Clinical trial NCT04856241: Making Football Safer for Women: Implementing an Injury Prevention Program
Official title: Prep-to-Play: Comparing the Impact of Supported and Unsupported Implementation Strategies on the Use of an Injury Prevention Program in Women's/Girl's Community Football
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anterior Cruciate Ligament Injuries
Concussion, Brain
Musculoskeletal Injury
Keywords: injury prevention
implementation
football
female
Lead sponsor: La Trobe University
Sponsor class: OTHER
First posted: 2021-04-23
Enrollment: 2600
Sex: FEMALE
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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).
Primary purpose: PREVENTION

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.

Detailed description: Primary Aim: To compare the impact of supported and unsupported implementation strategies on the use of an IP program (Prep-to-Play) in female community Australian Football.

Secondary aims are to:

1. Evaluate the effects of supported implementation of Prep-to-Play on injury risk reduction.
2. Identify barriers and enablers to sustainability of the Prep-to-Play implementation model, and develop clear recommendations for a future, sustainable national roll out of Prep-to-Play.
3. Evaluate the cost-effectiveness of Prep-to-Play.

Primary hypothesis

The primary hypothesis is that supported implementation will result in increased use of Prep-to-Play in female community Australian Football compared to unsupported implementation.

Secondary hypotheses

The secondary hypotheses are that the supported implementation of Prep-to-Play will:

* result in a reduction of anterior cruciate ligament (ACL) injuries in females participating in community Australian Football;
* result in a reduction of other musculoskeletal injuries and concussion among females participating in community Australian Football;
* be more cost-effective than the unsupported implementation.

Eligibility criteria: Inclusion Criteria

* 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)

Exclusion Criteria:

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

Primary outcomes:
measure: Use of Prep-to-Play (Primary outcome)
timeFrame: 18 months
Secondary outcomes:
measure: Number of players with an ACL injury (Secondary outcome)
timeFrame: 18 months
measure: Number of players with a concussion (Secondary outcome)
timeFrame: 18 months
measure: Number of player hours (training and match)
timeFrame: 18 months
measure: Healthcare utilisation
timeFrame: 18 months
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Community Australian Football Leagues
state: Victoria
Study officials:
affiliation: La Trobe University
name: Kay Crossley, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.