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
Prevention
Patient information sheet
Not available in web format, please use the contact details 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
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
University of Leeds
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
government organisation
Funding Body Subtype
Federal/National Government
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