COVID-19eCOVID-PLRNCT05358990
Knowledge Mobilization Activities to Support Decision-Making by Youth, Parents and Adults: Study Protocol
A study testing Plain Language Recommendation (PLR) and Standard Language Version (SLV) in people with COVID-19, run by McMaster University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Plain Language Recommendation (PLR) and Standard Language Version (SLV)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 997 participants
- Where
- 1 siteCanada
- Study dates
- 25 May 2022to 25 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Individuals not fitting any of the above age categories or language requirement
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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).
- Conditions
- COVID-19
- Being tested
- Plain Language Recommendation (PLR), Standard Language Version (SLV)
- Keywords
- electronic Coronavirus Disease Recommendation Map (eCOVID RecMap), Plain Language Recommendation, Standard Language Versions, Public Engagement, Knowledge Mobilization
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plain Language Recommendation (PLR)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)Other
Original recommendation as initially published by the guideline organization.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Plain Language Recommendation (PLR) |
| Standard Language Version (SLV) | Active comparator | Original recommendation as initially published by the guideline organization. Receives: Other: Standard Language Version (SLV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Duration of survey (approximately 25 minutes) at baseline
Secondary outcomes (4)
Accessibility and Usability on a Seven-Point Likert Scale
Accessibility and Usability is defined as the ability to find/access, and use the presented information. This outcome considers the three following domains: (1) how easy it was to find information, (2) how easy it was to understand the information (perception), and (3) whether the information was presented in a way that could be helpful for making an informed health decision. Participants will have to indicate the degree of agreement with six statements, measured using the original 7-point Likert scale (1 being strongly disagree, 4 being neutral, and 7 being strongly agree). The outcome 'overall accessibility of information' will be measured using the 7-point Likert-type scale.
Measured: Duration of survey (approximately 25 minutes) at baseline
Satisfaction on a Seven-Point Likert Scale
Satisfaction is defined as participants' impression of the recommendation's presentation. This will be measured using questions related to participants' level of satisfaction with the different features of the format (e.g. feature of explaining the certainty of the evidence). Participants will have to indicate the degree of satisfaction with three questions measured using the original 7-point Likert-type scale (11 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neutral, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied). Participants will also have to answer three open-ended questions to get their input on what they liked and disliked in the format.
Measured: Duration of survey (approximately 25 minutes) at baseline
Intended Behavior on a Seven-Point Likert Scale and Multiple Choice Questions
Intended behavior is defined as participants' intention in adopting and following the shared recommendation. Participants will answer a question on whether they have already followed and implemented the recommendation in their jurisdiction and have them respond with yes, no, unsure, or not applicable. Subsequently, they will be asked how likely it is that they will follow and share the recommendation through two questions measured using a 7-point Likert-scale (1 = very unlikely, 2 = unlikely, 3 = somewhat unlikely, 4 = neutral, 5 = somewhat likely, 6 = likely, 7 = very likely.
Measured: Duration of survey (approximately 25 minutes) at baseline
Preference on a Seven-Point Likert-Scale
Preference is defined as a greater liking of one format over the other (PLR or SLV). All participants will get to compare the optimized PLR and the SLV; after having completed the tasks in the group they were randomized to, participants will review the alternative format and indicate their preference for one of the two formats using a 7-point Likert-type scale (1 = strongly prefer SLV, 2 = prefer SLV, 3 = somewhat prefer SLV, 4 = same preference for SLV and PLR, 5 = somewhat prefer PLR, 6 = prefer PLR, 7 = strongly prefer PLR).
Measured: Duration of survey (approximately 25 minutes) at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start25 May 2022
- Primary completion25 Oct 2022
- Study completion25 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 997 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Western University, The Hospital for Sick Children, University of Alberta
- Responsible party
- Principal investigator, Holger Schunemann, McMaster University
- Investigators
- Holger J Schunemann, MD, PHD, Study chair, McMaster UniversityKevin Pottie, Principal investigator, Western UniversityMartin Offringa, Principal investigator, The Hospital for Sick Children Research InstituteNancy Butcher, Principal investigator, The Hospital for Sick Children Research InstituteLisa Hartling, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05358990
- Sponsor's protocol ID
- 3856
- Acronym
- eCOVID-PLR
- Status last verified
- Dec 2022
- First submitted
- 28 Apr 2022
- Last updated
- 14 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37548983Elliott 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.
PubMed 37421995Charide 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.
PubMed 36641457
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05358990
- Acronym / sponsor ID
- eCOVID-PLR / 3856
- Conditions
- COVID-19
- Keywords
- electronic Coronavirus Disease Recommendation Map (eCOVID RecMap), Plain Language Recommendation, Standard Language Versions, Public Engagement, Knowledge Mobilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 997 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Western University, The Hospital for Sick Children, University of Alberta
- Study start
- 25 May 2022 (actual)
- Primary completion
- 25 Oct 2022 (actual)
- Study completion
- 25 Oct 2022 (actual)
- First posted
- 3 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plain Language Recommendation (PLR) | Experimental | Other: Plain Language Recommendation (PLR)New easy to read COVID-19 recommendations available on the COVID19 Living Map of Recommendations and Gateway to Contextualization (RecMap). |
| Standard Language Version (SLV) | Active comparator | Other: Standard Language Version (SLV)Original recommendation as initially published by the guideline organization. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Individuals not fitting any of the above age categories or language requirement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plain Language Recommendation (PLR)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)Original recommendation as initially published by the guideline organization. | Other | Standard Language Version (SLV) |
Primary outcome
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).
4 secondary outcomes
Accessibility and Usability on a Seven-Point Likert Scale
Time frame: Duration of survey (approximately 25 minutes) at baseline
Satisfaction on a Seven-Point Likert Scale
Time frame: Duration of survey (approximately 25 minutes) at baseline
Intended Behavior on a Seven-Point Likert Scale and Multiple Choice Questions
Time frame: Duration of survey (approximately 25 minutes) at baseline
Preference on a Seven-Point Likert-Scale
Time frame: Duration of survey (approximately 25 minutes) at baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
- Derived from this study: PubMed 37548983Stallwood 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.
- Derived from this study: PubMed 37421995Elliott 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.
- Derived from this study: PubMed 36641457Charide 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Holger J Schunemann, MD, PHD study chair
McMaster University
Kevin Pottie principal investigator
Western University
Martin Offringa principal investigator
The Hospital for Sick Children Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plain Language Recommendation (PLR) and Standard Language Version (SLV) in people with COVID-19, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Understanding with Multiple Choice Questions (time frame: Duration of survey (approximately 25 minutes) at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05358990, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2022.