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Trial registered on ANZCTR
Registration number
ACTRN12619000672156
Ethics application status
Approved
Date submitted
18/04/2019
Date registered
6/05/2019
Date last updated
22/04/2020
Date data sharing statement initially provided
6/05/2019
Date results information initially provided
22/04/2020
Type of registration
Prospectively registered
Titles & IDs
Public title
Who cares? Pandemic influenza risk perception in urban populations of England and Wales
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Scientific title
Who cares? A quantitative study of pandemic influenza risk perception in urban populations of England and Wales
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Secondary ID [1]
298019
0
Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Influenza
312468
0
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Risk perception
312469
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Pandemic influenza
312470
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Condition category
Condition code
Public Health
311018
311018
0
0
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Other public health
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Infection
311198
311198
0
0
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Other infectious diseases
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Respiratory
311199
311199
0
0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
A cross-sectional, quantitative, questionnaire-based survey of the risk perception of participants in England (London) and Wales (Cardiff).
Questionnaires will be self-completed and provided to each adult presenting to the study sites. It is expected that the questionnaire will take no more than 20 minutes to complete
No follow-up will be planned. No physical or clinical intervention will take place.
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Intervention code [1]
314249
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Not applicable
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
319814
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Risk perception of pandemic influenza in urban populations as assessed by study-specific questionnaire
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Assessment method [1]
319814
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Timepoint [1]
319814
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Cross-sectional cohort during the data collection period
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Secondary outcome [1]
369987
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Knowledge of the symptoms, signs and cause of influenza through study-specific questionnaire
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Assessment method [1]
369987
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Timepoint [1]
369987
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Cross-sectional cohort during the data collection period
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Eligibility
Key inclusion criteria
1. Adult participants presenting to each study site
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Minimum age
16
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- Age less than 16 years old
- Unable or unwilling to consent
- Having participated in the study previously
- Having knowledge of friends or family that have taken-part in the study
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Study design
Purpose
Psychosocial
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Duration
Cross-sectional
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Selection
Convenience sample
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Timing
Prospective
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Statistical methods / analysis
Using the Raosoft sample size calculator, a sample size of 385 participants was obtained (using a confidence interval of 95%, margin of error 5% and power of 80%).
Considering an additional 20% to this sample size to account for incomplete data (n = 392), the
target sample size would be 400.
Data analysis will be carried out using SPSS (Statistical Package for Social Sciences) using a confidence interval of 95% and P-value of 0.05.
Multivariate analysis would be performed using the independent variables including age, gender, level of education, concurrent health problems and the dependent variables including the risk perception as rated on the 5-point Likert-scale.
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Recruitment
Recruitment status
Stopped early
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Data analysis
Data analysis is complete
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Reason for early stopping/withdrawal
Participant recruitment difficulties
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Date of first participant enrolment
Anticipated
31/07/2019
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Actual
31/07/2019
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Date of last participant enrolment
Anticipated
11/10/2019
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Actual
18/10/2019
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Date of last data collection
Anticipated
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Actual
18/10/2019
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Sample size
Target
400
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Accrual to date
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Final
220
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Recruitment outside Australia
Country [1]
21423
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United Kingdom
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State/province [1]
21423
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London, England
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Country [2]
21424
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United Kingdom
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State/province [2]
21424
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Cardiff, Wales
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Funding & Sponsors
Funding source category [1]
302544
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Self funded/Unfunded
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Name [1]
302544
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Dr Tecwyn Davies
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Address [1]
302544
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COPE
University of Copenhagen (CSS Campus)
Øster Farimagsgade 5, Building 22
1014. Copenhagen K
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Country [1]
302544
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Denmark
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Funding source category [2]
302545
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University
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Name [2]
302545
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University of Copenhagen
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Address [2]
302545
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COPE
University of Copenhagen (CSS Campus)
Øster Farimagsgade 5, Building 22
1014. Copenhagen K
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Country [2]
302545
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Denmark
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Primary sponsor type
University
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Name
Dr Tecwyn Davies
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Address
COPE
University of Copenhagen (CSS Campus)
Øster Farimagsgade 5, Building 22
1014. Copenhagen K
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Country
Denmark
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Secondary sponsor category [1]
302454
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University
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Name [1]
302454
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Associate Professor Dan Wolf Meyrowitsch
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Address [1]
302454
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Global Health Section
Øster Farimagsgade 5, bg. 9, opg. P, CSS, bygn. 9, Building: 9.2.14
Postboks 209
1014 København K,
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Country [1]
302454
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Denmark
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
303190
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London - Westminster Research Ethics Committee
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Ethics committee address [1]
303190
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Health Research Authority,
Ground Floor, Skipton House,
80 London Road,
London.
SE1 6LH
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Ethics committee country [1]
303190
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United Kingdom
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Date submitted for ethics approval [1]
303190
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25/06/2019
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Approval date [1]
303190
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24/07/2019
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Ethics approval number [1]
303190
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19/LO/1227
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Summary
Brief summary
The flu is a viral illness that affects many people every year around the world. The World Health Organisation (WHO) categorises the flu as one of the 10 biggest threats to human health in 2019. As it is spread from person to person, attempts to reduce the number of people that get infected is important. This is even more important when lots of people unexpectedly become very sick at the same time, and many of those who become sick die..
The study aims to investigate how and what people decide is a risk to their health. In particular, whether people see influenza (‘the flu’) as a major risk or not, and what things are taken into consideration. The information we collect will be used to see if there are any patterns in the decisions people make and maybe why.
If we can better understand what people know about the flu and how bad they think it is or can be, it could help to improve public education and hopefully reduce the chance of people catching it or becoming very sick with the flu in the future.
We will ask 400 people to take-part and complete a questionnaire, which should take no more than 10 minutes. All answers will be completely anonymous and unidentifiable. Once the study has been finished, the results can be shared with everyone who took part if they wish.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Tecwyn Davies
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Address
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C.O.P.E.
University of Copenhagen (CSS Campus),
Øster Farimagsgade 5, Building 22,
1014. Copenhagen K
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Country
92802
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Denmark
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Phone
92802
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+4550333318
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Fax
92802
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Email
92802
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[email protected]
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Contact person for public queries
Name
92803
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Dr Tecwyn Davies
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Address
92803
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C.O.P.E.
University of Copenhagen (CSS Campus),
Øster Farimagsgade 5, Building 22,
1014. Copenhagen K
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Country
92803
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Denmark
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Phone
92803
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+4550333318
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Fax
92803
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Email
92803
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[email protected]
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Contact person for scientific queries
Name
92804
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Dr Tecwyn Davies
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Address
92804
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C.O.P.E.
University of Copenhagen (CSS Campus),
Øster Farimagsgade 5, Building 22,
1014. Copenhagen K
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Country
92804
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Denmark
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Phone
92804
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+4550333318
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Fax
92804
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Email
92804
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
3845
Informed consent form
[email protected]
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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