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The Future of Viral Communications: Video-Based Health Promotion Strategies for COVID-19 Vaccinations

Primary Purpose

Health Promotion, Health Education, COVID-19 Vaccines

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Educational video
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Health Promotion

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    General public

    Healthcare professionals and public health professionals

    Arm Description

    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).

    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.

    Outcomes

    Primary Outcome Measures

    Number of participants indicating intent to vaccinate against COVID-19
    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.

    Secondary Outcome Measures

    Change in score regarding vaccine hesitation after exposure to educational materials
    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.

    Full Information

    First Posted
    May 3, 2021
    Last Updated
    May 7, 2021
    Sponsor
    McMaster University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04876885
    Brief Title
    The Future of Viral Communications: Video-Based Health Promotion Strategies for COVID-19 Vaccinations
    Official Title
    The Future of Viral Communications: Video-Based Health Promotion Strategies for COVID-19 Vaccinations
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 6, 2021 (Anticipated)
    Primary Completion Date
    June 6, 2021 (Anticipated)
    Study Completion Date
    June 6, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    McMaster University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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).
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Health Promotion, Health Education, COVID-19 Vaccines

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    This study looks at two groups. First, it directly measures response of COVID-19 vaccine hesitancy in the general public to education videos on COVID-19 vaccine development, validation, and dissemination. Second, it surveys two stakeholder groups - healthcare professionals and public health professionals to better understand their evaluation of COVID-19 vaccine education needs in the general public, based on their interpretation of commonly asked questions, best practices in health promotion, and evaluation of information already available.
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    General public
    Arm Type
    Other
    Arm Description
    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).
    Arm Title
    Healthcare professionals and public health professionals
    Arm Type
    Other
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Educational video
    Intervention Description
    Three two-minute educational videos about COVID-19 vaccine development and dissemination
    Primary Outcome Measure Information:
    Title
    Number of participants indicating intent to vaccinate against COVID-19
    Description
    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.
    Time Frame
    One month
    Secondary Outcome Measure Information:
    Title
    Change in score regarding vaccine hesitation after exposure to educational materials
    Description
    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.
    Time Frame
    One month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sarrah M Lal, MBA
    Phone
    289.808.8597
    Email
    lals2@mcmaster.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Faith L Maelzer, BHSc
    Phone
    416.576.1714
    Email
    maelzerf@mcmaster.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sarrah M Lal, MBA
    Organizational Affiliation
    McMaster University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32838242
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    32318915
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    32619436
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    33760836
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    33242386
    Citation
    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.
    Results Reference
    background
    Links:
    URL
    https://www.concordia.ca/news/stories/2020/09/15/global-covid-19-study-finds-a-strong-link-between-health-messaging-and-behaviour.html
    Description
    Importance of targeted messaging in getting people to adhere to COVID-19 safety measures

    Learn more about this trial

    The Future of Viral Communications: Video-Based Health Promotion Strategies for COVID-19 Vaccinations

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