Pilot Study of a Tailored Model for Implementation of Injury Prevention Training in Youth Handball (the I-PROTECT Model)

NCT ID: NCT05304507

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

597 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-07

Study Completion Date

2022-12-31

Brief Summary

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This pilot study aims to test a tailored model (the I-PROTECT model) for implementation of injury prevention training in youth handball compared with current practice.

Detailed Description

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Injury prevention training is effective in reducing musculoskeletal injuries in youth athletes but has had limited public health impact because it is not widely or properly implemented. The lack of involving end-users at the individual and organizational levels is a main contributor to insufficient implementation.

This is a non-randomized pilot study included in the "Implementing injury Prevention training ROutines in TEams and Clubs in youth Team handball (I-PROTECT)" project. The overall aim of I-PROTECT is to achieve wide-spread, sustained and high-fidelity use of evidence-based injury prevention training in youth handball through behavior change at multiple levels within the sports delivery system (individual and organizational levels). The I-PROTECT model is evidence-based, theory-informed, and context-specific injury prevention training specifically tailored for youth handball players, incorporating physical and psychological components and an associated implementation strategy. The process of developing the I-PROTECT model has been described.

In a prospective single-case study (ClinicalTrials.gov registration number: NCT04481958), the I-PROTECT model was implemented and tested in all youth teams (n=19) of two clubs during the 2020/2021 handball season. Due to Covid pandemic restrictions, handball training was only performed for about 2 months, thus, affecting intervention implementation and data collection. To further evaluate, develop, and finalize the I-PROTECT model, we will in the current study conduct pilot testing in clubs not involved in developing the model, before testing the model in a larger scale study.

Two clubs in Sweden offering handball for youth players will be recruited by convenience sampling. One club will use the I-PROTECT model (experimental) and one club will use current practice (control). Intervention will be approx. 6 weeks. Data will be collected among stakeholders (players, coaches, club administrators, caregivers) before, during and after the intervention. Parametric, or non-parametric, tests will be used as appropriate for main and secondary outcomes. Data will be used to calculate sample size in the main outcome for a larger scale study as well as to assess implementation determinants.

Conditions

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Athletic Injuries

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Non-randomized pilot study
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
An independent statistician, blinded to group allocation, will analyze data

Study Groups

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I-PROTECT model

The I-PROTECT model is an end-user-driven intervention including evidence-based, theory-informed, and context-specific injury prevention training for youth handball, and an associated implementation strategy.

Group Type EXPERIMENTAL

I-PROTECT model

Intervention Type BEHAVIORAL

The I-PROTECT model is based on existing research and knowledge of experts in sport medicine, sport psychology and implementation science, with the involvement of end-users throughout the process. The interdisciplinary intervention includes exercises based on physical and psychological principles of effective injury prevention training, specifically tailored for youth handball players, and support for developing a continuous implementation strategy. The intervention is delivered through a mobile application specifically developed for the I-PROTECT project (the I-PROTECT GO), including coach, player, club administrator, and caregiver modules. Coaches are introduced to the intervention in a workshop, and they will conduct the exercises with their teams during handball practice. Players will have support for conducting exercises on their own, and club administrators for developing an implementation strategy. Caregivers will have tailored information about injury prevention training.

Control group

Youth coaches in the control group club will be asked to use injury prevention training available in the coach education material ("Ready for handball"), i.e., current practice in Sweden.

Group Type ACTIVE_COMPARATOR

Control group

Intervention Type BEHAVIORAL

Youth coaches in the control group club will be asked to use injury prevention training available in the coach education material ("Ready for handball"), i.e., current practice in Sweden.

Interventions

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I-PROTECT model

The I-PROTECT model is based on existing research and knowledge of experts in sport medicine, sport psychology and implementation science, with the involvement of end-users throughout the process. The interdisciplinary intervention includes exercises based on physical and psychological principles of effective injury prevention training, specifically tailored for youth handball players, and support for developing a continuous implementation strategy. The intervention is delivered through a mobile application specifically developed for the I-PROTECT project (the I-PROTECT GO), including coach, player, club administrator, and caregiver modules. Coaches are introduced to the intervention in a workshop, and they will conduct the exercises with their teams during handball practice. Players will have support for conducting exercises on their own, and club administrators for developing an implementation strategy. Caregivers will have tailored information about injury prevention training.

Intervention Type BEHAVIORAL

Control group

Youth coaches in the control group club will be asked to use injury prevention training available in the coach education material ("Ready for handball"), i.e., current practice in Sweden.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Players: ages 13-17 years and training ≥2 times/week in a team
* Coaches: leading ≥1 training session/week
* Caregivers: directly associated with the eligible players
* Club administrators: engagement in the issues of sports injury, coach education or policy development for youth players

Exclusion Criteria

* Employed/paid players
Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Lund University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eva Ageberg, PhD, Prof

Role: PRINCIPAL_INVESTIGATOR

Lund University

Locations

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Eva Ageberg

Lund, , Sweden

Site Status

Countries

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Sweden

References

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Ageberg E, Bunke S, Nilsen P, Donaldson A. Planning injury prevention training for youth handball players: application of the generalisable six-step intervention development process. Inj Prev. 2020 Apr;26(2):164-169. doi: 10.1136/injuryprev-2019-043468. Epub 2020 Feb 4.

Reference Type BACKGROUND
PMID: 32019772 (View on PubMed)

Other Identifiers

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2014/713

Identifier Type: OTHER

Identifier Source: secondary_id

2020-02952

Identifier Type: -

Identifier Source: org_study_id