Condition category
Mental and Behavioural Disorders
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
01/04/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dh.gov.uk/Home/fs/en

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

  1. 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.

Additional files

Editorial Notes