educational awareness set that meets the demands of the coaches and board, as well as fostering an awareness in the players and their families.
Setting and Participants The project will be conducted in collaboration with football associations from Norway, Germany, Croatia, and Türkiye. Participants will include selected football clubs from these countries, chosen to represent diverse cultural and operational contexts.
To ensure the educational materials are effective across the diverse cultural contexts of the participating countries, the project will implement a robust process of cultural adaptation. This will involve the translation of educational materials into the native languages of each participating country, ensuring accuracy and clarity in communication. UEFA-approved translators will be used to maintain the integrity of the content.
Additionally, local experts, football stakeholders, and national football federations will play an active role in providing culturally specific insights throughout the development phase. This collaborative approach ensures that the content resonates with the distinct cultural contexts, communication styles, and practices of each country. Focus group discussions and pilot testing will be conducted in each country to refine the materials further, ensuring their relevance and effectiveness in addressing regional nuances related to concussion management.
The dissemination phase employs a multi-channel strategy, combining direct stakeholder engagement with digital tools and institutional partnerships to reach diverse audiences across Europe. Resources will be shared with national football associations for scaling across Europe, leveraging social media platforms to enhance outreach. The findings of this project will be analyzed and published in peer-reviewed journals, as well as presented at key conferences. All findings will be disseminated to accurately inform future practices. This will occur immediately after the completion of the final analysis.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: