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Implementation of the I-PROTECT Model (I-PROTECT)

Primary Purpose

Athletic Injuries

Status
Terminated
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
I-PROTECT
Sponsored by
Lund University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Athletic Injuries focused on measuring Physical activity, Preventive therapy, Adolescent, Health plan implementation, Behaviour change

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Stakeholders (players, coaches, caregivers, club administrators) of all youth teams (13-17 years) in two community handball clubs will be eligible for participation.

Inclusion Criteria:

  • 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

Exclusion Criteria

  • Employed/paid players
  • Stakeholder other than the groups listed in inclusion criteria

Sites / Locations

  • Eva Ageberg

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

I-PROTECT model

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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

Full Information

First Posted
July 8, 2020
Last Updated
January 24, 2022
Sponsor
Lund University
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1. Study Identification

Unique Protocol Identification Number
NCT04481958
Brief Title
Implementation of the I-PROTECT Model
Acronym
I-PROTECT
Official Title
Implementation of Injury Prevention Training and an Associated Implementation Strategy in Youth Handball: A Pilot Study of the I-PROTECT Model
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Terminated
Why 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.
Study Start Date
August 27, 2020 (Actual)
Primary Completion Date
January 24, 2022 (Actual)
Study Completion Date
January 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lund University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Athletic Injuries
Keywords
Physical activity, Preventive therapy, Adolescent, Health plan implementation, Behaviour change

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single case study, purposeful sampling
Masking
None (Open Label)
Allocation
N/A
Enrollment
700 (Actual)

8. Arms, Groups, and Interventions

Arm Title
I-PROTECT model
Arm Type
Experimental
Arm 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(s)
I-PROTECT
Intervention 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.
Primary Outcome Measure Information:
Title
Health Action Process Approach questions for coaches
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.
Time Frame
Baseline to end-of-season (after approx. 8 months)
Secondary Outcome Measure Information:
Title
Descriptive information about the Covid-19 pandemic and use of I-PROTECT (coaches)
Description
Questions to coaches about use of I-PROTECT before and during pandemic restrictions
Time Frame
Baseline to end-of-season (after approx. 8 months)
Title
Health Action Process Approach and Reach, Effectiveness, Adoption, Implementation, and Maintenance Sport Setting Matrix questions among caregivers
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
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Stakeholders (players, coaches, caregivers, club administrators) of all youth teams (13-17 years) in two community handball clubs will be eligible for participation. Inclusion Criteria: 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 Exclusion Criteria Employed/paid players Stakeholder other than the groups listed in inclusion criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Ageberg, PhD
Organizational Affiliation
Department of Health Sciences, Lund University, Lund, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eva Ageberg
City
Lund
ZIP/Postal Code
22100
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Share published data on reasonable request.
Citations:
PubMed Identifier
32019772
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.
Results Reference
background
PubMed Identifier
30339309
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.
Results Reference
background

Learn more about this trial

Implementation of the I-PROTECT Model

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