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

NCT05696119 | Completed

• 2 other identifiers: 2022-06148-022014/713
• Study Type: interventional
• Target: 4,225
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Athletic Injuries; Health Behavior

Keywords

Physical activity; Preventive therapy; Adolescent; Health plan implementation; Behaviour change

Outcome Measures

Primary Outcomes (17)

• 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

• 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

Secondary Outcomes (1)

• Implementation determinants

  After follow-up, approx. 10 months after study start

Study Arms (2)

I-PROTECT

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

I-PROTECT BEHAVIORAL

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.

I-PROTECT

Control BEHAVIORAL

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.

Control group

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lund University: lead

Study Sites (1)

Eva Ageberg

Lund, 22100, Sweden

Location

Related Publications (3)

• 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.

  PMID: 41496745 RESULT

• 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.

  PMID: 40640037 RESULT

• 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.

  PMID: 40018138 RESULT

Related Links

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

MeSH Terms

Conditions

Athletic Injuries; Health Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Wounds and Injuries; Behavior

Study Officials

• Eva Ageberg, PhD

  Lund University

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Cluster-randomized study

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: January 25, 2023
• Study Start: May 31, 2023
• Primary Completion: May 31, 2024
• Study Completion: October 18, 2024
• Last Updated: April 14, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)