- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04876885
The Future of Viral Communications: Video-Based Health Promotion Strategies for COVID-19 Vaccinations
May 7, 2021 updated by: Sarrah Lal, McMaster University
The investigators aim to study whether education, in the form of three two-minute educational videos about COVID-19 vaccine development and dissemination, reduces vaccine hesitancy and increases intent to vaccinate.
The investigators intend to use insights from this research study to develop a framework for video-based 'education prescriptions' that reduce vaccine hesitancy and increase intent to vaccinate across a number of infectious diseases.
This may have wide-ranging impact: inform practice for health promotions and public health, as well as support infectious disease related work done by healthcare professionals (e.g.
those working in travel medicine, where vaccination rates are also low).
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
The World Health Organization listed vaccine hesitancy as one of the leading threats to global health in 2019.
Vaccine hesitancy is defined as the "reluctance or refusal to vaccinate despite the availability of vaccines".
Given the novelty of the COVID-19 pandemic, hesitancy towards use of COVID-19 vaccine may be linked to the process of vaccine development and clinical trial validation of safety and/or efficacy, rather than hesitations regarding vaccines in general.
This has already inspired several education campaigns.
It is unclear whether education leads to reduced hesitance and whether reduced hesitance leads to increased intent to vaccinate.
Further, early surveys demonstrating high COVID-19 vaccine acceptance and intent to vaccinate may not reflect actual uptake, as shown by comparisons to flu vaccination uptake at a time when flu vaccines are both available, validated and largely freely accessible.
Inspiring vaccine confidence is a multifaceted challenge, and the COVID-19 pandemic has shed light on one of its aspects, specifically the public health approach to health information dissemination.
The lack of evidence-based knowledge and preparedness coupled with pandemic fatigue impacts the uptake of recommended health behaviours and puts human lives at risk.
Different people adopt different responses to health promotion materials based on a variety of socioeconomic factors.
For example, in an American study on vaccination in children, it was found that children who had never received a vaccine tended to come from affluent, college educated families, while those who had only received some recommended vaccinations came from minority families that were single parent, low-income and less likely to have completed higher education.
Almost 50% of the parents of the unvaccinated children cited concerns about vaccine safety.
The strength of beliefs leading to hesitancy may change the ability to affect intent to vaccinate.
These beliefs may be contributed to by cultural dimensions in Canada and cultures of recently immigrated individuals, with regards to individualism, collectivism, perceptions of social benefits, etc.
These factors might also impact the choice to vaccinate.
The existence of many outlets for highly varied information underscores the need for unbiased and credible education on COVID-19 vaccinations.
The investigators aim to study whether education, in the form of three two-minute educational videos about COVID-19 vaccine development and dissemination, reduces vaccine hesitancy and increases intent to vaccinate.
The investigators intend to use insights from this research study to develop a framework for video-based 'education prescriptions' that reduce vaccine hesitancy and increase intent to vaccinate across a number of infectious diseases.
This may have wide-ranging impact: inform practice for health promotions and public health, as well as support infectious disease related work done by healthcare professionals (e.g.
those working in travel medicine, where vaccination rates are also low).
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sarrah M Lal, MBA
- Phone Number: 289.808.8597
- Email: lals2@mcmaster.ca
Study Contact Backup
- Name: Faith L Maelzer, BHSc
- Phone Number: 416.576.1714
- Email: maelzerf@mcmaster.ca
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
For the general public arm:
- An understanding of the English language at a grade 8 written level
- Reside in Ontario
For the healthcare professionals and public health professionals arm:
- Licensed to practice as a healthcare professional in Ontario
- An understanding of the English language at a grade 8 written level
- Reside in Ontario
Exclusion Criteria:
- Any individuals under age 16
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: General public
The individuals recruited to the study will include those who are age 16 and older.
Due to recruitment feasibility we will focus efforts on individuals living in Ontario.
We intend to recruit individuals from COVID-19 assessment centres that are partnering in our study as well as through social media posts (Facebook, Twitter, LinkedIn).
|
Three two-minute educational videos about COVID-19 vaccine development and dissemination
|
|
Other: Healthcare professionals and public health professionals
The individuals recruited to the study will include healthcare professionals and public health professionals impacted by infectious disease outbreaks.
Social media will be used to disseminate surveys to physicians, nurses, nurse practitioners, pharmacists, and healthcare workers.
Public health units will disseminate surveys to their workforce.
|
Three two-minute educational videos about COVID-19 vaccine development and dissemination
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants indicating intent to vaccinate against COVID-19
Time Frame: One month
|
The primary end point of the study is "intent to vaccinate against COVID-19" within the general public survey.
We are looking for an increase in intent to vaccinate after the educational videos are completed.
This is a yes/no answer choice.
A change in response may be indicative of the impact of education on vaccination intent.
|
One month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in score regarding vaccine hesitation after exposure to educational materials
Time Frame: One month
|
The study seeks to understand whether providing video-based educational materials yields a positive change in score regarding vaccine hesitation (at least one point decrease) after exposure to educational materials.
A change in score may indicate that educational materials support a decrease in COVID-19 vaccination hesitancy in the population.
The scale title will be "Level of concern about the COVID-19 vaccine".
Values will range from 1-5, where 1 indicates no concern and 5 indicates high concern.
|
One month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sarrah M Lal, MBA, McMaster University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Malik AA, McFadden SM, Elharake J, Omer SB. Determinants of COVID-19 vaccine acceptance in the US. EClinicalMedicine. 2020 Sep;26:100495. doi: 10.1016/j.eclinm.2020.100495. Epub 2020 Aug 12.
- Harrison EA, Wu JW. Vaccine confidence in the time of COVID-19. Eur J Epidemiol. 2020 Apr;35(4):325-330. doi: 10.1007/s10654-020-00634-3. Epub 2020 Apr 22.
- Dodd RH, Cvejic E, Bonner C, Pickles K, McCaffery KJ; Sydney Health Literacy Lab COVID-19 group. Willingness to vaccinate against COVID-19 in Australia. Lancet Infect Dis. 2021 Mar;21(3):318-319. doi: 10.1016/S1473-3099(20)30559-4. Epub 2020 Jun 30. No abstract available.
- Edwards B, Biddle N, Gray M, Sollis K. COVID-19 vaccine hesitancy and resistance: Correlates in a nationally representative longitudinal survey of the Australian population. PLoS One. 2021 Mar 24;16(3):e0248892. doi: 10.1371/journal.pone.0248892. eCollection 2021.
- Sherman SM, Smith LE, Sim J, Amlot R, Cutts M, Dasch H, Rubin GJ, Sevdalis N. COVID-19 vaccination intention in the UK: results from the COVID-19 vaccination acceptability study (CoVAccS), a nationally representative cross-sectional survey. Hum Vaccin Immunother. 2021 Jun 3;17(6):1612-1621. doi: 10.1080/21645515.2020.1846397. Epub 2020 Nov 26.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
May 6, 2021
Primary Completion (Anticipated)
June 6, 2021
Study Completion (Anticipated)
June 6, 2021
Study Registration Dates
First Submitted
May 3, 2021
First Submitted That Met QC Criteria
May 3, 2021
First Posted (Actual)
May 7, 2021
Study Record Updates
Last Update Posted (Actual)
May 11, 2021
Last Update Submitted That Met QC Criteria
May 7, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12902
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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