Condition category
Respiratory
Date applied
17/03/2016
Date assigned
22/03/2016
Last edited
18/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Asking questions about a behaviour can change that behaviour – called the Question Behaviour Effect (QBE). The aim of this study is to test the QBE as a simple (and potentially cost effective) way to increase influenza vaccination rates among older adults. We will assess whether sending older adults a questionnaire about influenza vaccination increases vaccination rates.

Who can participate?
Patients who are eligible for an influenza vaccination by being age 65 or over at their next birthday

What does the study involve?
Participants are randomly allocated to one of eight groups: either to receive no questionnaire, or to receive a questionnaire measuring:
1. Demographics (i.e., asking whether they had children, their occupation, marital status, and ethnic origin)
2. Demographics plus items about intentions to get vaccinated and attitudes towards vaccination
3. Demographics plus items about intentions to get vaccinated and attitudes towards vaccination plus a post it note requesting questionnaire completion
4. Demographics plus items about anticipated regret about getting vaccinated, intentions to get vaccinated and attitudes towards vaccination
5. Demographics plus items about anticipated regret about getting vaccinated, intentions to get vaccinated and attitudes towards vaccination, plus a post it note requesting questionnaire completion
6. Demographics plus items about benefits of getting vaccinated, intentions to get vaccinated and attitudes towards vaccination
7. Demographics plus items about benefits of getting vaccinated, intentions to get vaccinated and attitudes towards vaccination, plus a post it note requesting questionnaire completion.
We tested the effects of these different questions on influenza vaccination rates.

What are the possible benefits and risks of participating?
The benefits of participating were helping inform the development of interventions to improve vaccination uptake. There were no risks of participating.

Where is the study run from?
General practices in the northern England, Leeds, UK area

When is the study starting and how long is it expected to run for?
July 2012 to February 2013

Who is funding the study?
Economic and Social Research Council (UK)

Who is the main contact?
Prof Mark Conner
m.t.conner@leeds.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Mark Conner

ORCID ID

http://orcid.org/0000-0002-6229-8143

Contact details

University of Leeds
School of Psychology
Leeds
LS2 9JT
United Kingdom
+44 (0)113 3435720
m.t.conner@leeds.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Varying cognitive targets and response rates to enhance the question-behavior effect: an eight-arm randomized controlled trial on influenza vaccination

Acronym

Study hypothesis

Asking questions about a behaviour can change that behaviour - the Question Behaviour Effect (QBE). The present research tested the QBE as a simple (and potentially cost effective) means to increase influenza vaccination rates among older adults. We tested the effects of different questions on influenza vaccination rates.

We also tested the effect of a manipulation (sticky post it note with request for help) designed to increase questionnaire response rates on influenza vaccination rates.

Ethics approval

NRES Committee Yorkshire and Humber - Bradford, 19/07/2011, 11/YH/0229

Study design

Interventional randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Prevention

Patient information sheet

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

Condition

Influenza

Intervention

There are eight arms. Participants in the control 1 (no questionnaire) condition did not receive a questionnaire. Participants in the control 2 (demographics questionnaire) condition received a questionnaire tapping whether they had children, their occupation, marital status, and ethnic origin. Participants in the other six conditions received a questionnaire tapping the same demographic questions plus questions about influenza vaccination. The first (intention + attitude condition) questionnaire contained items tapping intentions and attitudes in relation to influenza vaccination; the second (anticipated regret + intention + attitude condition) questionnaire additionally contained anticipated regret questions; the third (beneficence + intention + attitude condition) questionnaire additionally contained beneficence questions. The other three (intervention) questionnaires were the same, but had a sticky note attached to the front that included a message (‘Please take a few minutes to complete this for us. Thank you!’). The message was printed in blue on a yellow (72x72mm) sticky note but with the message appearing to be hand written.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Receiving an influenza vaccination in period 28/07/2012 to 07/02/2013 following invitation as indicated by records

Secondary outcome measures

None

Overall trial start date

28/07/2012

Overall trial end date

07/02/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Participants recruited from General Practices in the northern England, Leeds, UK area who were not taking part in a centralized influenza vaccination invitation scheme in Autumn 2012
2. The study population consisted of all patients in each practice eligible for an influenza vaccination that year by being age 65 years or over at their next birthday
3. A total of 13,806 patients were individually randomly assigned to one of eight conditions using a random number generator. Subsequently, 354 patients were deemed ineligible for vaccination (i.e., due to having left the General Practice, being deceased, unable to have a vaccination due to a medical condition, or having already received a vaccination) and excluded from the study, leaving 13,452 patients who were included in intention-to-treat analyses
4. A total of 4934 completed questionnaires (43.1%) were returned from 11752 sent out. The sample was 56.2% female with a mean age of 75.5 years (SD = 7.88) and mainly lived in areas of low deprivation (Townsend score M = -1.49, SD = 2.93). The eight different conditions were equivalent on gender and age but significantly different on deprivation

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

13,452

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/10/2012

Recruitment end date

29/11/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Leeds
c/o Mark Conner, Professor of Applied Social Psychology, School of Psychology
Leeds
LS2 9JT
United Kingdom

Sponsor information

Organisation

University of Leeds (UK)

Sponsor details

c/o Clare Skinner
Faculty Head of Research Support
Faculty of Medicine and Health
Worsley Building
Leeds
LS2 9LN
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Research council

Funder name

Economic and Social Research Council

Alternative name(s)

ESRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

A paper reporting the details of the study and key findings will be prepared during 2016.

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes