Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A randomised controlled trial to assess the feasibility, acceptability and effectiveness of tailored web- and text-based facilitation of smoking cessation in primary care
Acronym
Study hypothesis
The proposed trial is part of a larger programme of work in the General Practice and Primary Care Research Unit, University of Cambridge, on computer-based approaches to smoking cessation. The intervention to be evaluated in this trial consists of two components:
1. A web-based program designed to be used by a practice nurse or other smoking cessation advisor (SCA); the program generates a cessation advice report that is highly tailored to relevant characteristics of the smoker
2. A three-month program of automatically generated tailored text messages sent to the smokers mobile phone
The iQuit program is a potentially cost-effective approach which is designed to enhance the effectiveness of the consultation without requiring nurses to radically change the way they advise and treat smokers and to provide continuing support to smokers during their quit attempts, while reducing the need for them to attend the practice (except for the purpose of obtaining further supplies of nicotine replacement and attending for the routine NHS four-week follow-up appointment).
Ethics approval
Not provided at time of registration
Study design
Two parallel group randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Smoking cessation
Intervention
Two groups to be compared:
1. Control group: participants will receive 'usual care' for smoking cessation
2. Intervention group: participants will receive 'usual care' for smoking cessation, plus a printed patient-tailored advice report generated by web-based software, followed by a 90-day program of patient-tailored interactive SMS text messages
Follow up dates:
Routine NHS follow up: 4 weeks from quit date
Research follow up: 8 weeks and 6 months from randomisation date
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Self-reported effectiveness, using a self report of being abstinent from smoking for at least 2 weeks, at 8-week follow-up from randomisation date, as assessed by postal questionnaire or telephone interview (blinded interviewer).
Secondary outcome measures
1. Carbon monoxide (CO)-verified self-report of being abstinent from smoking for at least 2 weeks, at 4-week follow-up from quit date
2. Self-reported prolonged abstinence (at least 3 months) at 6-month follow-up from randomisation date
Overall trial start date
01/04/2009
Overall trial end date
31/01/2011
Reason abandoned
Eligibility
Participant inclusion criteria
Patients can be included in the study if they meet all of the criteria below:
1. Current smoker (has smoked in the 7 days prior to randomisation date)
2. Able to read English and can provide written informed consent
3. Is seriously considering quitting smoking and is willing to set a quit date within the 14 days after randomisation
4. Aged 18 - 75 years, either sex
5. Has a mobile phone and is familiar with sending and receiving SMS text messages
6. Is willing to participate in study and follow study procedures
7. Is not currently enrolled in another formal smoking cessation study or program
8. Is not using nicotene replacement therapy (NRT), bupropion (Zyban®) and varenicline (Champix®) or other pharmacotherapy at randomisation date
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Total approx 600 (300 in each of the intervention groups)
Participant exclusion criteria
1. Do not meet all of the inclusion criteria
2. Considered by their GP to be unsuitable for the project for any reason e.g. people with severe mental impairment or severely or terminally ill
Co-morbidities, for example chronic obstructive pulmonary disease (COPD), diabetes, are not excluded from the study (unless their GP considers them unsuitable). In addition, we would not exclude entry to the trial of more than one participant per household, however, should this occur, they would be assigned to the same treatment group (to minimise the potential for contamination).
Recruitment start date
01/04/2009
Recruitment end date
31/01/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
General Practice & Primary Care Research Unit
Cambridge
CB2 0SR
United Kingdom
Sponsor information
Organisation
University of Cambridge (UK)
Sponsor details
Research Services Division
16 Mill Lane
Cambridge
CB2 1SB
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK) - School for Primary Care Research (SPCR) (ref: 4.29)
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
2013 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23575031
Publication citations
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Protocol
Sutton S, Smith S, Jamison J, Boase S, Mason D, Prevost AT, Brimicombe J, Sloan M, Gilbert H, Naughton F, Study protocol for iQuit in Practice: a randomised controlled trial to assess the feasibility, acceptability and effectiveness of tailored web- and text-based facilitation of smoking cessation in primary care., BMC Public Health, 2013, 13, 324, doi: 10.1186/1471-2458-13-324.