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
Funders
Funder type
Charity
Funder name
Cancer Research UK (CRUK) (UK) (ref: C16265)
Alternative name(s)
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
-
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.
-
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.