Plain English Summary
Trial website
Contact information
Type
Public
Primary contact
Ms Joanna Mitchell
ORCID ID
http://orcid.org/0000-0003-2138-3402
Contact details
Department of Public Health and Primary Care
Institute of Public Health
Forvie Site
University of Cambridge School of Clinical Medicine
Box 113
Cambridge Biomedical Campus
Cambridge
CB2 0SR
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
30934
Study information
Scientific title
Improving quit rates among smokers in primary care: Pragmatic trial of effectiveness and cost-effectiveness of a tailored web- and text message-based intervention for smoking cessation (iQuit in Practice)
Acronym
Study hypothesis
The aim of this study is to establish the effectiveness and cost-effectiveness of the iQuit in Practice intervention compared to routine care alone.
This study is a follow up study to a pilot study available via: http://www.isrctn.com/ISRCTN56702353
Ethics approval
East of England - Cambridge East Research Ethics Committee, 29/02/2016, ref: 16/EE/0030
Study design
Randomised; Interventional; Design type: Treatment, Psychological & Behavioural
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Community
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Specialty: Primary Care, Primary sub-specialty: Public Health; UKCRC code/ Disease: Cancer/ Malignant neoplasms of respiratory and intrathoracic organs, Cardiovascular/ Pulmonary heart disease and diseases of pulmonary circulation, Respiratory/ Lung diseases due to external agents, Stroke/ Cerebrovascular diseases
Intervention
Patients will be randomly allocated to either the control or intervention group during the consultation through the on-line iQuit software.
Control group: Participants receive usual care alone. This involves having a face to face discussion on reasons why a patient smokes and why they may want to quit; a breath test to measure CO and a discussion on stop smoking treatments that are available such as nicotine replacement therapies and Champix. Patients are also offered follow-up support and advice on how to avoid potential pitfalls that might get in the way of a successful quit attempt.
Intervention group: Participants receive the iQuit intervention. In addition to ‘usual care’ and the tailored report generated from the iQuit software, participants will begin to receive text messages the day before their quit date and 0, 1 or 2 messages each day for 90 days. The following are examples of text messages a participant might receive.
“Hi Sarah, welcome to iQuit in Practice, a personal program of quitting support. We hope you enjoy it and that it helps in your quit attempt. The iQuit team.”
“As well as removing cigarettes and ashtrays, ask any visitors not to smoke inside. Now's a great time to freshen up the curtains and wipe away any smoke stains.”
“Quitting is great for your skin. Several studies have found measureable improvements in the skin tone of quitters, often within in the first four weeks!”
“By staying quit, your immune system will start to recover, meaning you'll soon be better able to fight off colds and other illnesses.”
“After all your effort to get this far, make sure you reward yourself. It's a real achievement, and this time it's for good. :-)”
“Don't believe 'just one' is okay: A 2010 review found that even 'light' smokers were at much more risk of lung problems and cataracts compared to non-smokers.”
“Hi Sarah, great job so far. Just make sure you don't give yourself any excuses. You decided to quit because you wanted to QUIT.”
Follow up is at 4 weeks and 6 months post quit date: Follow-up is a CO test (at 4 weeks), a questionnaire and saliva test (at 6 months).
Intervention type
Other
Phase
Drug names
Primary outcome measures
Self-reported abstinence from smoking for 6 months endorsed by biochemical verification measured 6 months after the participant’s quit date. Abstinence from smoking will be measured 6 months after the participant’s quit date using a questionnaire (sent by the research team) followed by biochemical verification. All participants that have stated in the questionnaire they have not smoked for 6 months will be sent a kit to collect a saliva sample. The sample will be analysed for cotinine (a nicotine metabolite). If the sample is positive for cotinine then the sample will also be assayed for anabasine to differentiate whether the cotinine has come from tobacco, E-Cig or NRT.
Secondary outcome measures
1. Abstinence is measured using carbon monoxide (CO) testing at baseline and the routine follow-up 4-week appointment in the patient’s GP practice
2. Abstinence is measured through self-reporting using a questionnaire deigned for this study at 6 months (not biochemically validated)
3. Cost-effectiveness of the intervention is determined using a questionnaire at 6 months post quit date will determine NHS costs accumulated during the previous 6 months through questions on GP visits and medications prescribed, including NRTs
Overall trial start date
11/07/2016
Overall trial end date
31/12/2018
Reason abandoned
Eligibility
Participant inclusion criteria
1. Current smoker aged 16 - 75
2. Wants to quit and willing to attending for smoking cessation support at a GP practice
3. Owns a mobile phone and familiar with sending/receiving text messages
4. Able to read and understand English, and give informed written consent
5. Willing to set a quit-date within 14 days of starting the study
6. Not currently involved in another formal smoking cessation study
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 1452; UK Sample Size: 1452
Participant exclusion criteria
1. Not meeting the inclusion criteria
2. Their GP feels that it would not be appropriate for them to participate (e.g. severe complex additional health problems)
Recruitment start date
11/07/2016
Recruitment end date
31/12/2018
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Alconbury and Brampton Surgery
School Lane
Alconbury
Huntingdon
PE28 4EQ
United Kingdom
Trial participating centre
Cathedral Medical Centre
Princess of Wales Hospital
Kilkenny Avenue
Lynn Road
Ely
CB6 1DN
United Kingdom
Trial participating centre
The Riverside Practice
23 Marylebone Road
March
PE15 8BG
United Kingdom
Trial participating centre
Prospect Medical Practice
95 Aylsham Road
Norwich
NR3 2HW
United Kingdom
Trial participating centre
Hanscombe House Surgery
52A St Andrew Street
Herford
SG14 1JA
United Kingdom
Trial participating centre
The Cornerstone Practice
Elwyn Road
March
PE15 9BF
United Kingdom
Trial participating centre
The Old Exchange
East Street
St. Ives
PE27 5PB
United Kingdom
Trial participating centre
Sawston Medical Centre
London Road
Sawston
CB22 3HU
United Kingdom
Trial participating centre
The Peninsula Practice
Mill Hoo
Alderton
IP12 3DA
Trial participating centre
Mundesley Medical Centre
Munhaven Close
Mundesley
Norwich
NR11 8AR
United Kingdom
Trial participating centre
Beccles Medical Centre
St. Mary's Road
Beccles
NR34 9NX
United Kingdom
Trial participating centre
Fakenham Medical Practice
Meditrina House
Trinity Road
Fakenham
NR21 8SY
United Kingdom
Trial participating centre
Wellside Surgery
45 High Street
Sawtry
Huntingdon
PE28 5SU
United Kingdom
Trial participating centre
Welland Medical Practice
142 Eye Road
Peterborough
PE1 4SG
United Kingdom
Trial participating centre
Feltwell Surgery
Old Brandon Road
Feltwell
IP26 4AY
United Kingdom
Trial participating centre
Oak Street Medical Practice
Oak Street
Norwich
NR3 3DL
United Kingdom
Trial participating centre
Hingham Surgery
Hardingham Street
Hingham
NR9 4JB
United Kingdom
Trial participating centre
The Maples Health Centre
Vancouver Road
Broxbourne
EN10 6FD
United Kingdom
Trial participating centre
The Chesterfield Drive Practice
29 Chesterfield Drive
Ipswich
IP1 6DW
United Kingdom
Trial participating centre
Grove Surgery
Grove lane
Thetford
IP24 2HY
United Kingdom
Trial participating centre
Hoveton and Wroxham Medical Practice
Stalham Road
Hoveton
NR12 8DU
United Kingdom
Trial participating centre
Kirkley Mill Surgery/Falkland Surgery
Clifton Road
Lowestoft
NR33 0HF
United Kingdom
Trial participating centre
Leighton Road Surgery
1 Leighton Road
Leighton Buzzard
LU7 1LB
United Kingdom
Trial participating centre
Flitwick Surgery
Highlands
Flitwick
MK45 1DZ
United Kingdom
Trial participating centre
Greensands Surgery
The Health Centre
Oliver Street
Ampthilll
MK45 2SB
United Kingdom
Trial participating centre
Pemberley Surgery
32 Pemberley Avenue
Bedford
MK40 2LA
United Kingdom
Funders
Funder type
Charity
Funder name
Cancer Research UK
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
The main papers to come out from this trial will be the protocol paper and trial results. Recruitment and follow-up is expected to be complete by the autumn of 2019 with trial publications being published in early 2020. At around this time it is expected that findings will also be presented at academic conferences and GP research forums.
Intention to publish date
31/03/2020
Participant level data
Available on request
Results - basic reporting
Publication summary