Clinical trial NCT05696119: Implementing Injury Prevention Training in Youth Handball (I-PROTECT) Using the RE-AIM Evaluation Framework
Official title: Implementing Injury Prevention Training in Youth Handball (I-PROTECT) Using the RE-AIM Evaluation Framework: A Cluster-randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Athletic Injuries
Health Behavior
Keywords: Physical activity
Preventive therapy
Adolescent
Health plan implementation
Behaviour change
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 4225
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster-randomized study
Primary purpose: PREVENTION

Brief 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.

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).

Eligibility criteria: 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
* 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

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

Primary outcomes:
measure: Reach as measured by absolute number and proportion of individuals who participate
timeFrame: 9-month follow-up
measure: Effectiveness as measured by risk perception
timeFrame: 9-month follow-up
measure: Effectiveness as measured by outcome expectancies
timeFrame: 9-month follow-up
measure: Effectiveness as measured by perceived effectiveness
timeFrame: 9-month follow-up
measure: Adoption as measured by use
timeFrame: 9-month follow-up
measure: Adoption as measured by affective attitude
timeFrame: 9-month follow-up
measure: Adoption as measured by intervention coherence
timeFrame: 9-month follow-up
measure: Adoption as measured by self-efficacy
timeFrame: 9-month follow-up
measure: Adoption as measured by burden
timeFrame: 9-month follow-up
measure: Adoption as measured by opportunity costs
timeFrame: 9-month follow-up
measure: Adoption as measured by ease of use
timeFrame: 9-month follow-up
measure: Implementation as measured by adherence
timeFrame: 9-month follow-up
measure: Implementation as measured by fidelity to program
timeFrame: 9-month follow-up
measure: Implementation as measured by fidelity to implementation checklist
timeFrame: 9-month follow-up
measure: Implementation as measured by coping planning
timeFrame: 9-month follow-up
measure: Maintenance as measured by intention
timeFrame: 9-month follow-up
measure: Maintenance intention as measured by self-efficacy
timeFrame: 9-month follow-up
Secondary outcomes:
measure: Implementation determinants
timeFrame: After follow-up, approx. 10 months after study start
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Eva Ageberg
Study officials:
affiliation: Lund University
name: Eva Ageberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: