Contact information
Type
Scientific
Primary contact
Dr Hazel Gilbert
ORCID ID
Contact details
University College London
Department of Epidemiology
2-16 Torrington Place
London
WC1E 6BT
United Kingdom
+44 (0)20 7679 1606
hazel.gilbert@ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0530137082
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial - pilot study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/01/2004
Overall trial end date
30/06/2005
Reason abandoned
Eligibility
Participant inclusion criteria
1. Smokers
2. Aged between 18 and 65 years, either sex
3. Identified from records in four practices
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Four General Practices. 200 participants will be selected from each practice = 800 in total.
Participant exclusion criteria
Does not comply with above inclusion criteria
Recruitment start date
01/01/2004
Recruitment end date
30/06/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University College London
London
WC1E 6BT
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
North Central London Research Consortium (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2007 results on http://www.ncbi.nlm.nih.gov/pubmed/17584974
Publication citations
-
Results
Gilbert H, Nazareth I, Sutton S, Assessing the feasibility of proactive recruitment of smokers to an intervention in general practice for smoking cessation using computer-tailored feedback reports., Fam Pract, 2007, 24, 4, 395-400, doi: 10.1093/fampra/cmm028.