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

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
Email hazel.gilbert@ucl.ac.uk

Study information

Study designRandomised single centre controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleEffectiveness of computer tailored Smoking Cessation Advice in Primary carE: a randomised trial
Study acronymESCAPE
Study objectivesPersonally 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) studiedSmoking cessation
InterventionThe 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 typeOther
Primary outcome measureProlonged 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 measures1. 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 date01/07/2007
Completion date31/12/2009

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants7250
Key inclusion criteriaAll current cigarette smokers aged 18 to 65, either sex, able to read English will be eligible for inclusion in the study.
Key exclusion criteriaExclusion 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 enrolment01/07/2007
Date of final enrolment31/12/2009

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Primary Care and Population Sciences
London
NW3 2PF
United Kingdom

Sponsor information

University College London (UCL) (UK)
University/education

Hamstead Campus
Rowland Hill Street
London
NW3 2PF
England
United Kingdom

Phone +44 (0)20 7794 6329
Email o.avwenagha@medsch.ucl.ac.uk
Website http://www.ucl.ac.uk/
ROR logo "ROR" https://ror.org/02jx3x895

Funders

Funder type

Charity

Cancer Research UK (CRUK) (UK) (ref: C16265)
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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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