Implementing Injury Prevention Training in Youth Handball (I-PROTECT) Using the RE-AIM Evaluation Framework: A Cluster-randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,225
- 试验地点
- 2
- 主要终点
- Implementation as measured by adherence
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
An independent statistician, blinded to group allocation, will analyze data
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
I-PROTECT
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.
干预措施: I-PROTECT (Behavioral)
Control group
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.
干预措施: Control (Behavioral)
结局指标
主要结局
Implementation as measured by adherence
时间窗: 9-month follow-up
Adherence (frequency) of using intervention (players, coaches, club administrators)
Effectiveness as measured by risk perception
时间窗: 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
时间窗: 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
时间窗: 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 affective attitude
时间窗: 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 ease of use
时间窗: 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)
Adoption as measured by intervention coherence
时间窗: 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 burden
时间窗: 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
时间窗: 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)
Implementation as measured by fidelity to program
时间窗: 9-month follow-up
Fidelity to program, i.e. the proportion and type of exercises (players, coaches)
Reach as measured by absolute number and proportion of individuals who participate
时间窗: 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).
Adoption as measured by self-efficacy
时间窗: 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 use
时间窗: 9-month follow-up
Adoption is measured as having used any components and/or exercises (yes/no) (players, coaches, club administrators)
Implementation as measured by fidelity to implementation checklist
时间窗: 9-month follow-up
Fidelity to implementation checklist, i.e. proportion of use (club administrators)
Implementation as measured by coping planning
时间窗: 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
时间窗: 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
时间窗: 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)
次要结局
- Implementation determinants(After follow-up, approx. 10 months after study start)