Register a trial

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04856241
Ethics application status
Date submitted
14/04/2021
Date registered
23/04/2021

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)
Timepoint [1] 0 0
18 months
Secondary outcome [1] 0 0
Number of players with an ACL injury (Secondary outcome)
Timepoint [1] 0 0
18 months
Secondary outcome [2] 0 0
Number of players with a concussion (Secondary outcome)
Timepoint [2] 0 0
18 months
Secondary outcome [3] 0 0
Number of player hours (training and match)
Timepoint [3] 0 0
18 months
Secondary outcome [4] 0 0
Healthcare utilisation
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04856241