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

Health Behavior Clinical Trial

— I-PROTECT  

Official title:

Implementing Injury Prevention Training in Youth Handball (I-PROTECT) Using the RE-AIM Evaluation Framework: A Cluster-randomized Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05696119
• Other study ID #: 2022-06148-02
• Secondary ID: 2014/713
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 31, 2023
• Est. completion date: July 2024

Study information

• Verified date: April 2024
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3500
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

Stakeholders (players, coaches, caregivers, club administrators) of all youth teams in randomly selected community handball clubs will be eligible for participation.

Inclusion Criteria:

• 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

• Caregivers: directly associated with the eligible players

• Club administrators: engaged in the issues of sports injury, coach education or policy development for youth players

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Athletic Injuries
• Health Behavior
• Wounds and Injuries

Intervention

Behavioral:
• I-PROTECT
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.
• Control
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.

Locations

Country	Name	City	State
Sweden	Eva Ageberg	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Lund University

Country where clinical trial is conducted

Sweden, 

References & Publications (5)

Ageberg E, Brodin EM, Linnell J, Moesch K, Donaldson A, Adebo E, Benjaminse A, Ekengren J, Graner S, Johnson U, Lucander K, Myklebust G, Moller M, Tranaeus U, Bunke S. Cocreating injury prevention training for youth team handball: bridging theory and practice. BMJ Open Sport Exerc Med. 2022 Apr 4;8(2):e001263. doi: 10.1136/bmjsem-2021-001263. eCollection 2022. — View Citation

Ageberg E, Bunke S, Linnell J, Moesch K. Co-creating holistic injury prevention training for youth handball: Development of an intervention targeting end-users at the individual, team, and organizational levels. BMC Sports Sci Med Rehabil. 2024 Jan 8;16(1):10. doi: 10.1186/s13102-023-00800-6. — View Citation

Ageberg 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. — View Citation

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. — View Citation

Moesch K, Bunke S, Linnell J, Brodin EM, Donaldson A, Ageberg E. "Yeah, I Mean, You're Going to Handball, so You Want to Use Balls as Much as Possible at Training": End-Users' Perspectives of Injury Prevention Training for Youth Handball Players. Int J Environ Res Public Health. 2022 Mar 14;19(6):3402. doi: 10.3390/ijerph19063402. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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)	9-month follow-up
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Implementation as measured by adherence	Adherence (frequency) of using intervention (players, coaches, club administrators)	9-month follow-up
Primary	Implementation as measured by fidelity to program	Fidelity to program, i.e. the proportion and type of exercises (players, coaches)	9-month follow-up
Primary	Implementation as measured by fidelity to implementation checklist	Fidelity to implementation checklist, i.e. proportion of use (club administrators)	9-month follow-up
Primary	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
Primary	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
Primary	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
Secondary	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