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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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).
- Conditions
- Athletic Injuries, Health Behavior
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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
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
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
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
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
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
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
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
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
Implementation as measured by adherence
Adherence (frequency) of using intervention (players, coaches, club administrators)
Measured: 9-month follow-up
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
Implementation as measured by fidelity to implementation checklist
Fidelity to implementation checklist, i.e. proportion of use (club administrators)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 9-month follow-up
Secondary outcomes (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.
- First posted25 Jan 2023
- Study start31 May 2023
- Primary completion31 May 2024
- Study completion18 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Athletic InjuriesStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eva Ageberg, PhD, Principal investigator, Lund University
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 41496745Ageberg 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 40640037Ageberg 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Injury Prevention Training in Youth Handball (I-PROTECT) Using the RE-AIM Evaluation Framework: A Cluster-randomized Trial
- ClinicalTrials.gov ID
- NCT05696119
- Acronym / sponsor ID
- I-PROTECT / 2022-06148-02
- Conditions
- Athletic Injuries, Health Behavior
- Keywords
- Physical activity, Preventive therapy, Adolescent, Health plan implementation, Behaviour change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,225 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- 31 May 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 18 Oct 2024 (actual)
- First posted
- 25 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster-randomized study
| Arm | Type | Receives |
|---|---|---|
| I-PROTECT | Experimental | Behavioral: I-PROTECTI-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. |
| Control group | Active comparator | Behavioral: ControlCoaches 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I-PROTECTI-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. | Behavioural | I-PROTECT |
| ControlCoaches 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. | Behavioural | Control group |
Primary outcome
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).
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Implementation as measured by adherence
Time frame: 9-month follow-up
Adherence (frequency) of using intervention (players, coaches, club administrators)
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)
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)
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)
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)
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)
1 secondary outcome
Implementation determinants
Time frame: After follow-up, approx. 10 months after study start
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Results publication: PubMed 41496745Lucander 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.
- Results publication: PubMed 40640037Ageberg 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.
- Results publication: PubMed 40018138Ageberg 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.
- Ageberg et al. Implementing injury prevention training in youth handball (I-PROTECT) in Sweden: Study protocol for a cluster-randomized trialLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Ageberg, PhD principal investigator
Lund University
1 site in 1 country: see every site and its status.
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.