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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04992702
Other study ID # 1521444-1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2019
Est. completion date June 1, 2020

Study information

Verified date July 2021
Source Michigan Technological University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to evaluate the effects of a brief web-based educational intervention on improving Anterior Cruciate Ligament (ACL) injury prevention comprehension and implementation feasibility among coaches of athletes participating in landing and cutting sports (e.g., soccer, basketball, football, etc.). The two main hypotheses are that, compared to both an active and placebo control group, the brief animated video will produce greater improvements in: 1. Overall comprehension of ACL injury risk and mitigation: placebo control group < active control group < intervention group. 2. Feasibility of utilizing ACL injury prevention strategies: placebo control group < active control group < intervention group. Exploratory hypothesis: The brief animated video will produce greater improvements in various subcomponents of comprehension-specifically: basic ACL knowledge, risk knowledge, prevention knowledge and severity knowledge compared to both active and placebo control group conditions.


Description:

This study is a computer-based, three-arm pre-post randomized control design trial. Participants were randomized into an intervention group, active control group or passive control group on a 1:1:1 ratio by a computer-generated algorithm embedded within the Qualtrics software (Qualtrics, Provo, UT). Sports coaches of youth and adolescent athletes in various landing and cutting sports (e.g., soccer, basketball, volleyball, etc.) in the United States were recruited and invited through Qualtrics' panelists. The intervention group was shown a three-minute animated video consisting of various information components aimed at improving capability, motivation and opportunity to implement ACL injury prevention strategies. The active control group received commonly accessed information from a WebMD web-based article on ACL injury prevention. The placebo control group intervention received an educational video from the CDC about concussions that is comparable in duration to that of the ACL video. Overall ACL comprehension-composed of basic ACL knowledge, risk knowledge, prevention knowledge, and severity knowledge-as well as implementation feasibility were all measured prior to and immediately following the interventions.


Recruitment information / eligibility

Status Completed
Enrollment 479
Est. completion date June 1, 2020
Est. primary completion date June 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Sports coaches of youth and adolescent athletes in various landing and cutting sports (e.g., soccer, basketball, volleyball, etc.) in the United States. Exclusion Criteria: - Non sport coach or coach of non-landing and cutting sport (e.g., golf, swimming).

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Animated Video
Animated video to improve learning and motivation

Locations

Country Name City State
United States Michigan Technological University Houghton Michigan

Sponsors (1)

Lead Sponsor Collaborator
Michigan Technological University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall anterior cruciate ligament injury comprehension percent correct Items that measure ACL knowledge were gathered from peer reviewed, published articles. The scale consisted of 15 multiple choice items that assessed individuals knowledge about diverse issues with ACL injury such as risk, prevention, and consequences of the injury. Immediately following intervention
Secondary Average implementation feasibility measured by the feasibility of the intervention scale The feasibility of the intervention measure was used to assess the likelihood that the coach would successfully implement evidence-based prevention strategies. The 4 items consisted of the root phrase: "An ACL injury prevention program seems" followed by (1) implementable, (2) possible, (3) doable and (4) easy to use. The items were rated on a 5-point Likert scale ranging from completely disagree to completely agree. The average of the 4 items was used for the analysis. Immediately following intervention
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