Athletic InjuriesI-PROTECTNCT05304507
Pilot Study of a Tailored Model for Implementation of Injury Prevention Training in Youth Handball (the I-PROTECT Model)
A study testing I-PROTECT model in people with Athletic Injuries, run by Lund University at 1 site in Sweden.
Trial summary
This pilot study aims to test a tailored model (the I-PROTECT model) for implementation of injury prevention training in youth handball compared with current practice. Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Athletic Injuries
- What is being tested?
- I-PROTECT model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 597 participants
- Where
- 1 siteSweden
- Study dates
- 7 Mar 2022to 31 Dec 2022
- 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 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Players: ages 13-17 years and training ≥2 times/week in a team
- Coaches: leading ≥1 training session/week
- Caregivers: directly associated with the eligible players
- Club administrators: engagement in the issues of sports injury, coach education or policy development for youth players
Who cannot join
- Employed/paid players
- Stakeholder other than the groups listed in inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tailored Model for Implementation of Injury Prevention Training in Youth Handball Compared With Current Practice: A Pilot Study of the I-PROTECT Model
This pilot study aims to test a tailored model (the I-PROTECT model) for implementation of injury prevention training in youth handball compared with current practice.
Read the detailed description
Injury prevention training is effective in reducing musculoskeletal injuries in youth athletes but has had limited public health impact because it is not widely or properly implemented. The lack of involving end-users at the individual and organizational levels is a main contributor to insufficient implementation.
This is a non-randomized pilot study included in the "Implementing injury Prevention training ROutines in TEams and Clubs in youth Team handball (I-PROTECT)" project. The overall aim of I-PROTECT is to achieve wide-spread, sustained and high-fidelity use of evidence-based injury prevention training in youth handball through behavior change at multiple levels within the sports delivery system (individual and organizational levels). The I-PROTECT model is evidence-based, theory-informed, and context-specific injury prevention training specifically tailored for youth handball players, incorporating physical and psychological components and an associated implementation strategy. The process of developing the I-PROTECT model has been described.
In a prospective single-case study (ClinicalTrials.gov registration number: NCT04481958), the I-PROTECT model was implemented and tested in all youth teams (n=19) of two clubs during the 2020/2021 handball season. Due to Covid pandemic restrictions, handball training was only performed for about 2 months, thus, affecting intervention implementation and data collection. To further evaluate, develop, and finalize the I-PROTECT model, we will in the current study conduct pilot testing in clubs not involved in developing the model, before testing the model in a larger scale study.
Two clubs in Sweden offering handball for youth players will be recruited by convenience sampling. One club will use the I-PROTECT model (experimental) and one club will use current practice (control). Intervention will be approx. 6 weeks. Data will be collected among stakeholders (players, coaches, club administrators, caregivers) before, during and after the intervention. Parametric, or non-parametric, tests will be used as appropriate for main and secondary outcomes. Data will be used to calculate sample size in the main outcome for a larger scale study as well as to assess implementation determinants.
- Conditions
- Athletic Injuries
- Being tested
- I-PROTECT model, Control group
- Medical subject headings
- Athletic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-PROTECT modelBehavioural
The I-PROTECT model 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 exercises based on physical and psychological principles of effective injury prevention training, specifically tailored for youth handball players, and support for developing a continuous implementation strategy. The intervention is delivered through a mobile application specifically developed for the I-PROTECT project (the I-PROTECT GO), including coach, player, club administrator, and caregiver modules. Coaches are introduced to the intervention in a workshop, and they will conduct the exercises with their teams during handball practice. Players will have support for conducting exercises on their own, and club administrators for developing an implementation strategy. Caregivers will have tailored information about injury prevention training.
Control groupBehavioural
Youth coaches in the control group club will be asked to use injury prevention training available in the coach education material ("Ready for handball"), i.e., current practice in Sweden.
| Study group | Role | What they receive |
|---|---|---|
| I-PROTECT model | Experimental | The I-PROTECT model is an end-user-driven intervention including evidence-based, theory-informed, and context-specific injury prevention training for youth handball, and an associated implementation strategy. Receives: Behavioral: I-PROTECT model |
| Control group | Active comparator | Youth coaches in the control group club will be asked to use injury prevention training available in the coach education material ("Ready for handball"), i.e., current practice in Sweden. Receives: Behavioral: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of injury prevention training
Frequency of injury prevention training on a team level, reported by coaches weekly (0, 1, 2, 3 or more session/week). Using injury prevention training for two session or more per week at regular handball training over the intervention period will signify that injury prevention is implemented in a team (binary outcome: ≥2 per week or <2 per week).
Measured: Study start up to end of study (6 weeks)
Secondary outcomes (3)
Adoption and fidelity (coaches)
Coaches' weekly report if they have followed the program as intended.
Measured: Study start up to end of study (6 weeks)
Implementation determinants
Questionnaire data for implementation determinants will be collected for coaches and caregivers. Questions aligned with the Health Action Process Approach (HAPA) theory and the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework will be adapted to each stakeholder group.
Measured: Baseline
Implementation determinants
Questionnaire or interview data for implementation determinants will be collected for all stakeholders (players, coaches, caregivers, club representatives). Questions aligned with the Health Action Process Approach (HAPA) theory and the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework will be adapted to each stakeholder group. Data will also be gathered (e.g., focus groups interviews) to enable an in-depth understanding of potential barriers and facilitators, acceptability, usability, and sustainability of the I-PROTECT model, including its packaging, and of potential barriers for filling in questionnaires.
Measured: After study end at approx. 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start7 Mar 2022
- Primary completion22 Jun 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Non-randomized pilot study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 597 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eva Ageberg, PhD, Prof, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05304507
- Sponsor's protocol ID
- 2020-02952
- Other IDs
- 2014/713
- Acronym
- I-PROTECT
- Status last verified
- Nov 2023
- First submitted
- 7 Mar 2022
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Share published data on reasonable request
Publications
Ageberg E, Bunke S, Nilsen P, Donaldson A. Planning injury prevention training for youth handball players: application of the generalisable six-step intervention development process. Inj Prev. 2020 Apr;26(2):164-169. doi: 10.1136/injuryprev-2019-043468. Epub 2020 Feb 4.
PubMed 32019772
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Model for Implementation of Injury Prevention Training in Youth Handball Compared With Current Practice: A Pilot Study of the I-PROTECT Model
- ClinicalTrials.gov ID
- NCT05304507
- Acronym / sponsor ID
- I-PROTECT / 2020-02952
- Conditions
- Athletic Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 597 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 22 Jun 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 31 Mar 2022 (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.
This pilot study aims to test a tailored model (the I-PROTECT model) for implementation of injury prevention training in youth handball compared with current practice.
Detailed description
Injury prevention training is effective in reducing musculoskeletal injuries in youth athletes but has had limited public health impact because it is not widely or properly implemented. The lack of involving end-users at the individual and organizational levels is a main contributor to insufficient implementation.
This is a non-randomized pilot study included in the "Implementing injury Prevention training ROutines in TEams and Clubs in youth Team handball (I-PROTECT)" project. The overall aim of I-PROTECT is to achieve wide-spread, sustained and high-fidelity use of evidence-based injury prevention training in youth handball through behavior change at multiple levels within the sports delivery system (individual and organizational levels). The I-PROTECT model is evidence-based, theory-informed, and context-specific injury prevention training specifically tailored for youth handball players, incorporating physical and psychological components and an associated implementation strategy. The process of developing the I-PROTECT model has been described.
In a prospective single-case study (ClinicalTrials.gov registration number: NCT04481958), the I-PROTECT model was implemented and tested in all youth teams (n=19) of two clubs during the 2020/2021 handball season. Due to Covid pandemic restrictions, handball training was only performed for about 2 months, thus, affecting intervention implementation and data collection. To further evaluate, develop, and finalize the I-PROTECT model, we will in the current study conduct pilot testing in clubs not involved in developing the model, before testing the model in a larger scale study.
Two clubs in Sweden offering handball for youth players will be recruited by convenience sampling. One club will use the I-PROTECT model (experimental) and one club will use current practice (control). Intervention will be approx. 6 weeks. Data will be collected among stakeholders (players, coaches, club administrators, caregivers) before, during and after the intervention. Parametric, or non-parametric, tests will be used as appropriate for main and secondary outcomes. Data will be used to calculate sample size in the main outcome for a larger scale study as well as to assess implementation determinants.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Non-randomized pilot study
| Arm | Type | Receives |
|---|---|---|
| I-PROTECT model | Experimental | Behavioral: I-PROTECT modelThe I-PROTECT model is an end-user-driven intervention including evidence-based, theory-informed, and context-specific injury prevention training for youth handball, and an associated implementation strategy. |
| Control group | Active comparator | Behavioral: Control groupYouth coaches in the control group club will be asked to use injury prevention training available in the coach education material ("Ready for handball"), i.e., current practice in Sweden. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Players: ages 13-17 years and training ≥2 times/week in a team
- Coaches: leading ≥1 training session/week
- Caregivers: directly associated with the eligible players
- Club administrators: engagement in the issues of sports injury, coach education or policy development for youth players
Key exclusion criteria (2 listed)
- Employed/paid players
- Stakeholder other than the groups listed in inclusion criteria
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-PROTECT modelThe I-PROTECT model 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 exercises based on physical and psychological principles of effective injury prevention training, specifically tailored for youth handball players, and support for developing a continuous implementation strategy. The intervention is delivered through a mobile application specifically developed for the I-PROTECT project (the I-PROTECT GO), including coach, player, club administrator, and caregiver modules. Coaches are introduced to the intervention in a workshop, and they will conduct the exercises with their teams during handball practice. Players will have support for conducting exercises on their own, and club administrators for developing an implementation strategy. Caregivers will have tailored information about injury prevention training. | Behavioural | I-PROTECT model |
| Control groupYouth coaches in the control group club will be asked to use injury prevention training available in the coach education material ("Ready for handball"), i.e., current practice in Sweden. | Behavioural | Control group |
Primary outcome
Frequency of injury prevention training
Time frame: Study start up to end of study (6 weeks)
Frequency of injury prevention training on a team level, reported by coaches weekly (0, 1, 2, 3 or more session/week). Using injury prevention training for two session or more per week at regular handball training over the intervention period will signify that injury prevention is implemented in a team (binary outcome: ≥2 per week or <2 per week).
3 secondary outcomes
Adoption and fidelity (coaches)
Time frame: Study start up to end of study (6 weeks)
Implementation determinants
Time frame: Baseline
Implementation determinants
Time frame: After study end at approx. 6 weeks
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 29 Nov 2023.
- Background: PubMed 32019772Ageberg E, Bunke S, Nilsen P, Donaldson A. Planning injury prevention training for youth handball players: application of the generalisable six-step intervention development process. Inj Prev. 2020 Apr;26(2):164-169. doi: 10.1136/injuryprev-2019-043468. Epub 2020 Feb 4.
- Individual participant dataSharing planned: Undecided. Share published data on reasonable request
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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, Prof 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 model in people with Athletic Injuries, 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 4 inclusion and 2 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 29 Nov 2023. 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?
Frequency of injury prevention training (time frame: Study start up to end of study (6 weeks)). 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 NCT05304507, which also lists 1 linked publication.
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 29 Nov 2023.