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

ISRCTN	ISRCTN84500365
DOI	https://doi.org/10.1186/ISRCTN84500365
Secondary identifying numbers	10736

Submission date: 17/08/2011
Registration date: 17/08/2011
Last edited: 21/03/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Tracy Sandberg
Scientific

Insitute of Psychological Sciences
Faculty of Health and Medicine
Leeds
LS2 9JT
United Kingdom

Email	t.m.sandberg@leeds.ac.uk

Study information

Study design	Randomised; Interventional; Design type: Prevention
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
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
Study objectives	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(s)	Bradford REC, 27/07/2011, ref: 11/YH/0229
Health condition(s) or problem(s) studied	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
Primary outcome measure	Uptake of flu jab for over 65s; timepoint(s): between September 2010 and March 2011
Secondary outcome measures	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 study start date	12/09/2011
Completion date	30/03/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Planned Sample Size: 15000; UK Sample Size: 15000; Description: Patients who are over 65 from participating GPs
Key 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
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	12/09/2011
Date of final enrolment	30/03/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Leeds

Leeds
LS2 9JT
United Kingdom

Sponsor information

University of Leeds (UK)
University/education

Insitute of Psychological Sciences
Faculty of Health and Medicine
Leeds
LS2 9JT
England
United Kingdom

Email	comms@esrc.ac.uk
"ROR"	https://ror.org/024mrxd33

Funders

Funder type

Research council

Economic and Social Research Council (ESRC) (UK) Grant Codes: RES 062 23 2220
Government organisation / National government

Alternative name(s): ESRC
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

21/03/2017: No publications found, verifying study status with principal investigator.