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Completed

NCT Number: NCT05696119

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

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.

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Key information

Conditions

Athletic Injuries Behavior Health Behavior Motor Activity Wounds and Injuries

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eva Ageberg

Lund, 22100, Sweden

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Reach as measured by absolute number and proportion of individuals who participate

    Time frame: 9-month follow-up

    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).

  2. Effectiveness as measured by risk perception

    Time frame: 9-month follow-up

    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)

  3. Effectiveness as measured by outcome expectancies

    Time frame: 9-month follow-up

    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)

  4. Effectiveness as measured by perceived effectiveness

    Time frame: 9-month follow-up

    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)

  5. Adoption as measured by use

    Time frame: 9-month follow-up

    Adoption is measured as having used any components and/or exercises (yes/no) (players, coaches, club administrators)

  6. Adoption as measured by affective attitude

    Time frame: 9-month follow-up

    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)

  7. Adoption as measured by intervention coherence

    Time frame: 9-month follow-up

    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)

  8. Adoption as measured by self-efficacy

    Time frame: 9-month follow-up

    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. Adoption as measured by burden

    Time frame: 9-month follow-up

    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)

  10. Adoption as measured by opportunity costs

    Time frame: 9-month follow-up

    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)

  11. Adoption as measured by ease of use

    Time frame: 9-month follow-up

    Ease of use is measured on a 5-point rating scale (from strongly disagree to strongly agree) (players, coaches, club administrators)

  12. Implementation as measured by adherence

    Time frame: 9-month follow-up

    Adherence (frequency) of using intervention (players, coaches, club administrators)

  13. Implementation as measured by fidelity to program

    Time frame: 9-month follow-up

    Fidelity to program, i.e. the proportion and type of exercises (players, coaches)

  14. Implementation as measured by fidelity to implementation checklist

    Time frame: 9-month follow-up

    Fidelity to implementation checklist, i.e. proportion of use (club administrators)

  15. Implementation as measured by coping planning

    Time frame: 9-month follow-up

    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)

  16. Maintenance as measured by intention

    Time frame: 9-month follow-up

    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)

  17. Maintenance intention as measured by self-efficacy

    Time frame: 9-month follow-up

    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)

Secondary outcomes

  1. Implementation determinants

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

    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.

Sponsors and collaborators

Lead sponsor

Lund University

Other

Registry information

Official study title

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

Acronym: I-PROTECT

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 25, 2023
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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