NCT05304507

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
597

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

March 7, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

4 months

First QC Date

March 7, 2022

Last Update Submit

November 22, 2023

Conditions

Athletic Injuries

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Adoption and fidelity (coaches)

    Study start up to end of study (6 weeks)

  • Implementation determinants

    Baseline

  • Implementation determinants

    After study end at approx. 6 weeks

Study Arms (2)

I-PROTECT model

EXPERIMENTAL

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.

Behavioral: I-PROTECT model

Control group

ACTIVE COMPARATOR

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.

Behavioral: Control group

Interventions

I-PROTECT modelBEHAVIORAL

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.

I-PROTECT model
Control groupBEHAVIORAL

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.

Control group

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Employed/paid players

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eva Ageberg

Lund, 22100, Sweden

Location

Related 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.

    PMID: 32019772BACKGROUND

MeSH Terms

Conditions

Athletic Injuries

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Eva Ageberg, PhD, Prof

    Lund University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
An independent statistician, blinded to group allocation, will analyze data
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Non-randomized pilot study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2022

First Posted

March 31, 2022

Study Start

March 7, 2022

Primary Completion

June 22, 2022

Study Completion

December 31, 2022

Last Updated

November 29, 2023

Record last verified: 2023-11

Locations

SE(1)