Condition category
Infections and Infestations
Date applied
17/08/2011
Date assigned
17/08/2011
Last edited
03/07/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Tracy Sandberg

ORCID ID

Contact details

Insitute of Psychological Sciences
Faculty of Health and Medicine
Leeds
LS2 9JT
United Kingdom
t.m.sandberg@leeds.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

10736

Study information

Scientific title

Understanding and using self-generated validity to promote behaviour change: a randomised trial on increasing uptake of the seasonal flu jab for the over 65s

Acronym

Study hypothesis

To further our understanding of a phenomena called Self-Generated Validity (SGV) or the Mere Measurement Effect, and use it to promote attendance for the flu jab amongst the over 65s. The SGV refers to the fact that when people are asked to report their intentions to perform a behaviour, they are subsequently more likely to perform the actual behaviour than if they didn’t report their intentions. This study investigates the optimum conditions needed to produce the strongest effect. These can then be incorporated into future campaigns.

Ethics approval

Bradford REC, 27/07/2011, ref: 11/YH/0229

Study design

Randomised; Interventional; Design type: Prevention

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Screening

Patient information sheet

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

Condition

Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases

Intervention

The interventions relate to patients being assigned to one of eight conditions and receiving one set of the following:
Group 1 – standard invite materials only (control 1)
Group 2 – short questionnaire to tap demographics (age, ethnicity, social class) (control 2)
Group 3 – intention and attitude items (experimental 1) plus demographics
Group 4 – as Group 3 but with post-it (intervention to increase return rate) (experimental 2) plus demographics. Post-it refers to the sticky notes which will be attached to some of the questionnaires to see if there is a difference in return rates between those questionnaires which have them and those which do not.
Group 5 – regret, intention and attitude items (experimental 3) plus demographics
Group 6 – regret, intention and attitude items with post-it (experimental 4) plus demographics
Group 7 – beneficence, intention and attitude items (experimental 5) plus demographics
Group 8 – beneficence, intention and attitude items with post-it (experimental 6) plus demographics

It is predicted that there will a 'dose response' effectiveness of SGV as detailed below:-
1. Conditions 3-8 will be more effective than conditions 1-2
2. Condition 5 will more effective than condition 3 (adding anticipated regret)
3. Condition 6 will more effective than condition 5 (use of post-it will promote return rate and therefore the engagement with the questionnaire necessary for the optimum effect)
4. Condition 4 will be more effective than condition 3 (as above)
5. Condition 8 will be more effective than condition 7 (as above)
6. Condition 7 will be more effective than condition 3 (adding beneficence)
7. SGV effect will not vary depending on socio-economic status

The research hopes to identify the best way to maximise uptake of the flu jab using SGV.

Intervention type

Other

Phase

Phase I

Drug names

Primary outcome measures

Uptake of flu jab for over 65s; timepoint(s): between September 2010 and March 2011

Secondary outcome measures

We will also assess duration from invite to uptake in days. Differences in attendance rates by condition, social class and their interaction will also be analysed, as well as the impacts on time delay to uptake. Given that SGV effects may only operate in those completing questionnaires, secondary analysis will examine differences in condition among those who returned completed questionnaires. Analysis will also examine the impact of questionnaire responses on attendance rates within conditions (e.g., is attendance higher among those with stronger intentions to attend).

Overall trial start date

12/09/2011

Overall trial end date

30/03/2012

Reason abandoned

Eligibility

Participant inclusion criteria

All patients over 65 registered with participating general practitioners (GPs) who are being sent their annual flu jab invite; Target Gender: Male & Female; Lower Age Limit 65 no age limit or unit specified

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 15000; UK Sample Size: 15000; Description: Patients who are over 65 from participating GPs

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

12/09/2011

Recruitment end date

30/03/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Insitute of Psychological Sciences
Leeds
LS2 9JT
United Kingdom

Sponsor information

Organisation

University of Leeds (UK)

Sponsor details

Insitute of Psychological Sciences
Faculty of Health and Medicine
Leeds
LS2 9JT
United Kingdom
comms@esrc.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Research council

Funder name

Economic and Social Research Council (ESRC) (UK) Grant Codes: RES 062 23 2220

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

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes