Implementing Injury Prevention Training in Youth Handball (I-PROTECT) Using the RE-AIM Evaluation Framework

Study Overview
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Brief Summary
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The aim of this two-armed cluster-randomized controlled trial is to investigate the implementation of the I-PROTECT using the RE-AIM evaluation framework that addresses five dimensions of effectiveness and implementation of interventions: reach, effectiveness, adoption, implementation, and maintenance.

Detailed Description
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The 'Implementing injury Prevention training ROutines in TEams and Clubs in youth Team handball (I-PROTECT)' project was initiated through dialogue between end-users and researchers with the goal of making injury prevention training an integral part of regular practice in youth handball through a series of studies. Numerous implementation barriers and facilitators were identified in previous studies within the I-PROTECT project. These determinants were addressed when designing the intervention. The current study was planned with the Swedish Handball Federation, an organization with overall responsibility for handball in Sweden, to investigate whether I-PROTECT will work under real-world conditions and become part of regular handball practice. The specific aim is to investigate the implementation of I-PROTECT using the RE-AIM evaluation framework that addresses five dimensions of effectiveness and implementation of interventions: reach, effectiveness, adoption, implementation, and maintenance. Reach (R) is the absolute number, proportion and representativeness of individuals who are willing to participate in a given intervention. Effectiveness (E) is the impact of the intervention on outcomes. Adoption (A) is the absolute number, proportion and representativeness of settings and intervention agents who are willing to use the intervention. Implementation (I) refers to the intervention agents' fidelity to the various elements of the intervention's protocol. Maintenance (M) is the extent to which the intervention is sustained over time. The design will be a pragmatic two-armed cluster-randomized controlled trial (cluster-RCT) conforming to the Consolidated Standards of Reporting Trials (CONSORT) statement extension to cluster-randomized trials. Eighteen randomly selected clubs in Sweden offering handball for both female and male youth players, will be randomized to intervention (I-PROTECT) or control (currently available injury prevention training). Implementation outcomes will be investigated using RE-AIM evaluation framework, collected using a study-specific questionnaire approx. 2 months and 9 months after study start.

Official Title
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Implementing Injury Prevention Training in Youth Handball (I-PROTECT) Using the RE-AIM Evaluation Framework: A Cluster-randomized Trial

Conditions
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Athletic Injuries, Health Behavior

Intervention / Treatment
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* Behavioral: I-PROTECT
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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Stakeholders (players, coaches, caregivers, club administrators) of all youth teams in randomly selected community handball clubs will be eligible for participation. Inclusion Criteria: Clubs: Clubs in Sweden offering handball for both female and male youth players Teams: Training ≥2 times per week Youth players: Playing in boys' or girls' teams aged 12-16 years season 2022/2023 Coaches: leading ≥1 training session/week Caregivers: directly associated with the eligible players Club administrators: engaged in the issues of sports injury, coach education or policy development for youth players Exclusion Criteria: Clubs with previous involvement in developing and/or testing I-PROTECT Clubs that offer handball exclusively for either female or male players Teams with players 17 years or older Employed/paid players Stakeholder other than the groups listed in inclusion criteria

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cluster-randomized study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I-PROTECT<br>I-PROTECT includes physical and psychological injury prevention information and training (i.e., the intervention) and tailored support to implement it specifically developed for Swedish community youth handball. | Behavioral: I-PROTECT<br>* I-PROTECT 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 end-user-targeted information and injury prevention physical and psychological training, specifically tailored for youth handball. The intervention is delivered through a mobile application (I-PROTECT GO) specifically developed for the I-PROTECT project, including coach, player, club administrator, and caregiver modules. Tailored support to implement I-PROTECT is specifically developed for Swedish community youth handball.<br>|
| Active Comparator: Control group<br>Coaches of youth teams in the control group clubs will be offered currently available injury prevention training (i.e., Redo för Handboll, English: Ready for Handball), accessible online through the Swedish Handball Federation's coach education material. | Behavioral: Control<br>* Coaches of youth teams in the control group clubs will be offered currently available injury prevention training (i.e., Redo för Handboll, English: Ready for Handball), accessible online through the Swedish Handball Federation's coach education material.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reach Reach as measured by absolute number and proportion of individuals who participate | Reach outcomes will be: Proportion of eligible stakeholders that register to use the app (players, coaches, club administrators, caregivers), consent to participate (coaches, club administrators), attend online education (coaches, club administrators), and respond to a questionnaire (players, coaches, club administrators). | 2-month follow-up | 
| Effectiveness as measured by risk perception | Risk perception (overall injury risk) is measured on a 7-point rating scale (from extremely low to extremely high) aligned with the Health Action Process Approach (HAPA) (players, coaches, club administrators) | 2-month follow-up | 
| Effectiveness as measured by outcome expectancies | Outcome expectancies (how preventable injuries are) is measured on a 7-point rating scale (from extremely not preventable to extremely preventable) aligned with the Health Action Process Approach (HAPA) (players, coaches, club administrators) | 2-month follow-up | 
| Effectiveness as measured by perceived effectiveness | Perceived effectiveness (whether intervention has improved condition/behavior) is measured on a 5-point rating scale (from strongly disagree to strongly agree) from the generic form of The theoretical framework of acceptability (TFA) questionnaire (players, coaches, club administrators) | 2-month follow-up | 
| Adoption as measured by use | Adoption is measured as having used any components and/or exercises (yes/no) (players, coaches, club administrators) | 2-month follow-up | 
| Adoption as measured by affective attitude | Affective attitude to intervention is measured on a 5-point rating scale (from strongly dislike to strongly like) from the TFA questionnaire (players, coaches, club administrators) | 2-month follow-up | 
| Adoption as measured by intervention coherence | Intervention coherence (participant understands how intervention works) is measured on a 5-point rating scale (from strongly disagree to strongly agree) from the TFA questionnaire (players, coaches, club administrators) | 2-month follow-up | 
| Adoption as measured by action self-efficacy (players) | Self-efficacy (confidence about using intervention) is measured on a 5-point rating scale (from very unconfident to very confident) from the TFA questionnaire | 2-month follow-up | 
| Adoption as measured by action self-efficacy (coaches, club administrators) | Self-efficacy (confidence about using intervention) is measured on a 7-point rating scale (from extremely not confident to extremely confident) aligned with the Health Action Process Approach (HAPA) | 2-month follow-up | 
| Adoption as measured by burden | Burden to use intervention is measured on a 5-point rating scale (from no effort at all to huge effort) from the TFA questionnaire (coaches, club administrators) | 2-month follow-up | 
| Adoption as measured by opportunity costs | Opportunity costs (whether intervention interfered with other priorities) is measured on a 5-point rating scale (from strongly disagree to strongly agree) from the TFA questionnaire (coaches, club administrators) | 2-month follow-up | 
| Adoption as measured by acceptability | General acceptability is measured on a 5-point rating scale (from completely unacceptable to completely acceptable) from the TFA questionnaire (players, coaches, club administrators) | 2-month follow-up | 
| Adoption as measured by perceived usefulness | Perceived usefulness is measured on a 7-point rating scale (from strongly disagree to strongly agree) aligned with the Health intervention Technology Acceptance Model (HITAM) (players, coaches, club administrators) | 2-month follow-up | 
| Adoption as measured by ease of use | Ease of use is measured on a 7-point rating scale (from strongly disagree to strongly agree) aligned with the Health intervention Technology Acceptance Model (HITAM) (players, coaches, club administrators) | 2-month follow-up | 
| Implementation as measured by adherence | Adherence (frequency) of using intervention (players, coaches, club administrators) | 2-month follow-up | 
| Implementation as measured by fidelity to program (players, coaches) | Fidelity to program (proportion and type of exercises) | 2-month follow-up | 
| Implementation as measured by fidelity to program (club administrators) | Fidelity to implementation checklist (proportion of use) | 2-month follow-up | 
| Implementation as measured by coping planning | Plan to deal with challenges is measured on a 7-point rating scale (from extremely disagree to extremely agree) aligned with the Health Action Process Approach (HAPA) (coaches, club administrators) | 2-month follow-up | 
| Maintenance as measured by intention | Intention to use intervention in the future is measured on a 7-point rating scale (from extremely not likely to extremely likely) aligned with the Health Action Process Approach (HAPA) (players, coaches, club administrators) | 2-month follow-up | 
| Maintenance intention as measured by self-efficacy | Maintenance self-efficacy (confidence about continuing to use intervention) is measured 7-point rating scale (from extremely not confident to extremely confident) aligned with the Health Action Process Approach (HAPA) (players, coaches, club administrators) | 2-month follow-up | 
| Maintenance intention as measured by recovery self-efficacy | Recovery self-efficacy (confidence about starting to use intervention again) is measured 7-point rating scale (from extremely not confident to extremely confident) aligned with the Health Action Process Approach (HAPA) (players, coaches, club administrators) | 2-month follow-up | 
| Actual maintenance as measured by adoption | Adoption is measured as having used any components and/or exercises (yes/no) (players, coaches, club administrators) | 9-month follow-up | 
| Actual maintenance as measured by adherence | Adherence (frequency) of using intervention (players, coaches, club administrators) | 9-month follow-up | 
| Actual maintenance as measured by fidelity (players, coaches) | Fidelity to program (proportion and type of exercises) | 9-month follow-up | 
| Actual maintenance as measured by fidelity (club administrators) | Fidelity to implementation checklist (proportion of use) | 9-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implementation determinants | Data will be gathered (e.g., individual or focus groups interviews) to enable an in-depth understanding of potential and actual barriers and facilitators, acceptability, usability, and sustainability of I-PROTECT, including its packaging. | After follow-up, approx. 10 months after study start | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical activity, Preventive therapy, Adolescent, Health plan implementation, Behaviour change