NCT05358990

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
997

participants targeted

Target at P75+ for not_applicable covid19

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 3, 2022

Completed
22 days until next milestone

Study Start

First participant enrolled

May 25, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2022

Completed
Last Updated

December 14, 2022

Status Verified

December 1, 2022

Enrollment Period

5 months

First QC Date

April 28, 2022

Last Update Submit

December 12, 2022

Conditions

Keywords

electronic Coronavirus Disease Recommendation Map (eCOVID RecMap)Plain Language RecommendationStandard Language VersionsPublic EngagementKnowledge Mobilization

Outcome Measures

Primary Outcomes (1)

  • Understanding with Multiple Choice Questions

    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).

    Duration of survey (approximately 25 minutes) at baseline

Secondary Outcomes (4)

  • Accessibility and Usability on a Seven-Point Likert Scale

    Duration of survey (approximately 25 minutes) at baseline

  • Satisfaction 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

  • Preference on a Seven-Point Likert-Scale

    Duration of survey (approximately 25 minutes) at baseline

Study Arms (2)

Plain Language Recommendation (PLR)

EXPERIMENTAL

New easy to read COVID-19 recommendations available on the COVID19 Living Map of Recommendations and Gateway to Contextualization (RecMap).

Other: Plain Language Recommendation (PLR)

Standard Language Version (SLV)

ACTIVE COMPARATOR

Original recommendation as initially published by the guideline organization.

Other: Standard Language Version (SLV)

Interventions

New easy to read COVID-19 recommendations available on the COVID19 Living Map of Recommendations and Gateway to Contextualization (RecMap).

Plain Language Recommendation (PLR)

Original recommendation as initially published by the guideline organization.

Standard Language Version (SLV)

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

Location

Related Publications (3)

  • Stallwood L, Sammy A, Prebeg M, Relihan J, Baba A, Charide R, Sayfi S, Elliott SA, Hartling L, Munan M, Richards DP, Mathew JL, Kredo T, Mbuagbaw L, Motilall A, Scott SD, Klugar M, Lotfi T, Stevens AL, Pottie K, Schunemann HJ, Butcher NJ, Offringa M; RecMap Members. Plain Language vs Standard Format for Youth Understanding of COVID-19 Recommendations: A Randomized Clinical Trial. JAMA Pediatr. 2023 Sep 1;177(9):956-965. doi: 10.1001/jamapediatrics.2023.2686.

  • Elliott SA, Scott SD, Charide R, Patterson-Stallwood L, Sayfi S, Motilall A, Baba A, Lotfi T, Suvada J, Klugar M, Kredo T, Mathew JL, Richards DP, Butcher NJ, Offringa M, Pottie K, Schunemann HJ, Hartling L. A multimethods randomized trial found that plain language versions improved parents' understanding of health recommendations. J Clin Epidemiol. 2023 Sep;161:8-19. doi: 10.1016/j.jclinepi.2023.06.018. Epub 2023 Jul 6.

  • Charide R, Stallwood L, Munan M, Sayfi S, Hartling L, Butcher NJ, Offringa M, Elliott S, Richards DP, Mathew JL, Akl EA, Kredo T, Mbuagbaw L, Motillal A, Baba A, Prebeg M, Relihan J, Scott SD, Suvada J, Falavigna M, Klugar M, Lotfi T, Stevens A, Pottie K, Schunemann HJ. Knowledge mobilization activities to support decision-making by youth, parents, and adults using a systematic and living map of evidence and recommendations on COVID-19: protocol for three randomized controlled trials and qualitative user-experience studies. Trials. 2023 Jan 14;24(1):27. doi: 10.1186/s13063-023-07067-9.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Holger J Schunemann, MD, PHD

    McMaster University

    STUDY CHAIR
  • Kevin Pottie

    Western University

    PRINCIPAL INVESTIGATOR
  • Martin Offringa

    The Hospital for Sick Children Research Institute

    PRINCIPAL INVESTIGATOR
  • Nancy Butcher

    The Hospital for Sick Children Research Institute

    PRINCIPAL INVESTIGATOR
  • Lisa Hartling

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 28, 2022

First Posted

May 3, 2022

Study Start

May 25, 2022

Primary Completion

October 25, 2022

Study Completion

October 25, 2022

Last Updated

December 14, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations