A primary care study of tailored advice for stopping smoking
| ISRCTN | ISRCTN05385712 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN05385712 |
| Secondary identifying numbers | BRD/06/022 |
- Submission date
- 04/01/2008
- Registration date
- 14/02/2008
- Last edited
- 06/01/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Hazel Gilbert
Scientific
Scientific
Department of Primary Care and Population Sciences
University College London (UCL)
Hamstead Campus
Rowland Hill Street
London
NW3 2PF
United Kingdom
| Phone | +44 (0)20 7317 7548 |
|---|---|
| hazel.gilbert@ucl.ac.uk |
Study information
| Study design | Randomised single centre controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Effectiveness of computer tailored Smoking Cessation Advice in Primary carE: a randomised trial |
| Study acronym | ESCAPE |
| Study objectives | Personally tailored feedback reports, based on an assessment of individual needs and tailored to levels of reading ability, sent to smokers identified from general practitioner (GP) lists with varying levels of motivation and readiness to quit, will increase quit rates and quitting activity over and above that found with standard self help and usual care received from the practice. The study objectives are: 1. To compare the effectiveness of sending personalised computer tailored feedback reports to smokers with sending standard self-help materials 2. To explore the effectiveness of tailored feedback reports by socio-economic status to determine their effect in more deprived groups 3. To determine the characteristics of smokers who are prompted to change their behaviour after receiving tailored feedback reports Please note that the pilot study to this randomised trial was assigned an ISRCTN in 2004. This was assigned to ISRCTN34254423: Pilot trial to assess the feasibility and response rates for an RCT evaluating the effectiveness of a computer tailored intervention for smoking cessation in general practice (see http://www.controlled-trials.com/ISRCTN34254423). As of 15/07/2009 this record was updated to include an extended anticipated end date; the initial end date at the time of registration was 31/12/2008. |
| Ethics approval(s) | Northern and Yorkshire Multicentre Research Ethics Committee (MREC) approved on the 19th April 2006 (ref: 06/MRE03/10). |
| Health condition(s) or problem(s) studied | Smoking cessation |
| Intervention | The control group will receive the usual care plus standard information. Participants will be assessed at baseline and sent standard non-tailored information (NHS Smokefree booklet), as well as receiving the usual care offered by their general practice. The control group receive only one mailing on receipt of their completed baseline questionnaire. The intervention group will receive usual care plus standard information plus computer-tailored feedback reports based on the information obtained at baseline. The intervention group receives an additional assessment and personal report one month after the baseline. The follow up is 6 months after baseline. |
| Intervention type | Other |
| Primary outcome measure | Prolonged abstinence for 1 month and for 3 months at the 6-month follow-up. Outcomes will be measured by postal questionnaire. Non-respondents to questionnaires will receive one postal reminder. Non-respondents to the reminder will be contacted by telephone. In order to estimate the accuracy of self-reports, a random sample of 20% of the participants who report abstinence will have their status validated by salivary cotinine sample, obtained by post. |
| Secondary outcome measures | 1. 24 hour and 7 day point-prevalence abstinence 2. Quit attempts 3. Changes in motivation and intention to quit 4. Cognitions measured at baseline 5. Use of Nicotene Replacement Therapy (NRT) or Zyban 6. Any contact with advice services or health professionals (group, clinic, telephone, or face-to-face) 7. Use of NHS resources and other smoking cessation aids for economic analysis Process measures: 1. Adherence to advice 2. Perceptions of the feedback reports 3. Perceived personal relevance of the feedback reports Information from General Practices: Performance against target figures set by PCTs before and after the intervention as indicators of activity |
| Overall study start date | 01/07/2007 |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 7250 |
| Key inclusion criteria | All current cigarette smokers aged 18 to 65, either sex, able to read English will be eligible for inclusion in the study. |
| Key exclusion criteria | Exclusion criteria are minimal because the aim is to recruit all smokers. However, any patients selected who are considered by the GP to be unsuitable for the project, e.g., people with severe mental impairment or severely or terminally ill, will be excluded. |
| Date of first enrolment | 01/07/2007 |
| Date of final enrolment | 31/12/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Primary Care and Population Sciences
London
NW3 2PF
United Kingdom
NW3 2PF
United Kingdom
Sponsor information
University College London (UCL) (UK)
University/education
University/education
Hamstead Campus
Rowland Hill Street
London
NW3 2PF
England
United Kingdom
| Phone | +44 (0)20 7794 6329 |
|---|---|
| o.avwenagha@medsch.ucl.ac.uk | |
| Website | http://www.ucl.ac.uk/ |
"ROR" |
https://ror.org/02jx3x895 |
Funders
Funder type
Charity
Cancer Research UK (CRUK) (UK) (ref: C16265)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2012 | Yes | No | |
| Results article | results | 01/04/2013 | Yes | No |
