Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04856241




Registration number
NCT04856241
Ethics application status
Date submitted
14/04/2021
Date registered
23/04/2021
Date last updated
11/10/2023

Titles & IDs
Public title
Making Football Safer for Women: Implementing an Injury Prevention Program
Scientific 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
Secondary ID [1] 0 0
P2P NHMRC 1193733
Universal Trial Number (UTN)
Trial acronym
Prep-to-Play
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anterior Cruciate Ligament Injuries 0 0
Concussion, Brain 0 0
Musculoskeletal Injury 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Skin 0 0 0 0
Other skin conditions
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Coaching
Other interventions - Peer support
Other interventions - Educational materials

Experimental: Supported Implementation (Intervention) - 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.

Active Comparator: Unsupported implementation (Control) - 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 interventions: Coaching
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.

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

Other interventions: Educational materials
Prep-to-Play program resources are available online for coaches and players to view
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
18 months
Secondary outcome [1] 0 0
Number of players with an ACL injury (Secondary outcome) - The primary injuries of interest are ACL injuries and concussion. An ACL/all other injuries will be defined as any injury occurring during a football match or training that results in a player being unable to return to the field of play for that match, or missing at least one match.
ACL injury definition
• Ruptured ACL is confirmed by clinical examination, with or without magnetic resonance imaging or surgery.
Injury data will be collected via two methods to minimise missing data: (i) sports trainer; (ii) direct from player
Timepoint [1] 0 0
18 months
Secondary outcome [2] 0 0
Number of players with a concussion (Secondary outcome) - A head injury will be defined as any injury to the head region occurring during a football match or training, regardless of time loss.
Concussion definition
• Direct or indirect impact to the head resulting in loss of consciousness and/or any of the following clinical symptoms (memory loss, headache, dizziness, nausea, difficulty concentrating, feeling like being in a fog, feeling not quite right).
Injury data will be collected via two methods to minimise missing data: (i) sports trainer; (ii) direct from player
Timepoint [2] 0 0
18 months
Secondary outcome [3] 0 0
Number of player hours (training and match) - The number of training and match hours for each team will be collected, and reported at a team-level. Weekly team match exposure will be estimated from the number of matches played, multiplied by the number of players in each match (publicly available registry), and the match length (junior: 1 hour, senior: 1.5 hours). Weekly team training exposure will be estimated using the number and duration of football training sessions completed (reported by team designates), multiplied by the average number of players at training (reported by independent observers on five occasions).
Timepoint [3] 0 0
18 months
Secondary outcome [4] 0 0
Healthcare utilisation - Healthcare use for players sustaining a knee or head injury will be obtained by the blinded research officer to estimate healthcare costs of sustaining an injury to inform health economic evaluation.
Timepoint [4] 0 0
18 months

Eligibility
Key inclusion 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)
Minimum age
14 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Inability to understand written English

- Players aged less than 13 years

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/04/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
21/12/2025
Actual
Sample size
Target
2600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Community Australian Football Leagues - Melbourne
Recruitment postcode(s) [1] 0 0
3121 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
La Trobe University
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04856241
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kay Crossley, PhD, PT
Address 0 0
La Trobe University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sallie Cowan, PhD, PT
Address 0 0
Country 0 0
Phone 0 0
+61 (03) 94793483
Fax 0 0
Email 0 0
Sallie.Cowan@latrobe.edu.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04856241