iQuit in practice: a study to examine a personalised web-and text message programme to support smoking cessation in Primary Care
| ISRCTN | ISRCTN56702353 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56702353 |
| Secondary identifying numbers | N/A |
- Submission date
- 23/12/2008
- Registration date
- 02/03/2009
- Last edited
- 25/09/2018
- 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
Prof Stephen Sutton
Scientific
Scientific
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
Study information
| Study design | Two parallel group randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/04/2009 |
| Completion date | 31/01/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | Total approx 600 (300 in each of the intervention groups) |
| Key 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 |
| Key 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). |
| Date of first enrolment | 01/04/2009 |
| Date of final enrolment | 31/01/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
General Practice & Primary Care Research Unit
Cambridge
CB2 0SR
United Kingdom
CB2 0SR
United Kingdom
Sponsor information
University of Cambridge (UK)
University/education
University/education
Research Services Division
16 Mill Lane
Cambridge
CB2 1SB
England
United Kingdom
| Website | http://www.rsd.cam.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/013meh722 |
Funders
Funder type
Government
National Institute for Health Research (NIHR) (UK) - School for Primary Care Research (SPCR) (ref: 4.29)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 10/04/2013 | Yes | No | |
| Results article | results | 01/07/2014 | Yes | No |
Editorial Notes
25/09/2018: Publication reference added.
