Implementation of the I-PROTECT Model (I-PROTECT)

January 24, 2022 updated by: Eva Ageberg, Lund University

Implementation of Injury Prevention Training and an Associated Implementation Strategy in Youth Handball: A Pilot Study of the I-PROTECT Model

Evidence-based injury prevention training is highly effective in reducing sport-related musculoskeletal injuries in youth. However, this training has so far had limited public health impact because it is not widely or properly implemented or sustained. In this single case study with youth teams from two handball clubs in Southern Sweden, the aim is to test the I-PROTECT model, featuring injury prevention training and an associated implementation plan. The main hypothesis is that the intervention will result in higher motivational and volitional levels in relation to injury prevention training.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is a pilot study included in the "Implementing injury Prevention training ROutines in TEams and Clubs in youth Team handball (I-PROTECT)" project (Ageberg et al, 2019, 2020). 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 (Ageberg et al 2020). The current study is a prospective single case study for initial testing and evaluation of the I-PROTECT model (i.e., before the model is implemented in a larger scale study). The reporting will adhere to the SCRIBE guidelines. All youth teams in the two clubs with representatives of the stakeholder group overseeing the I-PROTECT project will use the I-PROTECT model for one handball season. The Health Action Process Approach (HAPA) theory will be used to evaluate behavior change among players, coaches and club administrators. The Reach, Effectiveness, Adoption, Implementation, and Maintenance Sport Setting Matrix (RE-AIM SSM) framework will be used to guide the evaluation of implementation outcomes of the I-PROTECT model among all stakeholders (players, coaches, club administrators, caregivers).

The main hypothesis is that the intervention increases scores in HAPA questions in coaches from pre- to post intervention by at least 30%, indicating higher motivational and volitional levels in relation to injury prevention training post intervention (end of season) compared to pre-intervention (baseline). A preliminary sample size calculation indicates that 42 coaches are needed to detect a clinically relevant change in behavior of at least 30% (baseline vs post intervention) with 80% power at the 5% significance level. Secondary outcomes will be: i) HAPA questions among players and club administrators; ii) RE-AIM SSM questions, descriptive data, and/or mobile application data among all stakeholders (players, coaches, club administrators, caregivers). Interviews (e.g., focus groups) with end-users will be conducted to enable an in-depth understanding of the feasibility, acceptability and usability of the program, including its packaging. An "exit strategy" will be employed to refine the model, address any potential barriers for implementation and sustainability, and embed the I-PROTECT model into the organizations that have participated in the study.

Due to pandemic restrictions, handball training was only performed as usual about 2 months at the start of the season, and evaluation of the I-PROTECT-model could not be conducted as planned. Nineteen teams with their coaches, players, and caregivers included (approx. 700 participants in total). The following data was collected:

  • Main outcome: HAPA questions for coaches at baseline and at end-of-season
  • Secondary outcomes: HAPA and RE-AIM questions caregivers at baseline

Study Type

Interventional

Enrollment (Actual)

700

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Lund, Sweden, 22100
        • Eva Ageberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Behavioral: I-PROTECT
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 (the I-PROTECT GO), including modules tailored for coaches, players, club administrators, and caregivers, respectively. Coaches are introduced to the intervention in a workshop, and they will conduct the exercises with their teams during handball practice. Due to pandemic restrictions, the mobile application could not be finalized, and only the module for coaches was available.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health Action Process Approach questions for coaches
Time Frame: Baseline to end-of-season (after approx. 8 months)
An adapted version of the Health Action Process Approach (HAPA), specifically related to injury prevention training for youth team handball, has been developed and adapted for coaches. The questions focus on motivational strategies (e.g., risk perception, outcome expectancies) and volitional strategies (e.g., action planning, maintenance self-efficacy) for behavior change regarding injury-prevention training.
Baseline to end-of-season (after approx. 8 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Descriptive information about the Covid-19 pandemic and use of I-PROTECT (coaches)
Time Frame: Baseline to end-of-season (after approx. 8 months)
Questions to coaches about use of I-PROTECT before and during pandemic restrictions
Baseline to end-of-season (after approx. 8 months)
Health Action Process Approach and Reach, Effectiveness, Adoption, Implementation, and Maintenance Sport Setting Matrix questions among caregivers
Time Frame: Baseline
Health Action Process Approach (HAPA) and Reach, Effectiveness, Adoption, Implementation, and Maintenance Sport Setting Matrix (RE-AIM SSM), specifically related to injury prevention training for youth team handball, adapted for caregivers
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lund University

Investigators

  • Principal Investigator: Eva Ageberg, PhD, Department of Health Sciences, Lund University, Lund, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 27, 2020

Primary Completion (ACTUAL)

January 24, 2022

Study Completion (ACTUAL)

January 24, 2022

Study Registration Dates

First Submitted

July 8, 2020

First Submitted That Met QC Criteria

July 19, 2020

First Posted (ACTUAL)

July 22, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 2, 2022

Last Update Submitted That Met QC Criteria

January 24, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014/713 (Other Identifier: Regional Ethical Review Board in Lund, Sweden)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Share published data on reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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