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Influenza 2020/2021

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04546854
Recruitment Status : Completed
First Posted : September 14, 2020
Last Update Posted : September 25, 2020
Sponsor:
Information provided by (Responsible Party):
Kelly Ann Schmidtke, University of Warwick

Tracking Information
First Submitted Date  ICMJE September 5, 2020
First Posted Date  ICMJE September 14, 2020
Last Update Posted Date September 25, 2020
Actual Study Start Date  ICMJE September 21, 2020
Actual Primary Completion Date September 21, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2020)
Intentions to take up the seasonal influenza vaccination [ Time Frame: 1 day ]
Participants rate their intentions to take up the seasonal influenza vaccination on a 7-point likert scale, from strongly disagree (=1) to strongly agree (=7).
Original Primary Outcome Measures  ICMJE
 (submitted: September 5, 2020)
Intentions to take up the seasonal influenza vaccination [ Time Frame: 1 day ]
Participants rate their intentions to take up the seasonal influenza vaccination on a 7-point likert scale
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2020)
Intentions to wear a face mask [ Time Frame: Participants rate their intentions to take up a COVID-19 vaccination when one becomes available on a 7-point likert scale ]
Participants rate their intentions to wear a face mask in a store that does not require them to on a 7-point likert scale
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Influenza 2020/2021
Official Title  ICMJE Influenza 2020/2021. A Survey to Assess How People's Political Attitudes and Messages Influence Their Behavioral Intentions in the United Kingdom.
Brief Summary

As part of the fight against COVID-19, the UK government has announced its most comprehensive flu campaign to date (https://www.gov.uk/government/news/most-comprehensive-flu-programme-in-uk-history-will-be-rolled-out-this-winter). This should not be surpising: every year NHS hospitals experience an overwhelming number of influenza cases, and COVID-19 increases this concern. As in previous years, the flu vaccine is free at the point of care for people 65 and over. New this year is that later in the season the vaccine will be made available free at the point of care for people 50 and over. However, if people refuse to take the vaccine this comprehensive program cannot benefit public health.

The degree to which vaccine hesitancy is expressed varies across characteristics of the vaccine considered and the time and place it is offered, and across characteristics of the person's perceptions of complacency, convenience, confidence, calculations, and communal responsibility, i.e. the "5Cs". Information campaigns can be used to influence all 5Cs, and public facing information is often a necessary component of public health campaigns that may also include structural components. Largely, information campaigns can be viewed as a type of educational intervention.

Educational interventions may fall short of what is needed to alter people's intentions to vaccinate where they focus on system 1 rational thinking processes and neglect system 2 automatic thinking processes. To be more effective, public health messages must be tailored to align with the "beliefs, attitudes, and motivations" of the very people they intend to influence.

Fact-led educational interventions to increase parents' intentions to vaccinate their children are particularly ineffective where more subtle content opposes the recipient's deep-seated values. In a different context, recycling behaviour, previous research demonstrated that messages aligned with people's deep-seated values (i.e. the moral foundations that underlie political ideologies) are more likely to promote desired behavioural intentions than unaligned messages.

The present research expands the scope of previous research in two ways. First, rather than investigating parental attitudes towards vaccination, the investigators will look at people's intentions to self-vaccinate. Second, the investigators will explore the effectiveness of messages aligned with the moral foundations that underlie individual's political ideologies on their intentions to be vaccinated.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Condition  ICMJE Influenza Vaccine
Intervention  ICMJE Behavioral: Appeals
Written text motivating participants to take up the seasonal influenza vaccination
Study Arms  ICMJE
  • Experimental: Conservative - Binding Appeal
    Intervention: Behavioral: Appeals
  • Experimental: Liberal - Individulizing Appeal
    Intervention: Behavioral: Appeals
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 5, 2020)
200
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 21, 2020
Actual Primary Completion Date September 21, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Resident in England
  • Age 50+ years old, inclusive

The age criteria is set at 50+ years old, because this is the age group currently being advised by Public Health England to seek the flu jab as soon as possible this season. (https://www.gov.uk/government/news/most-comprehensive-flu-programme-in-uk-history-will-be-rolled-out-this-winter).

Exclusion Criteria:

  • Not a resident in England
  • Age less than 50 years old
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04546854
Other Study ID Numbers  ICMJE BSREC 167/19-20
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Kelly Ann Schmidtke, University of Warwick
Study Sponsor  ICMJE University of Warwick
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Warwick
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP