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

Athletic Injuries Clinical Trial

— I-PROTECT  

Official title:

Tailored Model for Implementation of Injury Prevention Training in Youth Handball Compared With Current Practice: A Pilot Study of the I-PROTECT Model

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05304507
• Other study ID #: 2020-02952
• Secondary ID: 2014/713
• Status: Completed
• Phase: N/A
• Start date: March 7, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2023
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 597
• Est. completion date: December 31, 2022
• Est. primary completion date: June 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years and older

Eligibility

Stakeholders (players, coaches, caregivers, club administrators) of all youth teams (13-17 years) in two community handball clubs will be eligible for participation.

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
• Stakeholder other than the groups listed in inclusion criteria

Related Conditions & MeSH terms

• Athletic Injuries
• Wounds and Injuries

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
Sweden	Eva Ageberg	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Lund University

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of injury prevention training	Frequency of injury prevention training on a team level, reported by coaches weekly (0, 1, 2, 3 or more session/week). Using injury prevention training for two session or more per week at regular handball training over the intervention period will signify that injury prevention is implemented in a team (binary outcome: =2 per week or <2 per week).	Study start up to end of study (6 weeks)
Secondary	Adoption and fidelity (coaches)	Coaches' weekly report if they have followed the program as intended.	Study start up to end of study (6 weeks)
Secondary	Implementation determinants	Questionnaire data for implementation determinants will be collected for coaches and caregivers. Questions aligned with the Health Action Process Approach (HAPA) theory and the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework will be adapted to each stakeholder group.	Baseline
Secondary	Implementation determinants	Questionnaire or interview data for implementation determinants will be collected for all stakeholders (players, coaches, caregivers, club representatives). Questions aligned with the Health Action Process Approach (HAPA) theory and the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework will be adapted to each stakeholder group. Data will also be gathered (e.g., focus groups interviews) to enable an in-depth understanding of potential barriers and facilitators, acceptability, usability, and sustainability of the I-PROTECT model, including its packaging, and of potential barriers for filling in questionnaires.	After study end at approx. 6 weeks