Condition category
Infections and Infestations
Date applied
06/09/2012
Date assigned
10/09/2012
Last edited
10/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims:
During the swine flu pandemic in 2009/10, the British Government used a large advertising campaign to ask members of the public to do several different things to help reduce the spread of illness. These included washing hands more often, taking medicines such as ‘Tamiflu’ if ill and, for some people, being vaccinated. To check how many people were doing these things and what impact their adverts were having, the Government and academic researchers conducted several telephone surveys during the pandemic. These surveys were very useful. However, because they had to be put together quickly, there was room for improvement in the questions that were asked. In this research, we will spend some time before the next pandemic thinking about what questions to ask in future surveys and checking that the questions make sense to members of the public.
We will be conducting two, linked, studies. In the first, we will use a series of interviews with volunteers from the public to test out the wording for our new questions and check that they are clear and unambiguous. In the second, we will ask a professional market research company to conduct a telephone survey with randomly selected members of the public, to test whether our questions work during a normal flu season. By surveying the same members of the public at two time points, one week apart, we will be able to tell whether our questions result in the same answers when they are repeated. This is a good test of whether a particular question works properly.

Who can participate?
Anyone can participate in either study if they aged 18 or over and speak English fluently. People will also be able to complete our survey study in Welsh, if they prefer.

What does the study involve?
The “interview” study involves taking part in one interview that will last around one hour. This will be done over the telephone. During the interview, we will read out the questions that we have written for our new survey. The participant will answer the questions and also to explain why they have given that particular answer. For example, if we ask “How worried are you about catching flu on a scale of 1 (not at all) to 5 (very worried),” we would like to know where the participant puts themselves on that scale and also why. Sometimes, we will also ask a participant to repeat a question back to us, but in their own words. We will do this to check whether the question makes sense to them. We would also like participants to tell us if they spot any problems with a question, such as a piece of jargon that people might not understand or a question that seems vague or difficult to answer. Any feedback on the questions will be very welcome.
In the “survey” study, the market research company will use a process called ‘random digit dialling’ to randomly select telephone numbers to call. People who answer the telephone will be asked if they are willing to take part in a survey concerning flu. If they are happy to proceed, they will be asked to answer our new questions about flu. They will then be called back one week later and asked to answer the same questions again. Each interview will take about 15 minutes to complete.

What are the possible benefits and risks of participating?
There are no major benefits or risks associated with taking part in either study. Because taking part in our cognitive interviews may be lengthy (around an hour), we will give participants in that study £20 as a thank you.

Where is the study run from?
King’s College London (UK)

When is study starting and how long is it expected to run for?
The study will start recruiting participants for the interviews on 1 October 2012. The interviews will take place over the space of two months. The telephone surveys will be run during January and February 2013.

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
G James Rubin
gideon.rubin@kcl.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr James Rubin

ORCID ID

Contact details

King's College London
Department of Psychlogical Medicine
Weston Education Centre
Cutcombe Road
London
SE3 7QH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

11/46/21

Study information

Scientific title

Evaluating and improving communication with the public during a pandemic, using rapid turn-around telephone surveys

Acronym

FluTEST

Study hypothesis

1. To select outcome measures for a new telephone survey that will allow researchers and policy makers to track the uptake of key behavioural recommendations among the general public during a future influenza pandemic
2. To select predictor variables for these outcomes that are well-grounded in psychological theory and are amenable to change using a multimedia communications campaign
3. To test and refine the clarity and reliability of the outcome and predictor variables during a normal influenza season
4. To test the feasibility of using a sampling strategy for the telephone survey that incorporates a prospective design

More details can be found at http://www.hta.ac.uk/project/2889.asp

Ethics approval

King's College London Psychiatry, Nursing and Midwifery Research Ethics Committee, 25 July 2012, ref: PNM/11/12-139

Study design

Cognitive interviews to test questionnaire wording, and one cross-sectional telephone survey of the general public, using random digit dial, followed by a one-week follow-up of the same sample.

Primary study design

Observational

Secondary study design

Cross-section survey

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Influenza

Intervention

Cognitive Interviews: Up to three rounds of cognitive interviews will be used to test our newly developed items for their comprehensibility, face validity and usability in the context of a telephone interview. Participants will be asked to take part in a telephone interview. They will be read each item in turn, asked to provide their answer and asked to explain the reasoning behind their response. Where required, they will also be asked to explain what they believe the question is asking and / or to suggest an alternative wording for the question. This process will allow us to assess the comprehensibility and usability of the questions. By assessing whether participant perceptions of the meaning of items matches our own interpretation of them, we will also be able to assess the face validity of the items. Items which are identified as being difficult to understand or answer will be reworded. These revisions will then be tested in the next round of interviews.

Telephone surveys: After we have produced a list of useable predictor and outcome variable items, we will test these further in a telephone survey of a representative sample of the general population of Britain, with a follow-up survey of the same sample occurring seven days later. We will use the first survey to assess the factor structure and internal consistency of any scales and to produce baseline data for eventual comparison against data collected during a pandemic. We will use the follow-up survey to assess the test-retest reliability of our items and scales, and to assess the possible non-response bias associated with a follow-up survey in this context. The first survey will be conducted during a normal flu season and will use random digit dialling and proportional quota sampling, with quotas based on the most recent Census data for age, gender, geographical region and social grade.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Our primary outcomes are the reliability and validity of our new questionnaire measures. We will use exploratory factor analysis to assess the clustering of those items that we intend to use as scales using data derived from the first survey. Internal reliability of scales will be tested using Cronbach’s alphas, item-total correlations and inter-item correlations. Test-retest reliability will be calculated using intra-class coefficients and weighted Kappa coefficients.

Secondary outcome measures

We will assess predictors of non-response for our follow-up survey

Overall trial start date

01/10/2012

Overall trial end date

01/03/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Participants must be aged 18 or over and able to speak English.
2. Participants will also be able to complete our telephone survey in Welsh, if they prefer.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Cognitive interviews: 30 to 90 participants. Telephone survey: 1,067

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/10/2012

Recruitment end date

01/03/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

King's College London
London
SE3 7QH
United Kingdom

Sponsor information

Organisation

King's College London (UK)

Sponsor details

Strand
London
WC2R 2LS
United Kingdom

Sponsor type

University/education

Website

http://www.kcl.ac.uk/

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK) ref: 11/46/21

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in http://www.ncbi.nlm.nih.gov/pubmed/25642523

Publication citations

Additional files

Editorial Notes

10/03/2016: Publication reference added.