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| A primary care study of tailored advice for stopping smoking |
| Source of record | UK Trials |
| ISRCTN | ISRCTN05385712 |
| Date ISRCTN assigned | 14/02/2008 |
| Local reference number(s) | BRD/06/022 |
| Public title | A primary care study of tailored advice for stopping smoking |
| Scientific title | Effectiveness of computer tailored Smoking Cessation Advice in Primary carE: a randomised trial |
| Acronym | ESCAPE |
| Disease/condition/study domain | Smoking cessation |
| Study hypothesis | 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). |
| Design/methodology | Randomised, single centre, controlled trial |
| Research ethics review | Ethics approval received from the Northern and Yorkshire Multicentre Research Ethics Committee (MREC) on the 19th April 2006 (ref: 06/MRE03/10). |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | All current cigarette smokers aged 18 to 65, either sex, able to read English will be eligible for inclusion in the study. |
| Participants - 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. |
| Patient information material | |
| Anticipated start date | 01/07/2007 |
| Anticipated end date | 31/12/2008 |
| Status of trial | Ongoing |
| Target number of participants | 7250 |
| Interventions | 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. |
| Primary outcome measure(s) | 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 measure(s) | 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 |
| Sources of funding | Cancer Research UK (CRUK) (UK) (ref: C16265) |
| Sponsor name | University College London (UCL) (UK) |
| Sponsor details | Hamstead Campus Rowland Hill Street London United Kingdom NW3 2PF |
| Sponsor telephone | +44 (0)20 7794 6329 |
| Sponsor email | o.avwenagha@medsch.ucl.ac.uk |
| Sponsor website | http://www.ucl.ac.uk/ |
| Contact name | Dr Hazel Gilbert |
| Contact details | Department of Primary Care and Population Sciences University College London (UCL) Hamstead Campus Rowland Hill Street London United Kingdom NW3 2PF |
| Contact telephone | +44 (0)20 7317 7548 |
| Contact email | hazel.gilbert@ucl.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN05385712 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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