Making Football Safer for Women: Implementing an Injury Prevention Program

NCT04856241 | Unknown

• 1 other identifier: P2P NHMRC 1193733
• Study Type: interventional
• Target: 2,600
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine how we can best support coaches to implement an injury prevention (IP) program (Prep-to-Play) in female community Australian Football. We will recruit at least 140 female community football teams from 15 different football leagues in Victoria, Australia. Teams will be competing in U16, U17, U18, U19 or open womens competitions. We will train and support coaches to implement the IP program and evaluate the effects of the IP program on injuries across two football seasons.

Conditions

Anterior Cruciate Ligament Injuries; Concussion, Brain; Musculoskeletal Injury

Keywords

injury prevention; implementation; football; female

Outcome Measures

Primary Outcomes (1)

• Use of Prep-to-Play (Primary outcome)

  Use of Prep-to-Play will be calculated as the proportion of all possible team sessions (training and games) where Prep-to-Play essential components were completed. The primary outcome assessor will be the Team Designate (i.e., nominated team manager, or team representative) who will record (via the Smartabase App or website) whether essential components of Prep-to-Play were completed at each training session and games. In addition to the Team Designate, Prep-to-Play Observers (research assistants blinded to randomisation) will make five random visits (≥one prior to the intervention period and ≥two after the intervention period) to observe the execution of Prep-to-Play in order to validate team use data from the Team Designates.

  18 months

Secondary Outcomes (4)

• Number of players with an ACL injury (Secondary outcome)

  18 months

• Number of players with a concussion (Secondary outcome)

  18 months

• Number of player hours (training and match)

  18 months

• Healthcare utilisation

  18 months

Study Arms (2)

Supported Implementation (Intervention)

EXPERIMENTAL

Our supported implementation approach is designed to improve uptake of Prep-to-Play. The Prep-to-Play program consists of four components: dynamic warm-up, strength training, football fundamentals, and education. At the start of the intervention period, Prep-to-Play Physiotherapists will conduct a 3-hour workshop for coaches and influential players. Ongoing support will be provided via a range of strategies. Prep-to-Play Physiotherapists will attend training (two times) during and immediately post implementation to provide coaches with support (feedback on missing components, player technique, questions). Monthly Coaches Shed; Online drop-in session with education component to meet other coaches (peer support \& networking) and ask questions. Refresher workshops will be run in pre-season 2022 for the teams who have received the intervention in 2021.

Other: Coaching; Other: Peer support; Other: Educational materials

Unsupported implementation (Control)

ACTIVE COMPARATOR

The unsupported implementation arm will be "usual care". Access to the Prep-to-Play resources, including videos, downloadable manuals and posters, are freely available to coaches online. The online resources incorporate the same four concepts as described in the supported implementation - dynamic warm-up, strength exercises, football fundamentals, and education. In the control arm, no additional resources, education, or support will be provided.

Other: Educational materials

Interventions

Coaching OTHER

Physiotherapists (trained by the research team) train the coaches to deliver Prep-to-Play. The Physiotherapists will also provide face-to-face one-to-one support to each coach at their team's training session (two visits), with all their players.

Supported Implementation (Intervention)

Peer support OTHER

Coaches shed. Coaches provide each other with support and ideas. Strategies to overcome barriers and motivate players.

Supported Implementation (Intervention)

Educational materials OTHER

Prep-to-Play program resources are available online for coaches and players to view

Supported Implementation (Intervention); Unsupported implementation (Control)

Eligibility Criteria

• Age: 14 Years+
• Gender Eligibility Details: Participant eligibility is based on self-representation of gender identity.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Coach consents to be trained and to implement Prep-to-Play
• Team includes players aged 13 years and above registered to play community football
• The team trains at least once per week in addition to match-play
• Coach has at least Level I coach accreditation (or enrolled to be accredited in 2021)

You may not qualify if:

• Inability to understand written English
• Players aged less than 13 years

Sponsors & Collaborators

• La Trobe University: lead

Study Sites (1)

Community Australian Football Leagues

Melbourne, Victoria, 3121, Australia

RECRUITING

Related Publications (1)

• Patterson BE, Donaldson A, Cowan SM, King MG, Barton CG, McPhail SM, Hagglund M, White NM, Lannin NA, Ackerman IN, Dowsey MM, Hemming K, Makdissi M, Culvenor AG, Mosler AB, Bruder AM, Choong J, Livingstone N, Elliott RK, Nikolic A, Fitzpatrick J, Crain J, Haberfield MJ, Roughead EA, Birch E, Lampard SJ, Bonello C, Chilman KL, Crossley KM. Evaluation of an injury prevention programme (Prep-to-Play) in women and girls playing Australian Football: design of a pragmatic, type III, hybrid implementation-effectiveness, stepped-wedge, cluster randomised controlled trial. BMJ Open. 2022 Sep 14;12(9):e062483. doi: 10.1136/bmjopen-2022-062483.

  PMID: 36104145 DERIVED

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries; Brain Concussion

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating

Study Officials

• Kay Crossley, PhD, PT

  La Trobe University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sallie Cowan, PhD, PT

CONTACT

+61 (03) 94793483; Sallie.Cowan@latrobe.edu.au

Brooke Patterson, PhD, PT

CONTACT

+61 (03) 94793483; B.Patterson@latrobe.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: It will not be possible to blind all involved research fellows, or the Prep-to-Play Physiotherapists involved in the project. The statistician will be unblinded to information required to complete the analyses (i.e. timing of transition) but blinded to team information (e.g. location, name). Teams will be given a unique code. To optimise allocation concealment: i) each cluster will be a league or leagues in a unique geographical area; ii) data collection at all sites will commence in the control period, iii) team designate and/or sports trainers will remain blinded to allocation sequence; iv) Prep-to-Play observers validating the primary outcome (Prep-to-Play implementation) will be independent to the club and blinded to allocation; v) research fellows collecting injury data will be independent of the club and blinded to allocation.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Stepped-wedge randomised controlled trial. Prior to study initiation, the leagues will be randomly allocated to one of the five wedges for time of crossover from the control to the intervention phase using a computer-generated list of random numbers provided by a statistician. The randomisation sequence will be concealed to the coaches until shortly before the switch (\~four weeks to allow time to organise their workshop).

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 23, 2021
• Study Start: April 22, 2021
• Primary Completion: April 13, 2025
• Study Completion: December 21, 2025
• Last Updated: October 11, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)