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

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

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.

Study Overview

• Status: Completed
• Conditions: Athletic Injuries; Health Behavior
• Intervention / Treatment: Behavioral: I-PROTECT; Behavioral: Control

Detailed Description

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 at the end of the season (approx. 9 months after study start).

• Study Type: Interventional
• Enrollment (Actual): 4225
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Lund, Sweden, 22100
    • Eva Ageberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 2023/2024
• Coaches: leading ≥1 training session/week
• Parents/guardians: 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: I-PROTECT; 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; 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.
Active Comparator: Control group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	9-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)	9-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)	9-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)	9-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)	9-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 (coaches, club administrators)	9-month follow-up
Adoption as measured by self-efficacy	Self-efficacy (confidence about using intervention) is measured on a 5-point rating scale (from very unconfident to very confident) from the TFA questionnaire (players, coaches, club administrators)	9-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)	9-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)	9-month follow-up
Adoption as measured by ease of use	Ease of use is measured on a 5-point rating scale (from strongly disagree to strongly agree) (players, coaches, club administrators)	9-month follow-up
Implementation as measured by adherence	Adherence (frequency) of using intervention (players, coaches, club administrators)	9-month follow-up
Implementation as measured by fidelity to program	Fidelity to program, i.e. the proportion and type of exercises (players, coaches)	9-month follow-up
Implementation as measured by fidelity to implementation checklist	Fidelity to implementation checklist, i.e. proportion of use (club administrators)	9-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)	9-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)	9-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) (coaches, club administrators)	9-month follow-up
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/or respond to a questionnaire (players, coaches, club administrators).	9-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implementation determinants	Data will be gathered (e.g., workshops) 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

Collaborators and Investigators

• Sponsor: Lund University
• Investigators: Principal Investigator: Eva Ageberg, PhD, Lund University

Publications and helpful links

General Publications

• Lucander K, Reuter A, Donaldson A, Almqvist Nae J, Ageberg E. Coaches' perspectives on the implementation of injury prevention training in youth handball: a qualitative study. BMJ Open Sport Exerc Med. 2025 Dec 31;11(4):e002783. doi: 10.1136/bmjsem-2025-002783. eCollection 2025.
• Ageberg E, Donaldson A, Lucander K, Strom A, Moesch K, Bunke S, Linnell J, Wedberg R, Ekberg P, Nilsen P. Will a co-created program enhance implementation of injury prevention training in youth handball in Sweden? A cluster-randomized controlled trial. J Sci Med Sport. 2025 Nov;28(11):907-915. doi: 10.1016/j.jsams.2025.06.011. Epub 2025 Jun 27.
• Ageberg E, Donaldson A, Strom A, Lucander K, Moesch K, Bunke S, Linnell J, Wedberg R, Ekberg P, Nilsen P. Implementing injury prevention training in youth handball (I-PROTECT) in Sweden: study protocol for a cluster randomised trial. BMJ Public Health. 2024 Jul 30;2(1):e000991. doi: 10.1136/bmjph-2024-000991. eCollection 2024 Jun.

Helpful Links

• Ageberg et al. Implementing injury prevention training in youth handball (I-PROTECT) in Sweden: Study protocol for a cluster-randomized trial

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2023
• Primary Completion (Actual): May 31, 2024
• Study Completion (Actual): October 18, 2024

Study Registration Dates

• First Submitted: December 13, 2022
• First Submitted That Met QC Criteria: January 23, 2023
• First Posted (Actual): January 25, 2023

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Adolescent; Physical activity; Behaviour change; Preventive therapy; Health plan implementation
• Additional Relevant MeSH Terms: Wounds and Injuries; Behavior; Athletic Injuries; Motor Activity; Health Behavior
• Other Study ID Numbers: 2022-06148-02; 2014/713 (Other Identifier: Regional Ethical Review Board in Lund, Sweden)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

The current approval by the Regional Ethical Review Board in Lund, Sweden (2014/713, 2020-02952, 2022-06148-02) does not include data sharing. A minimal data set could be shared by request from a qualified academic investigator for the sole purpose of replicating the present study, provided the data transfer is in agreement with EU legislation on the general data protection regulation and approval by the Swedish Ethical Review Authority.

Contact information:

Department of Health Sciences, Lund University Box 157, 221 00 Lund, Sweden Contact address: DHSdataaccess@med.lu.se

Principal Investigator: Eva Ageberg, Department of Health Sciences, Lund University Box 157, 221 00 Lund, Sweden. Email: eva.ageberg@med.lu.se

Swedish Ethical Review Authority, Box 2110, 75 002 Uppsala, Sweden. Phone: +46 10 475 08 00.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No