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Athletic InjuriesI-PROTECTNCT05696119

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

A study testing I-PROTECT in people with Athletic Injuries and Health Behavior, run by Lund University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 years and olderHealthy volunteers can take part
Conditions the study is for
Athletic Injuries, Health Behavior
What is being tested?
I-PROTECT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,225 participants
Where
1 siteSweden
Study dates
31 May 2023to 18 Oct 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • Eva Ageberg

    Lund, 22100

Other trials in Sweden

About this study

Official title: 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.

Read the 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).

Being tested
I-PROTECT, Control
Keywords
Physical activity, Preventive therapy, Adolescent, Health plan implementation, Behaviour change
Medical subject headings
Athletic Injuries, Health Behavior, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • I-PROTECTBehavioural

    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.

  • ControlBehavioural

    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.

Study groups in NCT05696119
Study groupRoleWhat they receive
I-PROTECTExperimentalI-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.
Receives: Behavioral: I-PROTECT
Control groupActive comparatorCoaches 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.
Receives: Behavioral: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 9-month follow-up

  2. 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)

    Measured: 9-month follow-up

  3. 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)

    Measured: 9-month follow-up

  4. 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)

    Measured: 9-month follow-up

  5. Adoption as measured by use

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

    Measured: 9-month follow-up

  6. 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)

    Measured: 9-month follow-up

  7. 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)

    Measured: 9-month follow-up

  8. 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)

    Measured: 9-month follow-up

  9. 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)

    Measured: 9-month follow-up

  10. 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)

    Measured: 9-month follow-up

  11. 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)

    Measured: 9-month follow-up

  12. Implementation as measured by adherence

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

    Measured: 9-month follow-up

  13. Implementation as measured by fidelity to program

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

    Measured: 9-month follow-up

  14. Implementation as measured by fidelity to implementation checklist

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

    Measured: 9-month follow-up

  15. 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)

    Measured: 9-month follow-up

  16. 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)

    Measured: 9-month follow-up

  17. 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)

    Measured: 9-month follow-up

Secondary outcomes (1)
  1. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2023
  2. Study start31 May 2023
  3. Primary completion31 May 2024
  4. Study completion18 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Cluster-randomized study
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
4,225 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05696119
Sponsor's protocol ID
2022-06148-02
Other IDs
2014/713
Acronym
I-PROTECT
Status last verified
Mar 2025
First submitted
13 Dec 2022
Last updated
14 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

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.

    PubMed 41496745
  • 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.

    PubMed 40640037
  • 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.

    PubMed 40018138

Questions about this trial

What is this clinical trial studying?

A study testing I-PROTECT in people with Athletic Injuries and Health Behavior, run by Lund University at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reach as measured by absolute number and proportion of individuals who participate (time frame: 9-month follow-up). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05696119, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.

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