NCT04813770

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,113

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 24, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

April 6, 2021

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2021

Completed
Last Updated

May 10, 2021

Status Verified

May 1, 2021

Enrollment Period

20 days

First QC Date

March 23, 2021

Last Update Submit

May 5, 2021

Conditions

Keywords

vaccine hesitancyvaccination uptakemessagingillness beliefstreatment beliefs

Outcome Measures

Primary Outcomes (1)

  • 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.

    Immediately post-intervention

Secondary Outcomes (3)

  • Mean COVID-19 illness coherence score as assessed by the IPQ-R

    Immediately post-intervention

  • Mean perceived necessity score as assessed by the BMQ

    Immediately post-intervention

  • Mean perceived concerns score as assessed by the BMQ

    Immediately post-intervention

Study Arms (2)

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.

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.

Behavioral: General messages

Interventions

COVID-19 vaccination information structured to address vaccination necessity and concerns.

Theory-based messages

General messages about the COVID-19 virus and the vaccination programme.

General messages

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Received at least one COVID-19 vaccination dose

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Glasgow

Glasgow, United Kingdom

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

COVID-19Vaccination Hesitancy

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesVaccination RefusalTreatment RefusalTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Katie Robb

    University of Glasgow

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
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.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Reader

Study Record Dates

First Submitted

March 23, 2021

First Posted

March 24, 2021

Study Start

April 6, 2021

Primary Completion

April 26, 2021

Study Completion

April 26, 2021

Last Updated

May 10, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will share

Anonymised individual level study data will be shared via the University of Glasgow's repository Enlighten: Research Data.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
On publication of the study results for a period of ten years.
Access Criteria
Data will be made publicly available.

Locations