Clinical trial NCT05358990: Knowledge Mobilization Activities to Support Decision-Making by Youth, Parents and Adults: Study Protocol
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Keywords: electronic Coronavirus Disease Recommendation Map (eCOVID RecMap)
Plain Language Recommendation
Standard Language Versions
Public Engagement
Knowledge Mobilization
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Western University
name: The Hospital for Sick Children
name: University of Alberta
First posted: 2022-05-03
Enrollment: 997
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

Eligibility criteria: 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

Primary outcomes:
measure: Understanding with Multiple Choice Questions
timeFrame: Duration of survey (approximately 25 minutes) at baseline
Secondary outcomes:
measure: Accessibility and Usability on a Seven-Point Likert Scale
timeFrame: Duration of survey (approximately 25 minutes) at baseline
measure: Satisfaction on a Seven-Point Likert Scale
timeFrame: Duration of survey (approximately 25 minutes) at baseline
measure: Intended Behavior on a Seven-Point Likert Scale and Multiple Choice Questions
timeFrame: Duration of survey (approximately 25 minutes) at baseline
measure: Preference on a Seven-Point Likert-Scale
timeFrame: Duration of survey (approximately 25 minutes) at baseline
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Holger J Schunemann, MD, PHD
role: STUDY_CHAIR
affiliation: Western University
name: Kevin Pottie
role: PRINCIPAL_INVESTIGATOR
affiliation: The Hospital for Sick Children Research Institute
name: Martin Offringa
role: PRINCIPAL_INVESTIGATOR
affiliation: The Hospital for Sick Children Research Institute
name: Nancy Butcher
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta
name: Lisa Hartling
role: PRINCIPAL_INVESTIGATOR
References: