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

May 5, 2021 updated by: Katie Robb, University of Glasgow
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1113

Phase

  • 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 Locations

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Theory-based messages
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.
Behavioral: Theory-based messages
COVID-19 vaccination information structured to address vaccination necessity and concerns.
Active Comparator: General messages
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.
Behavioral: General messages
General messages about the COVID-19 virus and the vaccination programme.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean COVID-19 illness coherence score as assessed by the IPQ-R
Time Frame: Immediately post-intervention
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.
Immediately post-intervention
Mean perceived necessity score as assessed by the BMQ
Time Frame: Immediately post-intervention
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.
Immediately post-intervention
Mean perceived concerns score as assessed by the BMQ
Time Frame: Immediately post-intervention
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.
Immediately post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Glasgow

Investigators

  • Principal Investigator: Katie Robb, University of Glasgow

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

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 (Actual)

April 6, 2021

Primary Completion (Actual)

April 26, 2021

Study Completion (Actual)

April 26, 2021

Study Registration Dates

First Submitted

March 23, 2021

First Submitted That Met QC Criteria

March 23, 2021

First Posted (Actual)

March 24, 2021

Study Record Updates

Last Update Posted (Actual)

May 10, 2021

Last Update Submitted That Met QC Criteria

May 5, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200200052

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

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.

Clinical Trials on Covid19

Clinical Trials on Theory-based messages

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lebanon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe