Health PromotionNCT04876885
The Future of Viral Communications: Video-Based Health Promotion Strategies for COVID-19 Vaccinations
A study testing Educational video in people with Health Promotion and Health Education, run by McMaster University.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Promotion, Health Education, COVID-19 Vaccines
- What is being tested?
- Educational video
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 6 May 2021to 6 Jun 2021
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Any individuals under age 16
Trial locations and contacts
No sites are listed yet.
About this study
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).
Read the 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).
- Conditions
- Health Promotion, Health Education, COVID-19 Vaccines
- Being tested
- Educational video
- Medical subject headings
- Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational videoOther
Three two-minute educational videos about COVID-19 vaccine development and dissemination
| Study group | Role | What they receive |
|---|---|---|
| General public | Other | 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). Receives: Other: Educational video |
| Healthcare professionals and public health professionals | Other | 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. Receives: Other: Educational video |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One month
Secondary outcomes (1)
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.
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start6 May 2021 (estimated)
- Primary completion6 Jun 2021 (estimated)
- Study completion6 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Health PromotionStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarrah Lal, McMaster University
- Investigators
- Sarrah M Lal, MBA, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04876885
- Sponsor's protocol ID
- 12902
- Status last verified
- May 2021
- First submitted
- 3 May 2021
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32838242Harrison 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.
PubMed 32318915Dodd 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.
PubMed 32619436Edwards 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.
PubMed 33760836Sherman 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.
PubMed 33242386
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Future of Viral Communications: Video-Based Health Promotion Strategies for COVID-19 Vaccinations
- ClinicalTrials.gov ID
- NCT04876885
- Acronym / sponsor ID
- 12902
- Conditions
- Health Promotion, Health Education, COVID-19 Vaccines
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 6 May 2021 (estimated)
- Primary completion
- 6 Jun 2021 (estimated)
- Study completion
- 6 Jun 2021 (estimated)
- First posted
- 7 May 2021 (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.
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).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| General public | Other | Other: Educational videoThe 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). |
| Healthcare professionals and public health professionals | Other | Other: Educational videoThe 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- An understanding of the English language at a grade 8 written level
- Reside in Ontario
- Licensed to practice as a healthcare professional in Ontario
- An understanding of the English language at a grade 8 written level
- Reside in Ontario
Key exclusion criteria (1 listed)
- Any individuals under age 16
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 |
|---|---|---|
| Educational videoThree two-minute educational videos about COVID-19 vaccine development and dissemination | Other | General public, Healthcare professionals and public health professionals |
Primary outcome
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.
1 secondary outcome
Change in score regarding vaccine hesitation after exposure to educational materials
Time frame: One month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
- Background: PubMed 32838242Malik 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.
- Background: PubMed 32318915Harrison 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.
- Background: PubMed 32619436Dodd 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.
- Background: PubMed 33760836Edwards 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.
- Background: PubMed 33242386Sherman 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.
- Importance of targeted messaging in getting people to adhere to COVID-19 safety measuresLink provided by the sponsor.
- 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.
Sarrah M Lal, MBA principal investigator
McMaster University
Questions about this trial
What is this clinical trial studying?
A study testing Educational video in people with Health Promotion and Health Education, run by McMaster University.
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 7 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: status not confirmed, as of the sponsor's last update on 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarrah M Lal, MBA (289.808.8597, lals2@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants indicating intent to vaccinate against COVID-19 (time frame: One month). 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 NCT04876885, which also lists 5 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 11 May 2021.