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临床试验/NCT04856241
NCT04856241招募中不适用

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

La Trobe University2 个研究点 分布在 1 个国家目标入组 2,600 人开始时间: 2021年4月22日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
2,600
试验地点
2
主要终点
Use of Prep-to-Play (Primary outcome)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
14 Years 至 —(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

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

结局指标

主要结局

Use of Prep-to-Play (Primary outcome)

时间窗: 18 months

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.

次要结局

  • Number of player hours (training and match)(18 months)
  • Number of players with an ACL injury (Secondary outcome)(18 months)
  • Number of players with a concussion (Secondary outcome)(18 months)
  • Healthcare utilisation(18 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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