Condition category
Mental and Behavioural Disorders
Date applied
04/01/2008
Date assigned
14/02/2008
Last edited
06/01/2014
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

Department of Primary Care and Population Sciences
University College London (UCL)
Hamstead Campus
Rowland Hill Street
London
NW3 2PF
United Kingdom
+44 (0)20 7317 7548
hazel.gilbert@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

BRD/06/022

Study information

Scientific title

Effectiveness of computer tailored Smoking Cessation Advice in Primary carE: a randomised trial

Acronym

ESCAPE

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).

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

Northern and Yorkshire Multicentre Research Ethics Committee (MREC) approved on the 19th April 2006 (ref: 06/MRE03/10).

Study design

Randomised single centre controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Smoking cessation

Intervention

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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 measures

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

Overall trial start date

01/07/2007

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

All current cigarette smokers aged 18 to 65, either sex, able to read English will be eligible for inclusion in the study.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

7250

Participant 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.

Recruitment start date

01/07/2007

Recruitment end date

31/12/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

University College London (UCL) (UK)

Sponsor details

Hamstead Campus
Rowland Hill Street
London
NW3 2PF
United Kingdom
+44 (0)20 7794 6329
o.avwenagha@medsch.ucl.ac.uk

Sponsor type

University/education

Website

http://www.ucl.ac.uk/

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK) (ref: C16265)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

1. 2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22385924
2. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23072513

Publication citations

  1. Results

    Gilbert HM, Sutton SR, Leurent B, Alexis-Garsee C, Morris RW, Nazareth I, Characteristics of a population-wide sample of smokers recruited proactively for the ESCAPE trial., Public Health, 2012, 126, 4, 308-316, doi: 10.1016/j.puhe.2011.11.010.

  2. Results

    Gilbert HM, Leurent B, Sutton S, Alexis-Garsee C, Morris RW, Nazareth I, ESCAPE: a randomised controlled trial of computer-tailored smoking cessation advice in primary care., Addiction, 2013, 108, 4, 811-819, doi: 10.1111/add.12005.

Additional files

Editorial Notes