Athletic InjuriesI-PROTECTNCT04481958
Implementation of the I-PROTECT Model
A study testing I-PROTECT in people with Athletic Injuries, run by Lund University at 1 site in Sweden.
Trial summary
Evidence-based injury prevention training is highly effective in reducing sport-related musculoskeletal injuries in youth. However, this training has so far had limited public health impact because it is not widely or properly implemented or sustained. 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
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteSweden
- Study dates
- 27 Aug 2020to 24 Jan 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: Implementation of Injury Prevention Training and an Associated Implementation Strategy in Youth Handball: A Pilot Study of the I-PROTECT Model
Evidence-based injury prevention training is highly effective in reducing sport-related musculoskeletal injuries in youth. However, this training has so far had limited public health impact because it is not widely or properly implemented or sustained. In this single case study with youth teams from two handball clubs in Southern Sweden, the aim is to test the I-PROTECT model, featuring injury prevention training and an associated implementation plan. The main hypothesis is that the intervention will result in higher motivational and volitional levels in relation to injury prevention training.
Read the detailed description
This is a pilot study included in the "Implementing injury Prevention training ROutines in TEams and Clubs in youth Team handball (I-PROTECT)" project (Ageberg et al, 2019, 2020). 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 (Ageberg et al 2020). The current study is a prospective single case study for initial testing and evaluation of the I-PROTECT model (i.e., before the model is implemented in a larger scale study). The reporting will adhere to the SCRIBE guidelines. All youth teams in the two clubs with representatives of the stakeholder group overseeing the I-PROTECT project will use the I-PROTECT model for one handball season. The Health Action Process Approach (HAPA) theory will be used to evaluate behavior change among players, coaches and club administrators. The Reach, Effectiveness, Adoption, Implementation, and Maintenance Sport Setting Matrix (RE-AIM SSM) framework will be used to guide the evaluation of implementation outcomes of the I-PROTECT model among all stakeholders (players, coaches, club administrators, caregivers).
The main hypothesis is that the intervention increases scores in HAPA questions in coaches from pre- to post intervention by at least 30%, indicating higher motivational and volitional levels in relation to injury prevention training post intervention (end of season) compared to pre-intervention (baseline). A preliminary sample size calculation indicates that 42 coaches are needed to detect a clinically relevant change in behavior of at least 30% (baseline vs post intervention) with 80% power at the 5% significance level. Secondary outcomes will be: i) HAPA questions among players and club administrators; ii) RE-AIM SSM questions, descriptive data, and/or mobile application data among all stakeholders (players, coaches, club administrators, caregivers). Interviews (e.g., focus groups) with end-users will be conducted to enable an in-depth understanding of the feasibility, acceptability and usability of the program, including its packaging. An "exit strategy" will be employed to refine the model, address any potential barriers for implementation and sustainability, and embed the I-PROTECT model into the organizations that have participated in the study.
Due to pandemic restrictions, handball training was only performed as usual about 2 months at the start of the season, and evaluation of the I-PROTECT-model could not be conducted as planned. Nineteen teams with their coaches, players, and caregivers included (approx. 700 participants in total). The following data was collected:
- Main outcome: HAPA questions for coaches at baseline and at end-of-season
- Secondary outcomes: HAPA and RE-AIM questions caregivers at baseline
- Conditions
- Athletic Injuries
- Being tested
- I-PROTECT
- Keywords
- Physical activity, Preventive therapy, Adolescent, Health plan implementation, Behaviour change
- Medical subject headings
- Athletic Injuries, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-PROTECTBehavioural
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 (the I-PROTECT GO), including modules tailored for coaches, players, club administrators, and caregivers, respectively. Coaches are introduced to the intervention in a workshop, and they will conduct the exercises with their teams during handball practice. Due to pandemic restrictions, the mobile application could not be finalized, and only the module for coaches was available.
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Action Process Approach questions for coaches
An adapted version of the Health Action Process Approach (HAPA), specifically related to injury prevention training for youth team handball, has been developed and adapted for coaches. The questions focus on motivational strategies (e.g., risk perception, outcome expectancies) and volitional strategies (e.g., action planning, maintenance self-efficacy) for behavior change regarding injury-prevention training.
Measured: Baseline to end-of-season (after approx. 8 months)
Secondary outcomes (2)
Descriptive information about the Covid-19 pandemic and use of I-PROTECT (coaches)
Questions to coaches about use of I-PROTECT before and during pandemic restrictions
Measured: Baseline to end-of-season (after approx. 8 months)
Health Action Process Approach and Reach, Effectiveness, Adoption, Implementation, and Maintenance Sport Setting Matrix questions among caregivers
Health Action Process Approach (HAPA) and Reach, Effectiveness, Adoption, Implementation, and Maintenance Sport Setting Matrix (RE-AIM SSM), specifically related to injury prevention training for youth team handball, adapted for caregivers
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start27 Aug 2020
- Primary completion24 Jan 2022
- Study completion24 Jan 2022
Why it stopped: Due to Covid-19 restrictions, handball training was only performed about 2 months at the start of the season, and intervention and evaluation could not be conducted as planned.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Athletic InjuriesStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single case study, purposeful sampling
- Masking
- None (open label)
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Ageberg, Lund University
- Investigators
- Eva Ageberg, PhD, Principal investigator, Department of Health Sciences, Lund University, Lund, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04481958
- Sponsor's protocol ID
- 2014/713
- Acronym
- I-PROTECT
- Status last verified
- Jan 2022
- First submitted
- 8 Jul 2020
- Last updated
- 2 Feb 2022
- 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 32019772Ageberg E, Bunke S, Lucander K, Nilsen P, Donaldson A. Facilitators to support the implementation of injury prevention training in youth handball: A concept mapping approach. Scand J Med Sci Sports. 2019 Feb;29(2):275-285. doi: 10.1111/sms.13323. Epub 2018 Nov 8.
PubMed 30339309
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Injury Prevention Training and an Associated Implementation Strategy in Youth Handball: A Pilot Study of the I-PROTECT Model
- ClinicalTrials.gov ID
- NCT04481958
- Acronym / sponsor ID
- I-PROTECT / 2014/713
- Conditions
- Athletic Injuries
- Keywords
- Physical activity, Preventive therapy, Adolescent, Health plan implementation, Behaviour change
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to Covid-19 restrictions, handball training was only performed about 2 months at the start of the season, and intervention and evaluation could not be conducted as planned.
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- 27 Aug 2020 (actual)
- Primary completion
- 24 Jan 2022 (actual)
- Study completion
- 24 Jan 2022 (actual)
- First posted
- 22 Jul 2020 (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.
Evidence-based injury prevention training is highly effective in reducing sport-related musculoskeletal injuries in youth. However, this training has so far had limited public health impact because it is not widely or properly implemented or sustained. In this single case study with youth teams from two handball clubs in Southern Sweden, the aim is to test the I-PROTECT model, featuring injury prevention training and an associated implementation plan. The main hypothesis is that the intervention will result in higher motivational and volitional levels in relation to injury prevention training.
Detailed description
This is a pilot study included in the "Implementing injury Prevention training ROutines in TEams and Clubs in youth Team handball (I-PROTECT)" project (Ageberg et al, 2019, 2020). 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 (Ageberg et al 2020). The current study is a prospective single case study for initial testing and evaluation of the I-PROTECT model (i.e., before the model is implemented in a larger scale study). The reporting will adhere to the SCRIBE guidelines. All youth teams in the two clubs with representatives of the stakeholder group overseeing the I-PROTECT project will use the I-PROTECT model for one handball season. The Health Action Process Approach (HAPA) theory will be used to evaluate behavior change among players, coaches and club administrators. The Reach, Effectiveness, Adoption, Implementation, and Maintenance Sport Setting Matrix (RE-AIM SSM) framework will be used to guide the evaluation of implementation outcomes of the I-PROTECT model among all stakeholders (players, coaches, club administrators, caregivers).
The main hypothesis is that the intervention increases scores in HAPA questions in coaches from pre- to post intervention by at least 30%, indicating higher motivational and volitional levels in relation to injury prevention training post intervention (end of season) compared to pre-intervention (baseline). A preliminary sample size calculation indicates that 42 coaches are needed to detect a clinically relevant change in behavior of at least 30% (baseline vs post intervention) with 80% power at the 5% significance level. Secondary outcomes will be: i) HAPA questions among players and club administrators; ii) RE-AIM SSM questions, descriptive data, and/or mobile application data among all stakeholders (players, coaches, club administrators, caregivers). Interviews (e.g., focus groups) with end-users will be conducted to enable an in-depth understanding of the feasibility, acceptability and usability of the program, including its packaging. An "exit strategy" will be employed to refine the model, address any potential barriers for implementation and sustainability, and embed the I-PROTECT model into the organizations that have participated in the study.
Due to pandemic restrictions, handball training was only performed as usual about 2 months at the start of the season, and evaluation of the I-PROTECT-model could not be conducted as planned. Nineteen teams with their coaches, players, and caregivers included (approx. 700 participants in total). The following data was collected:
- Main outcome: HAPA questions for coaches at baseline and at end-of-season
- Secondary outcomes: HAPA and RE-AIM questions caregivers at baseline
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single case study, purposeful sampling
| Arm | Type | Receives |
|---|---|---|
| I-PROTECT model | Experimental | Behavioral: I-PROTECTThe 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. |
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-PROTECTThe 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 (the I-PROTECT GO), including modules tailored for coaches, players, club administrators, and caregivers, respectively. Coaches are introduced to the intervention in a workshop, and they will conduct the exercises with their teams during handball practice. Due to pandemic restrictions, the mobile application could not be finalized, and only the module for coaches was available. | Behavioural | I-PROTECT model |
Primary outcome
Health Action Process Approach questions for coaches
Time frame: Baseline to end-of-season (after approx. 8 months)
An adapted version of the Health Action Process Approach (HAPA), specifically related to injury prevention training for youth team handball, has been developed and adapted for coaches. The questions focus on motivational strategies (e.g., risk perception, outcome expectancies) and volitional strategies (e.g., action planning, maintenance self-efficacy) for behavior change regarding injury-prevention training.
2 secondary outcomes
Descriptive information about the Covid-19 pandemic and use of I-PROTECT (coaches)
Time frame: Baseline to end-of-season (after approx. 8 months)
Health Action Process Approach and Reach, Effectiveness, Adoption, Implementation, and Maintenance Sport Setting Matrix questions among caregivers
Time frame: Baseline
Results and safety
The study was stopped early (reason given: Due to Covid-19 restrictions, handball training was only performed about 2 months at the start of the season, and intervention and evaluation could not be conducted as planned.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
- 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.
- Background: PubMed 30339309Ageberg E, Bunke S, Lucander K, Nilsen P, Donaldson A. Facilitators to support the implementation of injury prevention training in youth handball: A concept mapping approach. Scand J Med Sci Sports. 2019 Feb;29(2):275-285. doi: 10.1111/sms.13323. Epub 2018 Nov 8.
- 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 principal investigator
Department of Health Sciences, Lund University, Lund, Sweden
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, 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: stopped early, as of the sponsor's last update on 2 Feb 2022. 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 was stopped early (reason given: Due to Covid-19 restrictions, handball training was only performed about 2 months at the start of the season, and intervention and evaluation could not be conducted as planned.). Results are not available in the source record.
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?
Health Action Process Approach questions for coaches (time frame: Baseline to end-of-season (after approx. 8 months)). 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 NCT04481958, which also lists 2 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 2 Feb 2022.