Condition category
Mental and Behavioural Disorders
Date applied
23/12/2008
Date assigned
02/03/2009
Last edited
07/05/2013
Prospective/Retrospective
Prospectively 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

Prof Stephen Sutton

ORCID ID

Contact details

General Practice & Primary Care Research Unit
Department of Public Health & Primary Care
University of Cambridge
Institute of Public Health
Forvie Site
Robinson Way
Cambridge
CB2 0SR
United Kingdom

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 smoker’s 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

http://www.rsd.cam.ac.uk/

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

  1. 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.

Additional files

Editorial Notes