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Knowledge Mobilization Activities to Support Decision-Making by Youth, Parents and Adults: Study Protocol

NCT ID: NCT05358990

Last Updated: 2022-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

997 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-25

Study Completion Date

2022-10-25

Brief Summary

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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

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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).

Conditions

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COVID-19

Keywords

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electronic Coronavirus Disease Recommendation Map (eCOVID RecMap) Plain Language Recommendation Standard Language Versions Public Engagement Knowledge Mobilization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Plain Language Recommendation (PLR)

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

Group Type EXPERIMENTAL

Plain Language Recommendation (PLR)

Intervention Type OTHER

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

Standard Language Version (SLV)

Original recommendation as initially published by the guideline organization.

Group Type ACTIVE_COMPARATOR

Standard Language Version (SLV)

Intervention Type OTHER

Original recommendation as initially published by the guideline organization.

Interventions

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Plain Language Recommendation (PLR)

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

Intervention Type OTHER

Standard Language Version (SLV)

Original recommendation as initially published by the guideline organization.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Western University

OTHER

Sponsor Role collaborator

The Hospital for Sick Children

OTHER

Sponsor Role collaborator

University of Alberta

OTHER

Sponsor Role collaborator

McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Holger Schunemann

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Holger J Schunemann, MD, PHD

Role: STUDY_CHAIR

McMaster University

Kevin Pottie

Role: PRINCIPAL_INVESTIGATOR

Western University

Martin Offringa

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children Research Institute

Nancy Butcher

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children Research Institute

Lisa Hartling

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

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McMaster University

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 37548983 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37421995 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36641457 (View on PubMed)

Other Identifiers

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3856

Identifier Type: -

Identifier Source: org_study_id