VaccinationNCT04813770
The Impact of Theory-based Messaging on Covid-19 Vaccination Intentions
A study testing Theory-based messages and General messages in people with Vaccination and Covid19, run by University of Glasgow at 1 site in United Kingdom.
Trial summary
Uptake of vaccination against COVID-19 is key to controlling the pandemic. However, a significant proportion of people report that they do not intend to have a vaccine, often because of concerns they have about its side effects or safety. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vaccination, Covid19
- What is being tested?
- Theory-based messages and General messages
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,113 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Apr 2021to 26 Apr 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
- Willing and able to give informed consent for participation in the trial
- Aged 18 years or above
- Resident in Scotland
Who cannot join
- Received at least one COVID-19 vaccination dose
Trial locations and contacts
1 site in 1 country.
About this study
Uptake of vaccination against COVID-19 is key to controlling the pandemic. However, a significant proportion of people report that they do not intend to have a vaccine, often because of concerns they have about its side effects or safety. It is important to identify ways to communicate information about the vaccines that facilitate informed decisions rather than promoting uptake through coercion. This study will assess whether theory-based messages can change beliefs and increase intentions to receive a COVID-19 vaccine in Scotland. The messages will be based on publicly available information about the need for COVID-19 vaccination and the safety of the vaccines, and structured to address specific types of treatment beliefs. Participants will be randomised to either a group shown the messages or a control group shown general information messages about the COVID-19 virus and vaccination programme. By comparing the two groups we aim to test what impact the theory-based messages have on intentions and beliefs about COVID-19 vaccination.
- Conditions
- Vaccination, Covid19
- Being tested
- Theory-based messages, General messages
- Keywords
- vaccine hesitancy, vaccination uptake, messaging, illness beliefs, treatment beliefs
- Medical subject headings
- COVID-19, Vaccination Hesitancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theory-based messagesBehavioural
COVID-19 vaccination information structured to address vaccination necessity and concerns.
General messagesBehavioural
General messages about the COVID-19 virus and the vaccination programme.
| Study group | Role | What they receive |
|---|---|---|
| Theory-based messages | Experimental | Theory-based health messages about COVID-19 and COVID-19 vaccination, the necessity of COVID-19 vaccination to oneself and others, and COVID-19 vaccine regulatory approval processes. These messages are based on publicly available information and are hypothesised to increase perceived necessity and reduce concerns about vaccination, and target known barriers to vaccine uptake. Receives: Behavioral: Theory-based messages |
| General messages | Active comparator | General messages about the COVID-19 virus and the vaccination programme. These messages do not target necessity and concerns, but are anticipated to promote understanding of the pandemic. Receives: Behavioral: General messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Covid-19 vaccination intention measured by a single item and aggregated as the proportion of intenders.
Participants will be asked: "If you were invited to have a COVID-19 vaccination would you take the vaccine?" Those responding "yes, probably" or "yes, definitely" will be treated as intenders. Those responding "don't know", "probably not" or "definitely not" will be treated as non-intenders.
Measured: Immediately post-intervention
Secondary outcomes (3)
Mean COVID-19 illness coherence score as assessed by the IPQ-R
Self-reported COVID-19 illness coherence as assessed by the the illness coherence subscale of the revised Illness Perception Questionnaire (IPQ-R), with a minimum score of 5, a maximum score of 25 and a higher score representing greater personal understanding of COVID-19.
Measured: Immediately post-intervention
Mean perceived necessity score as assessed by the BMQ
Self-reported perceived necessity of a COVID-19 vaccine as assessed by the Specific-Necessity subscale of the Beliefs about Medicines Questionnaire (BMQ), with a minimum score of 5, a maximum score of 25 and a higher score representing greater perceived necessity of a COVID-19 vaccine.
Measured: Immediately post-intervention
Mean perceived concerns score as assessed by the BMQ
Self-reported perceived concerns about a COVID-19 vaccine as assessed by the Specific-Concerns subscale of the Beliefs about Medicines Questionnaire (BMQ), with a minimum score of 5, a maximum score of 25 and a higher score representing greater perceived concerns about a COVID-19 vaccine.
Measured: Immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start6 Apr 2021
- Primary completion26 Apr 2021
- Study completion26 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for VaccinationStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,113 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katie Robb, University of Glasgow
- Investigators
- Katie Robb, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04813770
- Sponsor's protocol ID
- 200200052
- Status last verified
- May 2021
- First submitted
- 23 Mar 2021
- Last updated
- 10 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised individual level study data will be shared via the University of Glasgow's repository Enlighten: Research Data.
Publications
Young B, Kotzur M, Gatting L, Bonner C, Ayre J, McConnachie A, Batcup C, McCaffery K, O'Carroll R, Robb KA. The impact of theory-based messages on COVID-19 vaccination intentions: a structured summary of a study protocol for a randomised controlled trial. Trials. 2021 Apr 29;22(1):311. doi: 10.1186/s13063-021-05277-7.
PubMed 33926540
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Theory-based Messaging on Covid-19 Vaccination Intentions
- ClinicalTrials.gov ID
- NCT04813770
- Acronym / sponsor ID
- 200200052
- Conditions
- Vaccination, Covid19
- Keywords
- vaccine hesitancy, vaccination uptake, messaging, illness beliefs, treatment beliefs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,113 participants (actual)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Study start
- 6 Apr 2021 (actual)
- Primary completion
- 26 Apr 2021 (actual)
- Study completion
- 26 Apr 2021 (actual)
- First posted
- 24 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.
Uptake of vaccination against COVID-19 is key to controlling the pandemic. However, a significant proportion of people report that they do not intend to have a vaccine, often because of concerns they have about its side effects or safety. It is important to identify ways to communicate information about the vaccines that facilitate informed decisions rather than promoting uptake through coercion. This study will assess whether theory-based messages can change beliefs and increase intentions to receive a COVID-19 vaccine in Scotland. The messages will be based on publicly available information about the need for COVID-19 vaccination and the safety of the vaccines, and structured to address specific types of treatment beliefs. Participants will be randomised to either a group shown the messages or a control group shown general information messages about the COVID-19 virus and vaccination programme. By comparing the two groups we aim to test what impact the theory-based messages have on intentions and beliefs about COVID-19 vaccination.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Theory-based messages | Experimental | Behavioral: Theory-based messagesTheory-based health messages about COVID-19 and COVID-19 vaccination, the necessity of COVID-19 vaccination to oneself and others, and COVID-19 vaccine regulatory approval processes. These messages are based on publicly available information and are hypothesised to increase perceived necessity and reduce concerns about vaccination, and target known barriers to vaccine uptake. |
| General messages | Active comparator | Behavioral: General messagesGeneral messages about the COVID-19 virus and the vaccination programme. These messages do not target necessity and concerns, but are anticipated to promote understanding of the pandemic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Willing and able to give informed consent for participation in the trial
- Aged 18 years or above
- Resident in Scotland
Key exclusion criteria (1 listed)
- Received at least one COVID-19 vaccination dose
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 |
|---|---|---|
| Theory-based messagesCOVID-19 vaccination information structured to address vaccination necessity and concerns. | Behavioural | Theory-based messages |
| General messagesGeneral messages about the COVID-19 virus and the vaccination programme. | Behavioural | General messages |
Primary outcome
Covid-19 vaccination intention measured by a single item and aggregated as the proportion of intenders.
Time frame: Immediately post-intervention
Participants will be asked: "If you were invited to have a COVID-19 vaccination would you take the vaccine?" Those responding "yes, probably" or "yes, definitely" will be treated as intenders. Those responding "don't know", "probably not" or "definitely not" will be treated as non-intenders.
3 secondary outcomes
Mean COVID-19 illness coherence score as assessed by the IPQ-R
Time frame: Immediately post-intervention
Mean perceived necessity score as assessed by the BMQ
Time frame: Immediately post-intervention
Mean perceived concerns score as assessed by the BMQ
Time frame: Immediately post-intervention
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 10 May 2021.
- Derived from this study: PubMed 33926540Young B, Kotzur M, Gatting L, Bonner C, Ayre J, McConnachie A, Batcup C, McCaffery K, O'Carroll R, Robb KA. The impact of theory-based messages on COVID-19 vaccination intentions: a structured summary of a study protocol for a randomised controlled trial. Trials. 2021 Apr 29;22(1):311. doi: 10.1186/s13063-021-05277-7.
- Individual participant dataSharing planned: Yes. Anonymised individual level study data will be shared via the University of Glasgow's repository Enlighten: Research Data.
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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.
Katie Robb principal investigator
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Theory-based messages and General messages in people with Vaccination and Covid19, run by University of Glasgow at 1 site in United Kingdom.
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 3 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 10 May 2021. 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 United Kingdom. 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?
Covid-19 vaccination intention measured by a single item and aggregated as the proportion of intenders. (time frame: Immediately post-intervention). 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 NCT04813770, which also lists 1 linked publication.
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 10 May 2021.