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

Primary Purpose

Athletic Injuries

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
I-PROTECT model
Control group
Sponsored by
Lund University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Athletic Injuries

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Eva Ageberg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

I-PROTECT model

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Adoption and fidelity (coaches)
Coaches' weekly report if they have followed the program as intended.
Adoption and fidelity (players)
Players' weekly report if they have used programs. Experimental group only (no programs available for players in current practice).
Occurrence of any injury/illness/health problem
Players' weekly report about occurrence of any injury/illness/health problem affecting handball training and/or match in the past week, using the Swedish version of the Oslo Sports Trauma Research Center health questionnaire.
Implementation determinants
Questionnaire data for implementation determinants will be collected for players, 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.
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.

Full Information

First Posted
March 7, 2022
Last Updated
January 17, 2023
Sponsor
Lund University
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1. Study Identification

Unique Protocol Identification Number
NCT05304507
Brief Title
Pilot Study of a Tailored Model for Implementation of Injury Prevention Training in Youth Handball (the I-PROTECT Model)
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
March 7, 2022 (Actual)
Primary Completion Date
June 22, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lund University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Athletic Injuries

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Non-randomized pilot study
Masking
Outcomes Assessor
Masking Description
An independent statistician, blinded to group allocation, will analyze data
Allocation
Non-Randomized
Enrollment
597 (Actual)

8. Arms, Groups, and Interventions

Arm Title
I-PROTECT model
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
I-PROTECT model
Intervention Description
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
Intervention Name(s)
Control group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Frequency of injury prevention training
Description
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).
Time Frame
Study start up to end of study (6 weeks)
Secondary Outcome Measure Information:
Title
Adoption and fidelity (coaches)
Description
Coaches' weekly report if they have followed the program as intended.
Time Frame
Study start up to end of study (6 weeks)
Title
Adoption and fidelity (players)
Description
Players' weekly report if they have used programs. Experimental group only (no programs available for players in current practice).
Time Frame
Study start up to end of study (6 weeks)
Title
Occurrence of any injury/illness/health problem
Description
Players' weekly report about occurrence of any injury/illness/health problem affecting handball training and/or match in the past week, using the Swedish version of the Oslo Sports Trauma Research Center health questionnaire.
Time Frame
Study start up to end of study (6 weeks)
Title
Implementation determinants
Description
Questionnaire data for implementation determinants will be collected for players, 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.
Time Frame
Baseline
Title
Implementation determinants
Description
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.
Time Frame
After study end at approx. 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Ageberg, PhD, Prof
Organizational Affiliation
Lund University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eva Ageberg
City
Lund
ZIP/Postal Code
22100
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Share published data on reasonable request
Citations:
PubMed Identifier
32019772
Citation
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.
Results Reference
background

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

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