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
| ISRCTN | ISRCTN34254423 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34254423 |
| Secondary identifying numbers | N0530137082 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 01/04/2008
- 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
University College London
Department of Epidemiology
2-16 Torrington Place
London
WC1E 6BT
United Kingdom
| Phone | +44 (0)20 7679 1606 |
|---|---|
| hazel.gilbert@ucl.ac.uk |
Study information
| Study design | Randomised controlled trial - pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Scientific title | |
| Study objectives | The aim of the proposed research is to carry out a pilot study to assess the feasibility of, and response rates to, an intervention for smoking cessation. We have already developed a computer-based system for generating individually tailored feedback reports designed to encourage and help smokers to quit. These self-help materials tailored for each individual mimic the care used in clinical settings, but make this available to the general public. We plan to adapt this system for use in general practice, modifying the questionnaire and the feedback reports to different educational levels. The pilot work will lead to a large RCT evaluating the effectiveness of the intervention. The hypothesis to be tested on smokers identified from general practitioners lists is that: Personalised feedback reports tailored to levels of reading ability and sent to smokers in varying stages of readiness to quit, will increase quitting activity and modify the attitudes of the smokers over and above that found with usual standard care received from the practice. Please note that this trial was completed on the 30th June 2005. The previous end date for this pilot study was 31/05/2009. The main RCT of this pilot study has been registered under ISRCTN05385712 (see http://www.controlled-trials.com/ISRCTN05385712). |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Smoking addiction |
| Intervention | Questionnaires; Before-After-Study, Randomised Controlled Trial (RCT) comparison between: 1. Normal treatment 2. Normal treatment plus tailored feedback reports group |
| Intervention type | Other |
| Primary outcome measure | Computer tailored feedback, adapted to reading levels and readiness to quit, is a simple intervention which could be widely replicated and delivered cost effectively to a large proportion of the smoking population. A modest success rate could have a large effect on public health given its recruitment potential and make a valuable contribution to lowering smoking prevalence. The method mimics the guidelines of asking, advising, assessing, assisting and arranging and could be incorporated into GPs standard treatment at less time and cost. These materials, tailored to the requirements of each individual, would offer GPs and practice nurses an efficient way of integrating smoking cessation counselling into a busy primary care practice. The computer programme could also be made available on CD Rom to produce immediate printed feedback for use by primary care professionals. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/2004 |
| Completion date | 30/06/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | Four General Practices. 200 participants will be selected from each practice = 800 in total. |
| Key inclusion criteria | 1. Smokers 2. Aged between 18 and 65 years, either sex 3. Identified from records in four practices |
| Key exclusion criteria | Does not comply with above inclusion criteria |
| Date of first enrolment | 01/01/2004 |
| Date of final enrolment | 30/06/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University College London
London
WC1E 6BT
United Kingdom
WC1E 6BT
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
North Central London Research Consortium (UK)
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? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2007 | Yes | No |
