Trial Review

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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
Type of registration
Prospectively registered

Titles & IDs
Public title
Who cares? Pandemic influenza risk perception in urban populations of England and Wales
Scientific title
Who cares? A quantitative study of pandemic influenza risk perception in urban populations of England and Wales
Secondary ID [1] 298019 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza 312468 0
Risk perception 312469 0
Pandemic influenza 312470 0
Condition category
Condition code
Public Health 311018 311018 0 0
Other public health
Infection 311198 311198 0 0
Other infectious diseases
Respiratory 311199 311199 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 314249 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319814 0
Risk perception of pandemic influenza in urban populations as assessed by study-specific questionnaire
Timepoint [1] 319814 0
Cross-sectional cohort during the data collection period
Secondary outcome [1] 369987 0
Knowledge of the symptoms, signs and cause of influenza through study-specific questionnaire
Timepoint [1] 369987 0
Cross-sectional cohort during the data collection period

Eligibility
Key inclusion criteria
1. Adult participants presenting to each study site
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
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.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
31/07/2019
Actual
31/07/2019
Date of last participant enrolment
Anticipated
11/10/2019
Actual
18/10/2019
Date of last data collection
Anticipated
Actual
18/10/2019
Sample size
Target
400
Accrual to date
Final
220
Recruitment outside Australia
Country [1] 21423 0
United Kingdom
State/province [1] 21423 0
London, England
Country [2] 21424 0
United Kingdom
State/province [2] 21424 0
Cardiff, Wales

Funding & Sponsors
Funding source category [1] 302544 0
Self funded/Unfunded
Name [1] 302544 0
Dr Tecwyn Davies
Country [1] 302544 0
Denmark
Funding source category [2] 302545 0
University
Name [2] 302545 0
University of Copenhagen
Country [2] 302545 0
Denmark
Primary sponsor type
University
Name
Dr Tecwyn Davies
Address
COPE
University of Copenhagen (CSS Campus)
Øster Farimagsgade 5, Building 22
1014. Copenhagen K
Country
Denmark
Secondary sponsor category [1] 302454 0
University
Name [1] 302454 0
Associate Professor Dan Wolf Meyrowitsch
Address [1] 302454 0
Global Health Section
Øster Farimagsgade 5, bg. 9, opg. P, CSS, bygn. 9, Building: 9.2.14
Postboks 209
1014 København K,
Country [1] 302454 0
Denmark

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303190 0
London - Westminster Research Ethics Committee
Ethics committee address [1] 303190 0
Ethics committee country [1] 303190 0
United Kingdom
Date submitted for ethics approval [1] 303190 0
25/06/2019
Approval date [1] 303190 0
24/07/2019
Ethics approval number [1] 303190 0
19/LO/1227

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92802 0
Dr Tecwyn Davies
Address 92802 0
C.O.P.E.
University of Copenhagen (CSS Campus),
Øster Farimagsgade 5, Building 22,
1014. Copenhagen K
Country 92802 0
Denmark
Phone 92802 0
+4550333318
Fax 92802 0
Email 92802 0
szn442@alumni.ku.dk
Contact person for public queries
Name 92803 0
Tecwyn Davies
Address 92803 0
C.O.P.E.
University of Copenhagen (CSS Campus),
Øster Farimagsgade 5, Building 22,
1014. Copenhagen K
Country 92803 0
Denmark
Phone 92803 0
+4550333318
Fax 92803 0
Email 92803 0
szn442@alumni.ku.dk
Contact person for scientific queries
Name 92804 0
Tecwyn Davies
Address 92804 0
C.O.P.E.
University of Copenhagen (CSS Campus),
Øster Farimagsgade 5, Building 22,
1014. Copenhagen K
Country 92804 0
Denmark
Phone 92804 0
+4550333318
Fax 92804 0
Email 92804 0
szn442@alumni.ku.dk

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3845Informed consent form  szn442@alumni.ku.dk



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.