Simple versus informed choice invitations to screening
| ISRCTN | ISRCTN73125647 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73125647 |
| Secondary identifying numbers | 076838 |
- Submission date
- 23/12/2005
- Registration date
- 09/01/2006
- Last edited
- 21/12/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Theresa Marteau
Scientific
Scientific
Psychology Dept. (at Guy's)
Health Psychology Section
Psychology & Genetics Research Group
5th Floor Thomas Guy House
Guy's Campus
London Bridge
London
SE1 9RT
United Kingdom
| Phone | +44 (0)20 7188 0192 |
|---|---|
| theresa.marteau@kcl.ac.uk |
Study information
| Study design | Multicentre single-blind randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Didactic versus informed choice invitations to screening: balancing public health benefits and individual choice |
| Study acronym | DICISION |
| Study objectives | We propose to develop a feasible and effective informed choice strategy and to evaluate its impact on attendance at screening and motivation to follow subsequent advice, both overall and stratified by social deprivation. The work is set within the important public health context of screening for type two diabetes. We will test two hypotheses: 1. Uptake of screening for diabetes is higher following a traditional, didactic invitation compared with an informed choice invitation. 2. Amongst those who attend for screening, intentions to change behaviour to reduce risks are stronger following an informed choice invitation compared with a traditional invitation. |
| Ethics approval(s) | Cambridgeshire 1 Research Ethics Committee gave approval on the 5th May 2006 (ref: 06/Q0104/17) |
| Health condition(s) or problem(s) studied | Informed choice for screening for type two diabetes |
| Intervention | 1. Traditional invitation: This will be a brief letter based on previous invitations for screening tests, including diabetes and coronary heart disease. It will include: a. name of the condition i.e. type two diabetes b. aims of screening i.e. to reduce risks of diabetes and associated cardiovascular disease c. procedure i.e. review of risk including blood tests and clinical measures, advice and treatment as indicated 2. Informed choice invitation: This will comprise the same brief letter but with additional detailed information based on General Medical Council (GMC) guidelines, and linked to a self-administered informed choice aid based on similar tools successfully used to facilitate personal decisions in other health care contexts. |
| Intervention type | Other |
| Primary outcome measure | Uptake of screening, which will be recorded by the practice nurses conducting the screening. |
| Secondary outcome measures | 1. Intention to change behaviour to reduce risks of diabetes: behavioural intentions are good predictors of behaviour change. Three core behavioural intentions will be assessed in those attending: a. increasing physical activity b. restricting calories by eating low fat foods c. taking preventive medication, if indicated d. stopping smoking will also be assessed, when relevant 2. Self-reported behaviour assessed using standard questionnaires: a. physical activity b. diet c. smoking and use of medication to reduce risk of diabetes 3. Attendance for post screening blood tests and subsequent practice nurse advice will be recorded 4. Social deprivation: area (post code) and individual level measures (education, home ownership and access to car) will be used. Age, gender, and ethnic group and risk factors known before screening will also be recorded. 5. Risk stratification: all those attending will be given a risk score to indicate their risks of developing diabetes and experiencing a cardiovascular event over the next ten years. Those with confirmed diabetes, expected to be about 30 individuals, will also receive their Coronary Heart Disease (CHD) risk scores 6. Informed choice: choices to participate in screening will be classified as informed to the extent that they are based on understanding diabetes screening and reflect the decision-makers values, using a standardised method we have developed and validated in other screening contexts |
| Overall study start date | 01/01/2006 |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 1200 - but the study is sufficiently powered at 585 |
| Key inclusion criteria | 1. 1200 men and women aged 40 to 69 years 2. In the top 20% of risk of undiagnosed diabetes on practice registers, defined by a validated risk score applied to routine data on general practice population registers. The Cambridge Diabetes Risk Score includes the following risk variables: a. age b. gender c. family history of diabetes d. smoking status e. prescription of steroid or anti-hypertensive medication f. body mass index |
| Key exclusion criteria | Patients considered by the practice nurse or General Practitioner to be unsuitable for the project, for example, people who are severely ill, will be excluded from the study. |
| Date of first enrolment | 01/01/2006 |
| Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Psychology Dept. (at Guy's)
London
SE1 9RT
United Kingdom
SE1 9RT
United Kingdom
Sponsor information
King's College London (UK)
University/education
University/education
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
England
United Kingdom
| g.dale@iop.kcl.ac.uk | |
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
Charity
The Wellcome Trust (UK) (ref: 076838)
No information available
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 20/02/2009 | Yes | No | |
| Results article | results | 13/05/2010 | Yes | No | |
| Results article | results | 01/09/2011 | Yes | No |
