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Clinical Trials/NCT05358990
NCT05358990CompletedNot Applicable

Knowledge Mobilization Activities to Support Decision-making by Youth, Parents and Adults Using a Systematic and Living Map of Evidence and Recommendations on Coronavirus Disease (COVID-19)

McMaster University2 sites in 1 country997 target enrollmentStarted: May 25, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
997
Locations
2
Primary Endpoint
Understanding with Multiple Choice Questions

Study Overview

Brief Summary

Coronavirus Disease (COVID-19) recommendations are usually developed for healthcare professionals (for example Doctors, health organizations, etc.). It is important to make sure that these recommendations can be used and understood by everyone. This study aims to make COVID-19 recommendations more accessible and understandable for parents and caregivers, adults, and youth.

Detailed Description

This is a two-arm superiority randomized controlled trial. The primary objective is to compare the understanding of key guideline information between the Plain Language Recommendation (PLR) (intervention) and the Standard Language Version (SLV- original recommendation as available in the published guideline) (comparison). Secondary outcomes include accessibility and usability of the information, satisfaction with the presentation, intended behavior to follow the information in the recommendation, and preference toward one of the two presentations. Recruitment will be global for the three populations (youth, parents, and adults), using three different online links. Data will be collected using a survey with 1:1 randomization to the intervention and subsequent demographic questions. Superiority will be declared if a minimal difference of 10% in understanding is achieved between the two groups (an average difference of 1 correct answer).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
15 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • For youth population: be between the ages of 15 to 24 years
  • For parents population: be 18 years and above and making decisions with or for their children (parent, caregiver, the legal guardian of a child < 18 years)
  • For adults: be 21 years of age or older
  • Need to be able to complete the survey in English

Exclusion Criteria

  • Individuals not fitting any of the above age categories or language requirement

Outcomes

Primary Outcomes

Understanding with Multiple Choice Questions

Time Frame: Duration of survey (approximately 25 minutes) at baseline

The primary outcome is understanding. Understanding is defined as the correct comprehension of key guideline content (year of publication, intent of the recommendation, direction of recommendation, etc.). This outcome will be measured with seven multiple-choice questions about key concepts in the recommendation with four to six response options for each question and only one correct answer (total minimum score of 0, maximum score of 7).

Secondary Outcomes

  • Satisfaction on a Seven-Point Likert Scale(Duration of survey (approximately 25 minutes) at baseline)
  • Preference on a Seven-Point Likert-Scale(Duration of survey (approximately 25 minutes) at baseline)
  • Accessibility and Usability on a Seven-Point Likert Scale(Duration of survey (approximately 25 minutes) at baseline)
  • Intended Behavior on a Seven-Point Likert Scale and Multiple Choice Questions(Duration of survey (approximately 25 minutes) at baseline)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Holger Schunemann

Professor

McMaster University

Study Sites (2)

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