search
Back to results

The Impact of Theory-based Messaging on Covid-19 Vaccination Intentions

Primary Purpose

Vaccination, Covid19

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Theory-based messages
General messages
Sponsored by
University of Glasgow
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Vaccination focused on measuring vaccine hesitancy, vaccination uptake, messaging, illness beliefs, treatment beliefs

Eligibility Criteria

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

Inclusion Criteria:

  • Willing and able to give informed consent for participation in the trial
  • Aged 18 years or above
  • Resident in Scotland

Exclusion Criteria:

  • Received at least one COVID-19 vaccination dose

Sites / Locations

  • University of Glasgow

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Theory-based messages

General messages

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
March 23, 2021
Last Updated
May 5, 2021
Sponsor
University of Glasgow
search

1. Study Identification

Unique Protocol Identification Number
NCT04813770
Brief Title
The Impact of Theory-based Messaging on Covid-19 Vaccination Intentions
Official Title
The Impact of Theory-based Messaging on Covid-19 Vaccination Intentions
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
April 6, 2021 (Actual)
Primary Completion Date
April 26, 2021 (Actual)
Study Completion Date
April 26, 2021 (Actual)

3. Sponsor/Collaborators

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

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaccination, Covid19
Keywords
vaccine hesitancy, vaccination uptake, messaging, illness beliefs, treatment beliefs

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
Participants will not be blinded to the assigned intervention but will not be informed of the purpose of the study until they have completed the follow-up survey, at which point they will be debriefed. Investigators will be blinded to allocation because all procedures will be undertaken digitally and remotely without any investigator contact with participants.
Allocation
Randomized
Enrollment
1113 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Theory-based messages
Arm Type
Experimental
Arm Description
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.
Arm Title
General messages
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Theory-based messages
Intervention Description
COVID-19 vaccination information structured to address vaccination necessity and concerns.
Intervention Type
Behavioral
Intervention Name(s)
General messages
Intervention Description
General messages about the COVID-19 virus and the vaccination programme.
Primary Outcome Measure Information:
Title
Covid-19 vaccination intention measured by a single item and aggregated as the proportion of intenders.
Description
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.
Time Frame
Immediately post-intervention
Secondary Outcome Measure Information:
Title
Mean COVID-19 illness coherence score as assessed by the IPQ-R
Description
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.
Time Frame
Immediately post-intervention
Title
Mean perceived necessity score as assessed by the BMQ
Description
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.
Time Frame
Immediately post-intervention
Title
Mean perceived concerns score as assessed by the BMQ
Description
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.
Time Frame
Immediately post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Willing and able to give informed consent for participation in the trial Aged 18 years or above Resident in Scotland Exclusion Criteria: Received at least one COVID-19 vaccination dose
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katie Robb
Organizational Affiliation
University of Glasgow
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Glasgow
City
Glasgow
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymised individual level study data will be shared via the University of Glasgow's repository Enlighten: Research Data.
IPD Sharing Time Frame
On publication of the study results for a period of ten years.
IPD Sharing Access Criteria
Data will be made publicly available.
Citations:
PubMed Identifier
33926540
Citation
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.
Results Reference
derived

Learn more about this trial

The Impact of Theory-based Messaging on Covid-19 Vaccination Intentions

We'll reach out to this number within 24 hrs