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| ID | Type | Description | Link |
|---|---|---|---|
| 2014/713 | Other Identifier | Regional Ethical Review Board in Lund, Sweden |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eva Ageberg, PhD | Lund University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eva Ageberg | Lund | 22100 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41496745 | Result | 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. | |
| 40640037 | 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. |
| Label | URL |
|---|---|
| Ageberg et al. Implementing injury prevention training in youth handball (I-PROTECT) in Sweden: Study protocol for a cluster-randomized trial | View source |
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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.
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| ID | Term |
|---|---|
| D001265 | Athletic Injuries |
| D015438 | Health Behavior |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D001519 | Behavior |
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Cluster-randomized study
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An independent statistician, blinded to group allocation, will analyze data
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| 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. |
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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 |
| 40018138 | 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. |