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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
Other: Educational video
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.
Other: Educational video
Three two-minute educational videos about COVID-19 vaccine development and dissemination

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
McMaster University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 6, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 6, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 6, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 3, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 7, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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