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 |
| Protocol serial number | 10736 |
| Sponsor | University of Leeds (UK) |
| Funder | Economic and Social Research Council (ESRC) (UK) Grant Codes: RES 062 23 2220 |
- 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
Scientific
Insitute of Psychological Sciences
Faculty of Health and Medicine
Leeds
LS2 9JT
United Kingdom
| t.m.sandberg@leeds.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised; Interventional; Design type: Prevention |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Uptake of flu jab for over 65s; timepoint(s): between September 2010 and March 2011 |
| Key secondary outcome measure(s) |
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). |
| Completion date | 30/03/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 15000 |
| 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
- United Kingdom
- England
Study participating centre
University of Leeds
Leeds
LS2 9JT
United Kingdom
LS2 9JT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
21/03/2017: No publications found, verifying study status with principal investigator.
