<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04481958</url>
  </required_header>
  <id_info>
    <org_study_id>2014/713</org_study_id>
    <nct_id>NCT04481958</nct_id>
  </id_info>
  <brief_title>Implementation of the I-PROTECT Model</brief_title>
  <acronym>I-PROTECT</acronym>
  <official_title>Implementation of Injury Prevention Training and an Associated Implementation Strategy in Youth Handball: A Pilot Study of the I-PROTECT Model</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lund University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lund University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evidence-based injury prevention training is highly effective in reducing sport-related&#xD;
      musculoskeletal injuries in youth. However, this training has so far had limited public&#xD;
      health impact because it is not widely or properly implemented or sustained. In this single&#xD;
      case study with youth teams from two handball clubs in Southern Sweden, the aim is to test&#xD;
      the I-PROTECT model, featuring injury prevention training and an associated implementation&#xD;
      plan. The main hypothesis is that the intervention will result in higher motivational and&#xD;
      volitional levels in relation to injury prevention training.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a pilot study included in the &quot;Implementing injury Prevention training ROutines in&#xD;
      TEams and Clubs in youth Team handball (I-PROTECT)&quot; project (Ageberg et al, 2019, 2020). The&#xD;
      overall aim of I-PROTECT is to achieve wide-spread, sustained and high-fidelity use of&#xD;
      evidence-based injury prevention training in youth handball through behavior change at&#xD;
      multiple levels within the sports delivery system (individual and organizational levels). The&#xD;
      I-PROTECT model is evidence-based, theory-informed, and context-specific injury prevention&#xD;
      training specifically tailored for youth handball players, incorporating physical and&#xD;
      psychological components and an associated implementation strategy. The process of developing&#xD;
      the I-PROTECT model has been described (Ageberg et al 2020). The current study is a&#xD;
      prospective single case study for initial testing and evaluation of the I-PROTECT model&#xD;
      (i.e., before the model is implemented in a larger scale study). The reporting will adhere to&#xD;
      the SCRIBE guidelines. All youth teams in the two clubs with representatives of the&#xD;
      stakeholder group overseeing the I-PROTECT project will use the I-PROTECT model for one&#xD;
      handball season. The Health Action Process Approach (HAPA) theory will be used to evaluate&#xD;
      behavior change among players, coaches and club administrators. The Reach, Effectiveness,&#xD;
      Adoption, Implementation, and Maintenance Sport Setting Matrix (RE-AIM SSM) framework will be&#xD;
      used to guide the evaluation of implementation outcomes of the I-PROTECT model among all&#xD;
      stakeholders (players, coaches, club administrators, caregivers).&#xD;
&#xD;
      The main hypothesis is that the intervention increases scores in HAPA questions in coaches&#xD;
      from pre- to post intervention by at least 30%, indicating higher motivational and volitional&#xD;
      levels in relation to injury prevention training post intervention (end of season) compared&#xD;
      to pre-intervention (baseline). A preliminary sample size calculation indicates that 42&#xD;
      coaches are needed to detect a clinically relevant change in behavior of at least 30%&#xD;
      (baseline vs post intervention) with 80% power at the 5% significance level. Secondary&#xD;
      outcomes will be: i) HAPA questions among players and club administrators; ii) RE-AIM SSM&#xD;
      questions, descriptive data, and/or mobile application data among all stakeholders (players,&#xD;
      coaches, club administrators, caregivers). Interviews (e.g., focus groups) with end-users&#xD;
      will be conducted to enable an in-depth understanding of the feasibility, acceptability and&#xD;
      usability of the program, including its packaging. An &quot;exit strategy&quot; will be employed to&#xD;
      refine the model, address any potential barriers for implementation and sustainability, and&#xD;
      embed the I-PROTECT model into the organizations that have participated in the study.&#xD;
&#xD;
      Due to pandemic restrictions, handball training was only performed as usual about 2 months at&#xD;
      the start of the season, and evaluation of the I-PROTECT-model could not be conducted as&#xD;
      planned. Nineteen teams with their coaches, players, and caregivers included (approx. 700&#xD;
      participants in total). The following data was collected:&#xD;
&#xD;
        -  Main outcome: HAPA questions for coaches at baseline and at end-of-season&#xD;
&#xD;
        -  Secondary outcomes: HAPA and RE-AIM questions caregivers at baseline&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Due to Covid-19 restrictions, handball training was only performed about 2 months at the start&#xD;
    of the season, and intervention and evaluation could not be conducted as planned.&#xD;
  </why_stopped>
  <start_date type="Actual">August 27, 2020</start_date>
  <completion_date type="Actual">January 24, 2022</completion_date>
  <primary_completion_date type="Actual">January 24, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Single case study, purposeful sampling</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Health Action Process Approach questions for coaches</measure>
    <time_frame>Baseline to end-of-season (after approx. 8 months)</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Descriptive information about the Covid-19 pandemic and use of I-PROTECT (coaches)</measure>
    <time_frame>Baseline to end-of-season (after approx. 8 months)</time_frame>
    <description>Questions to coaches about use of I-PROTECT before and during pandemic restrictions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Action Process Approach and Reach, Effectiveness, Adoption, Implementation, and Maintenance Sport Setting Matrix questions among caregivers</measure>
    <time_frame>Baseline</time_frame>
    <description>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</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">700</enrollment>
  <condition>Athletic Injuries</condition>
  <arm_group>
    <arm_group_label>I-PROTECT model</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>I-PROTECT</intervention_name>
    <description>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.</description>
    <arm_group_label>I-PROTECT model</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Stakeholders (players, coaches, caregivers, club administrators) of all youth teams (13-17&#xD;
        years) in two community handball clubs will be eligible for participation.&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Players: ages 13-17 years and training ≥2 times/week in a team&#xD;
&#xD;
          -  Coaches: leading ≥1 training session/week&#xD;
&#xD;
          -  Caregivers: directly associated with the eligible players&#xD;
&#xD;
          -  Club administrators: engagement in the issues of sports injury, coach education - or&#xD;
             policy development for youth players&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Employed/paid players&#xD;
&#xD;
          -  Stakeholder other than the groups listed in inclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eva Ageberg, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Health Sciences, Lund University, Lund, Sweden</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Eva Ageberg</name>
      <address>
        <city>Lund</city>
        <zip>22100</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>32019772</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>30339309</PMID>
  </reference>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>January 24, 2022</last_update_submitted>
  <last_update_submitted_qc>January 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lund University</investigator_affiliation>
    <investigator_full_name>Eva Ageberg</investigator_full_name>
    <investigator_title>PhD, Professor</investigator_title>
  </responsible_party>
  <keyword>Physical activity</keyword>
  <keyword>Preventive therapy</keyword>
  <keyword>Adolescent</keyword>
  <keyword>Health plan implementation</keyword>
  <keyword>Behaviour change</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Athletic Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Share published data on reasonable request.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04481958
org study id: 2014/713
nct id: NCT04481958
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Single case study, purposeful sampling
primary purpose: Prevention
masking: None (Open Label)
measure: Health Action Process Approach questions for coaches
time frame: Baseline to end-of-season (after approx. 8 months)
description: 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.
measure: Descriptive information about the Covid-19 pandemic and use of I-PROTECT (coaches)
time frame: Baseline to end-of-season (after approx. 8 months)
description: Questions to coaches about use of I-PROTECT before and during pandemic restrictions
measure: Health Action Process Approach and Reach, Effectiveness, Adoption, Implementation, and Maintenance Sport Setting Matrix questions among caregivers
time frame: Baseline
description: 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
arm group label: I-PROTECT model
arm group type: Experimental
description: 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.
intervention type: Behavioral
intervention name: I-PROTECT
description: 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.
arm group label: I-PROTECT model
criteria: 
gender: All
minimum age: 13 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Eva Ageberg, PhD
role: Principal Investigator
affiliation: Department of Health Sciences, Lund University, Lund, Sweden
facility: 
country: Sweden
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.
PMID: 32019772
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.
PMID: 30339309
responsible party type: Principal Investigator
investigator affiliation: Lund University
investigator full name: Eva Ageberg
investigator title: PhD, Professor
mesh term: Athletic Injuries
sharing ipd: Undecided
ipd description: Share published data on reasonable request.