Vaccine-Preventable DiseasesNCT04787913
An Evaluation of a Dynamic Web-Based Visualization of Community Immunity
A study testing herdimm, guardianmeasles and theotheredmundmeasles in people with Vaccine-Preventable Diseases, run by Laval University at 1 site in Canada.
Trial summary
This study is a PhD project conducted by Ms. Hina Hakim, supervised by Dr. Holly O. Witteman, PhD, and co-supervised Dr. Daniel Reinharz, professors and researchers at the Faculty of Medicine at Laval University. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vaccine-Preventable Diseases
- What is being tested?
- herdimm, guardianmeasles and theotheredmundmeasles
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,516 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2021to 1 Jul 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Members of the general population in Canada
- At least 18 years old
- Able to provide free and informed consent
- Able to read and understand French or English
- Able to use a computer
Who cannot join
- No internet access
Trial locations and contacts
1 site in 1 country.
About this study
This study is a PhD project conducted by Ms. Hina Hakim, supervised by Dr. Holly O. Witteman, PhD, and co-supervised Dr. Daniel Reinharz, professors and researchers at the Faculty of Medicine at Laval University. The purpose of this study is to evaluate the effects of visualization conveying the concept of community immunity or herd immunity on risk perception (towards individual, family, community and vulnerable people in communities) (primary outcome) and on emotions, attitudes, knowledge, and behavioural intentions (secondary outcomes).
Read the detailed description
Visualization is a powerful communication mechanism that uses pre-attentive processing to communicate large amounts of information rapidly in understandable and compelling ways (Healey and Enns 2012). A systematic review demonstrates that there are some interventions available for conveying the concept of community immunity, and very few evaluate interventions for their effects on vaccine intentions and uptake as well as their precursors, such as knowledge, attitudes, knowledge and none on emotions (Hakim et al. 2018).
The purpose of this study is to evaluate the effects of visualization conveying the concept of community immunity on risk perception (to individual, family, community and vulnerable people in communities) (primary outcome) and on emotions, attitudes, knowledge, and behavioural intentions (secondary outcomes).
- Conditions
- Vaccine-Preventable Diseases
- Being tested
- herdimm, guardianmeasles, theotheredmundmeasles, sbsnewsgeneric, publichealthagencycanadaflu
- Keywords
- herd immunity, community immunity, web-based application, visualization
- Medical subject headings
- Vaccine-Preventable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
herdimmBehavioural
In this visualization participants can build their own avatar representing themselves and 8 other avatars representing people around them, like their family or coworkers. Our visualization then uses these avatars in a brief narrated video explaining how herd immunity works.
guardianmeaslesBehavioural
A screen capture of an interactive visualization: https://www.theguardian.com/society/ng-interactive/2015/feb/05/-sp-watch-how-measles-outbreak-spreads-when-kids-get-vaccinated
theotheredmundmeaslesBehavioural
A gif showing measles spreading through populations with differing levels of vaccine coverage: https://imgur.com/gallery/8M7q8#J7LANQ4
sbsnewsgenericBehavioural
A video showing how herd immunity works in general: https://www.sbs.com.au/news/two-sydney-babies-too-young-to-be-vaccinated-infected-with-measles
publichealthagencycanadafluBehavioural
A video showing how herd immunity works in the context of influenza: https://www.canada.ca/fr/sante-publique/services/video/la-grippe-n-en-passez-pas-les-maux.html
robertkochgenericBehavioural
A web-based application showing how herd immunity works in general: http://rocs.hu-berlin.de/D3/herd/
| Study group | Role | What they receive |
|---|---|---|
| controlgeneric | No intervention | No intervention provided. Participant answers outcome questions about an unnamed vaccine-preventable disease. English and French. |
| controlmeasles | No intervention | No intervention provided. Participant answers outcome questions about measles. English and French. |
| controlpertussis | No intervention | No intervention provided. Participant answers outcome questions about pertussis. English and French. |
| controlflu | No intervention | No intervention provided. Participant answers outcome questions about flu. English and French. |
| herdimmgeneric | Experimental | Web-based application (main intervention) provided. Participant answers outcome questions about an unnamed vaccine-preventable disease. English and French. Receives: Behavioral: herdimm |
| herdimmmeasles | Experimental | Web-based application (main intervention) provided. Participant answers outcome questions about measles. English and French. Receives: Behavioral: herdimm |
| herdimmpertussis | Experimental | Web-based application (main intervention) provided. Participant answers outcome questions about pertussis. English and French. Receives: Behavioral: herdimm |
| herdimmflu | Experimental | Web-based application (main intervention) provided. Participant answers outcome questions about flu. English and French. Receives: Behavioral: herdimm |
| robertkochgeneric | Active comparator | Web-based application (comparator) provided. Participant answers outcome questions about an unnamed vaccine-preventable disease. English only. Receives: Behavioral: robertkochgeneric |
| sbsnewsgeneric | Active comparator | Video (comparator) provided. Participant answers outcome questions about an unnamed vaccine-preventable disease. English only. Receives: Behavioral: sbsnewsgeneric |
| guardianmeasles | Active comparator | Video (comparator) provided. Participant answers outcome questions about measles. English only. Receives: Behavioral: guardianmeasles |
| theotheredmundmeasles | Active comparator | Video (comparator) provided. Participant answers outcome questions about measles. English only. Receives: Behavioral: theotheredmundmeasles |
| publichealthagencycanadaflu | Active comparator | Video (comparator) provided. Participant answers outcome questions about flu. English and French. Receives: Behavioral: publichealthagencycanadaflu |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk perception
6 items assessing risk perception (item 1 = risk perception as comprehension, scale 0-100, higher numbers better; items 2-5 = risk perception as feelings, scale 1-7, higher numbers better; complete list of items and response wording available in uploaded questionnaire herdimm_phase3_questionnaire_2021-03-01.pdf)
Measured: immediately after intervention or control
Secondary outcomes (5)
Emotions
5 items (e.g., "I am worried about getting [disease]", "I would feel guilty if a vulnerable person (a baby, a young child, an older person, a cancer patient) got [disease] from me") with a 7-point Likert-type response scale ranging from "strongly disagree" to "strongly agree"; higher numbers may be better; complete list of items and response wording available in uploaded questionnaire herdimm_phase3_questionnaire_2021-03-01.pdf
Measured: immediately after intervention or control
Knowledge
15 items, with 2 multiple choice questions and 13 true/false questions, for a total possible score ranging from 0 to 18; higher numbers better; complete list of items available in uploaded questionnaire herdimm_phase3_questionnaire_2021-03-01.pdf
Measured: immediately after intervention or control
Trust in information
Single item (Control: "During your life, you may have seen information about vaccines. Thinking about the information you have seen, how trustworthy was it?" Treatment: "Earlier, you saw a {{video, website}} about herd immunity. Thinking about the {{video, website}} you saw earlier, how trustworthy was the information in it?") with Likert-type response options 1 = not at all trustworthy, 2 = moderately untrustworthy, 3 = slightly untrustworthy, 4 = neutral, 5 = slightly trustworthy, 6 = moderately trustworthy, 7 = strongly trustworthy
Measured: immediately after intervention or control
Vaccination intentions
Questions conditioned on whether the participant indicates they believe they are already immune to the disease in question, e.g., "Imagine you were not already immune to {{measles/pertussis/influenza/a vaccine preventable disease}}. If you were eligible to receive a free vaccine against {{measles/pertussis/influenza/a vaccine-preventable disease}}, how likely would you be to get vaccinated?" Response scale on a slider: 0 = extremely unlikely, I would definitely NOT be vaccinated; 100 = extremely likely, I would definitely BE vaccinated; higher numbers better.
Measured: immediately after intervention or control
5C scale
"5C scale: 15-item validated scale measuring the psychological antecedents of vaccination (Betsch et al., 2018)"
Measured: immediately after intervention or control
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start1 Mar 2021
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine-Preventable DiseasesStudies of the same condition, open and under way.
- More trials run by Laval 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
- Factorial
- Model description
- This study will be a multi-armed factorial randomized controlled trial. Each participant will be randomly allocated to focus on one of four possible vaccine-preventable diseases: measles, pertussis, flu (influenza), or a generic vaccine-preventable disease (hereby referred to as "generic"). All aspects of the study (visualization, questionnaire) will be focused on that one disease for that participant. The primary and secondary outcomes of the study which are risk perception, emotion, knowledge, trust in information provided, attitudes and a validated scale about vaccination (Betsch et al. 2018) will be assessed in an online questionnaire. Because three online visualizations are available only in English whereas our study will be conducted in both English and French, we will use slightly different randomization patterns for English- and French-speaking participants.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 5,516 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Holly Witteman, PhD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04787913
- Sponsor's protocol ID
- herdimm
- Status last verified
- Aug 2024
- First submitted
- 4 Mar 2021
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data (answers to questions in the survey including socio-demographic information) will be deposited in a public repository (Dataverse de l'Université Laval (Laval University)) which will allow data sharing with the scientific community. No information that would allow anyone to identify a person will be deposited in this public repository. Study protocol and statistical analysis plan have been deposited in Open Science Framework.
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of a Dynamic Web-Based Visualization of Community Immunity
- ClinicalTrials.gov ID
- NCT04787913
- Acronym / sponsor ID
- herdimm
- Conditions
- Vaccine-Preventable Diseases
- Keywords
- herd immunity, community immunity, web-based application, visualization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,516 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 9 Mar 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.
This study is a PhD project conducted by Ms. Hina Hakim, supervised by Dr. Holly O. Witteman, PhD, and co-supervised Dr. Daniel Reinharz, professors and researchers at the Faculty of Medicine at Laval University. The purpose of this study is to evaluate the effects of visualization conveying the concept of community immunity or herd immunity on risk perception (towards individual, family, community and vulnerable people in communities) (primary outcome) and on emotions, attitudes, knowledge, and behavioural intentions (secondary outcomes).
Detailed description
Visualization is a powerful communication mechanism that uses pre-attentive processing to communicate large amounts of information rapidly in understandable and compelling ways (Healey and Enns 2012). A systematic review demonstrates that there are some interventions available for conveying the concept of community immunity, and very few evaluate interventions for their effects on vaccine intentions and uptake as well as their precursors, such as knowledge, attitudes, knowledge and none on emotions (Hakim et al. 2018).
The purpose of this study is to evaluate the effects of visualization conveying the concept of community immunity on risk perception (to individual, family, community and vulnerable people in communities) (primary outcome) and on emotions, attitudes, knowledge, and behavioural intentions (secondary outcomes).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 13
- Model description
- This study will be a multi-armed factorial randomized controlled trial. Each participant will be randomly allocated to focus on one of four possible vaccine-preventable diseases: measles, pertussis, flu (influenza), or a generic vaccine-preventable disease (hereby referred to as "generic"). All aspects of the study (visualization, questionnaire) will be focused on that one disease for that participant. The primary and secondary outcomes of the study which are risk perception, emotion, knowledge, trust in information provided, attitudes and a validated scale about vaccination (Betsch et al. 2018) will be assessed in an online questionnaire. Because three online visualizations are available only in English whereas our study will be conducted in both English and French, we will use slightly different randomization patterns for English- and French-speaking participants.
| Arm | Type | Receives |
|---|---|---|
| controlgeneric | No intervention | –No intervention provided. Participant answers outcome questions about an unnamed vaccine-preventable disease. English and French. |
| controlmeasles | No intervention | –No intervention provided. Participant answers outcome questions about measles. English and French. |
| controlpertussis | No intervention | –No intervention provided. Participant answers outcome questions about pertussis. English and French. |
| controlflu | No intervention | –No intervention provided. Participant answers outcome questions about flu. English and French. |
| herdimmgeneric | Experimental | Behavioral: herdimmWeb-based application (main intervention) provided. Participant answers outcome questions about an unnamed vaccine-preventable disease. English and French. |
| herdimmmeasles | Experimental | Behavioral: herdimmWeb-based application (main intervention) provided. Participant answers outcome questions about measles. English and French. |
| herdimmpertussis | Experimental | Behavioral: herdimmWeb-based application (main intervention) provided. Participant answers outcome questions about pertussis. English and French. |
| herdimmflu | Experimental | Behavioral: herdimmWeb-based application (main intervention) provided. Participant answers outcome questions about flu. English and French. |
| robertkochgeneric | Active comparator | Behavioral: robertkochgenericWeb-based application (comparator) provided. Participant answers outcome questions about an unnamed vaccine-preventable disease. English only. |
| sbsnewsgeneric | Active comparator | Behavioral: sbsnewsgenericVideo (comparator) provided. Participant answers outcome questions about an unnamed vaccine-preventable disease. English only. |
| guardianmeasles | Active comparator | Behavioral: guardianmeaslesVideo (comparator) provided. Participant answers outcome questions about measles. English only. |
| theotheredmundmeasles | Active comparator | Behavioral: theotheredmundmeaslesVideo (comparator) provided. Participant answers outcome questions about measles. English only. |
| publichealthagencycanadaflu | Active comparator | Behavioral: publichealthagencycanadafluVideo (comparator) provided. Participant answers outcome questions about flu. English and French. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Members of the general population in Canada
- At least 18 years old
- Able to provide free and informed consent
- Able to read and understand French or English
- Able to use a computer
Key exclusion criteria (1 listed)
- No internet access
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 |
|---|---|---|
| herdimmIn this visualization participants can build their own avatar representing themselves and 8 other avatars representing people around them, like their family or coworkers. Our visualization then uses these avatars in a brief narrated video explaining how herd immunity works. | Behavioural | herdimmflu, herdimmgeneric, herdimmmeasles, herdimmpertussis |
| guardianmeaslesA screen capture of an interactive visualization: https://www.theguardian.com/society/ng-interactive/2015/feb/05/-sp-watch-how-measles-outbreak-spreads-when-kids-get-vaccinated | Behavioural | guardianmeasles |
| theotheredmundmeaslesA gif showing measles spreading through populations with differing levels of vaccine coverage: https://imgur.com/gallery/8M7q8#J7LANQ4 | Behavioural | theotheredmundmeasles |
| sbsnewsgenericA video showing how herd immunity works in general: https://www.sbs.com.au/news/two-sydney-babies-too-young-to-be-vaccinated-infected-with-measles | Behavioural | sbsnewsgeneric |
| publichealthagencycanadafluA video showing how herd immunity works in the context of influenza: https://www.canada.ca/fr/sante-publique/services/video/la-grippe-n-en-passez-pas-les-maux.html | Behavioural | publichealthagencycanadaflu |
| robertkochgenericA web-based application showing how herd immunity works in general: http://rocs.hu-berlin.de/D3/herd/ | Behavioural | robertkochgeneric |
Primary outcome
Risk perception
Time frame: immediately after intervention or control
6 items assessing risk perception (item 1 = risk perception as comprehension, scale 0-100, higher numbers better; items 2-5 = risk perception as feelings, scale 1-7, higher numbers better; complete list of items and response wording available in uploaded questionnaire herdimm_phase3_questionnaire_2021-03-01.pdf)
5 secondary outcomes
Emotions
Time frame: immediately after intervention or control
Knowledge
Time frame: immediately after intervention or control
Trust in information
Time frame: immediately after intervention or control
Vaccination intentions
Time frame: immediately after intervention or control
5C scale
Time frame: immediately after intervention or control
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 29 Aug 2024.
- Individual participant dataSharing planned: Yes. Anonymized data (answers to questions in the survey including socio-demographic information) will be deposited in a public repository (Dataverse de l'Université Laval (Laval University)) which will allow data sharing with the scientific community. No information that would allow anyone to identify a person will be deposited in this public repository. Study protocol and statistical analysis plan have been deposited in Open Science Framework.
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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.
Holly Witteman, PhD principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing herdimm, guardianmeasles and theotheredmundmeasles in people with Vaccine-Preventable Diseases, run by Laval 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 5 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 29 Aug 2024. 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?
Risk perception (time frame: immediately after intervention or control). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Aug 2024.