TXT2STOP: A randomised controlled trial of a novel smoking cessation intervention using mobile phone text-messaging

Lead Research Organisation: London Sch of Hygiene and Trop Medicine
Department Name: Epidemiology and Population Health

Abstract

We aim to test the effects of mobile phone based smoking cessation support on self reported smoking status verified using a biochemical test on a sample of saliva at six months. Smoking contributes to the death of one in two of those who continue to smoke past 35 years of age.
Mobile phones allow personalised smoking cessation support programmes to be delivered inexpensively wherever the person is located. The New Zealand STOMP (stop smoking with mobile phones) trial found a doubling in quit rates at six weeks but provided no reliable data on long term effects.
The Txt2stop intervention is based on the STOMP programme, modified for use in the UK. To modify the intervention, youth smoking cessation counsellors and 62 potential participants reviewed all text messages in a series of focus groups. We have already conducted a pilot study among 200 participants. We achieved 93% long term follow up. The short term results show a doubling of quit rate (24% vs. 10%).
The Txt2stop trial among 5800 participants will establish the impact of mobile phone based smoking cessation support.

Technical Summary

Background: Most of those killed by tobacco started smoking as teenagers and smoking kills one in two of those who continue to smoke past 35 years of age. Over half of young smokers want to quit or cut down but there is no evidence of the long term efficacy of smoking-cessation interventions in young people. Mobile phones provide a new channel for individualised programmes to be delivered inexpensively wherever the person is located and are popular with young people. The STOMP (stop smoking with mobile phones) trial assessed the effectiveness of a text message-based smoking cessation intervention in New Zealand. The results show considerable promise, with a two-fold increase in reported quit rates at 6 weeks. However, limitations in this study compromised the validity of the results at 6 months.
Drawing on the input of youth smoking cessation counsellors, cognitive behavioural therapists, motivational interviewing trained smoking cessation counsellors and 62 potential participants who reviewed all text messages in a series of focus groups, we modified the STOMP intervention for the UK. A pilot RCT which addressed the limitations of the previous study has been conducted with 200 participants. We recruited the target of 200 participants within two weeks from the trial launch. We achieved 98% complete short term follow up. The early results show a doubling of quit rate (24% vs. 10%). The long term outcome response rate is currently 93% with data collection still ongoing. The Txt2stop trial is needed to provide robust information on the long-term effectiveness of text messaging smoking cessation support.

Aim: To reliably assess whether a package of mobile phone based support can improve smoking cessation rates at 6 months.

Methods: We will conduct a single-blind randomised controlled trial of the Txt2stop mobile phone based smoking cessation intervention. 5,400 participants aged 16 and over will be randomised to the intervention or control group by computer. The primary outcome is self-reported abstinence at 6 months, verified by salivary cotinine testing. All analyses will be based on the intention-to-treat principle. The difference between the proportions that have quit at different stages of follow-up will be assessed using the chi-square statistic, with estimation of relative risks, 95% confidence intervals and two-sided p-values.

Implications: If successful, the study will provide robust evidence of the long term effectiveness of a smoking cessation intervention delivered by mobile phone. This will have major public health implications for tobacco related mortality and morbidity.

Publications

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Free CJ (2011) Do messages of scarcity increase trial recruitment? in Contemporary clinical trials

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Devries KM (2013) Preventing smoking relapse using text messages: analysis of data from the txt2stop trial. in Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco

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Douglas N (2013) 'Someone batting in my corner': experiences of smoking-cessation support via text message. in The British journal of general practice : the journal of the Royal College of General Practitioners

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Guerriero C (2013) The cost-effectiveness of smoking cessation support delivered by mobile phone text messaging: Txt2stop. in The European journal of health economics : HEPAC : health economics in prevention and care

 
Guideline Title Is a new service not a guideline but no option for this
Description DH England text service for smoking cessation
Geographic Reach National 
Policy Influence Type Citation in clinical guidelines
Impact Over 47,000 people have joined the new smoking cessation support service delivered by text message. I advised the DH on the content of the new service based on my experience from the txt2stop trial. The service evaluation shows that a similar or higher proportion of smokers in the service were quit compared to smokers in the txt2stop trial intervention group. If these 47,000 people have the same benefits as smokers in the trial and based on the trial cost effectiveness analysis the smokers recruited to date will benefit from over 790 life years saved, 1,270 QALY gained. No further data has been available from the DH England regarding service use beyond 2013, although the service is still available.
 
Description WHO initiative for M-health for tobacco control
Geographic Reach Multiple continents/international 
Policy Influence Type Participation in a advisory committee
Impact WHO used the txt2stop campaign in a presentation and panel discussion for member states focused on mHealth (health-related messages delivered by mobile phone) in Geneva in May 2013. The event was hosted by Costa Rica, which in April 2013 had become the first to roll out its own equivalent of the txt2stop campaign. At least 175 delegates from WHO member states, civil society, private sector representatives and the media attended. WHO invited Free to be a member of the WHO informal working group on m-cessation in recognition of her 'leadership and experience in m-cessation'. India launched its smoking cessation support delivered by text message service nationally in Jan 2015. Over 170,000 people joined the service in the first 10 days of its launch. The Phillipines and Tunisia are implementing national programmes with WHO during 2016. Ongoing monitoring of these programmes is planned.
 
Description text message smoking cessation support service made available in England, USA
Geographic Reach Multiple continents/international 
Policy Influence Type Influenced training of practitioners or researchers
Impact A service was implmented in England and is ongoing. By Following the publication of the paper in The Lancet in 2011, the Tobacco Control Marketing Team for the Department of Health (DH) in England approached Free to help them develop a new text messaging service. Free advised the DH regarding the text message content for the intervention and provided extensive feedback on the messages written. She also gave advice regarding the design of the intervention covering the delivery system requirements, message frequency and the interactive features required. The service was made available free at the point of delivery from the NHS Stop Smoking website in January 2012. By the end of March 2013, over 34,000 smokers had joined the programme. The services is still available via the NHS smokefree website. As the intervention is highly cost effective and more cost effective than other smoking cessation treatments this will have increased the efficiency and effectivness of service delivery. In the USA, Agile Health - a commercial provider of mobile health care engagement solutions - based their Kick Buts programme, launched in 2012, on the LSHTM and STOMP trials.5.9 A technologically improved version, Kick Buts 2.0, offering Facebook integration and a Spanish language version among other things, was launched in January 2013. By the middle of 2013, 1,000 people had signed up to Kick Buts.
 
Title Interventions to increase trial recruitment 
Description Intervention delivered by mobile phone to increase trial recruitment 
Type Of Material Improvements to research infrastructure 
Provided To Others? No  
Impact Increased recruitment to our trial. A paper disseminating the results 
 
Title Multiple Imputation by Chained Equations 
Description A research paper exploring predictors of quitting and loss to follow up in our data set and discussing the implications for the most appropriate analysis for the trial results (MICE, complete case or extreme case analysis where all those lost to follow up are treated as smokers) 
Type Of Material Data analysis technique 
Provided To Others? No  
Impact A research paper is in preparation. This will contribute to the debate regarding the most appropriate form of analysis in smoking cessation trials. 
 
Title The application of marketing models to trials recruitment 
Description A research paper outlining how marketting models were applied to recruitement in the txt2stop trial 
Type Of Material Improvements to research infrastructure 
Provided To Others? No  
Impact Two papers have been submitted for publication in a peer reviewed journal based on this work 
 
Title predictors of the validity of self reported smoking cessation 
Description We explored demographic and data collection methods as predicitors of the validty of self reported smoking status and cessation. this work infomra our understanding of the validity of self reported smoking cessation 
Type Of Material Physiological assessment or outcome measure 
Provided To Others? No  
Impact A paper is in preparation for a peer reviewed journal which will put the outcomes in the public domain 
 
Description Adviser to the WHO m technologies for tobacco control group 
Organisation World Health Organization (WHO)
Department Tobacco Free Initiative (TFI)
Country Switzerland, Swiss Confederation 
Sector Public 
PI Contribution I am an advisor to the M health initiative for tobacco control. Advising on intervention content for smoking cessation programmes delivered by text message for WHO.
Collaborator Contribution WHO are working with Cost rica in implementing a smoking cessation programme delivered by text message. In 2016 India Launched its national version of smokingc cessation support delivered by text messages and the Phillipines and Tunisia are due to launch their versions of the intervention in 2017. Many other countries have expressed an interest in the initiative.
Impact The service has been launched in Costa rica in 2013 and in India in 2016. We are awaiting the outcome of the evaluation.
Start Year 2012
 
Description Communications for trial recruitment 
Organisation QUIT (Smoking Cessation Charity)
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Charity/Non Profit 
PI Contribution We evaluated the impact of communications and adverts and used this to develope the ongoing communications strategy regarding the trial
Collaborator Contribution The QUIT communications team designed and delivered the initial communications strategy to promote the txt2stop trial.
Impact The trial fully recruited on time
Start Year 2007
 
Description DOH for implementing a text messaging stop smoking intervention for the NHS 
Organisation Department of Health (DH)
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Public 
PI Contribution I have advised the DOH regarding the content, delivery, and promotion of their smoking cessation support delivered by text message. This will be available in England with the New Year stop smoking campaign 2012
Collaborator Contribution implementation of text messaging smoking cessation support into the stop smoking services available on the NHS.
Impact the NHS text message support program for smoking cessation
Start Year 2011
 
Description Developing the intervention 
Organisation QUIT (Smoking Cessation Charity)
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Charity/Non Profit 
PI Contribution We interviewed smoking cessation counsellors regarding the ways they support smokers and used the material generated from interviews to develope text messages for smokers. We tested all text messages that we generated and that were in the original STOMP program with smokers in focus groups. We modifying or discarding messages until smokers reported they were acceptable and understandable.
Collaborator Contribution We collaborated with smoking cessation counsellors to modify the intervention for the UK and to improve the interventionThe Clinical Trials Research Unit developed the STOMP mobile phone based smoking cessation intervention. This intervention was modified and further developed for the UK population resulting in the txt2stop intervention
Impact The txt2stop intervention as evaluated in the txt2stop pilor trial The additions and modifications to the txt2stop intervention following the txt2stop pilot trial
Start Year 2006
 
Description Developing the intervention 
Organisation University of Auckland
Department Clinical Trials Research Unit
Country New Zealand 
Sector Academic/University 
PI Contribution We interviewed smoking cessation counsellors regarding the ways they support smokers and used the material generated from interviews to develope text messages for smokers. We tested all text messages that we generated and that were in the original STOMP program with smokers in focus groups. We modifying or discarding messages until smokers reported they were acceptable and understandable.
Collaborator Contribution We collaborated with smoking cessation counsellors to modify the intervention for the UK and to improve the interventionThe Clinical Trials Research Unit developed the STOMP mobile phone based smoking cessation intervention. This intervention was modified and further developed for the UK population resulting in the txt2stop intervention
Impact The txt2stop intervention as evaluated in the txt2stop pilor trial The additions and modifications to the txt2stop intervention following the txt2stop pilot trial
Start Year 2006
 
Description The IT to deliver the intervention 
Organisation University of Auckland
Department Clinical Trials Research Unit
Country New Zealand 
Sector Academic/University 
PI Contribution We modified the system specifications to improve the IT delivering the intervention and added in specific new features
Collaborator Contribution The CTRU developed the original IT to deliver the txt2stop intervention . We used this IT in the trial
Impact The IT and accompanying system specifications to deliver the txt2stop intervention
Start Year 2007
 
Title txt2stop mobile phone text messaging intervention for smoking cessation 
Description All text messages developed for the txt2stop intervention are copyright of the LSHTM 
IP Reference  
Protection Copyrighted (e.g. software)
Year Protection Granted 2007
Licensed No
Impact Intervention due to be rolled out in the nhs january 2012
 
Title txt2stop smoking cessation support intervention 
Description The txt2stop intervention was developed from the University of Auckland STOMP intervention. Cancer Research UK funded the modification and development of the intervention for the UK. The MRc funded the main trial evaluating the intervention 
Type Preventative Intervention - Behavioural risk modification
Current Stage Of Development Late clinical evaluation
Year Development Stage Completed 2010
Development Status Under active development/distribution
Clinical Trial? Yes
Impact The intervention was made available through the NHS smoking cessation services in England in 2012. 
 
Description dissemination in the media, radio, newspaper, magazines, TV 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Primary Audience Media (as a channel to the public)
Results and Impact Media coverage following the txt2stop trial publication(2011) included numerous radio interviews, coverage by Associated Press Television News and interviews for articles.
Here are some of the highlights:-
BBC News: http://www.bbc.co.uk/news/health-13956252
BBC Radio 4 Today: Dr Caroline Free discusses the study in a live interview: http://news.bbc.co.uk/today/hi/today/newsid_9526000/9526686.stm
Daily Mail: http://www.dailymail.co.uk/health/article-2009734/Quit-smoking-Text-service-doubles-chances-giving-cigarettes.html
News from the Network. National Institute for Health Research 2011
Reuters: http://uk.reuters.com/article/2011/06/30/uk-smoking-texts-idUKTRE75T00H20110630
AFP: http://www.google.com/hostednews/afp/article/ALeqM5gwZSbOK6i-fsomzx9tiF9WG46I-Q?docId=CNG.4dbc45ab115b224b1b078e5f257a90e1.341
Bloomberg: http://www.bloomberg.com/news/2011-06-29/-quit-day-text-messages-help-smokers-kick-habit-research-shows.html
Guardian (Press Association): http://www.guardian.co.uk/healthcare-network/2011/jun/30/motivational-text-messages-help-smokers-quit
USA Today: http://yourlife.usatoday.com/health/story/2011/06/Study-Texting-may-help-smokers-quit-faster/48988698/1
Boots Wed MD: http://www.webmd.boots.com/smoking-cessation/news/20110629/quit-smoking-with-text-help
Yahoo News (AFP): http://uk.news.yahoo.com/nevr-2-l8-text-messages-double-chance-quitting-220332703.html
MSN Health & Fitness: http://health.msn.com/health-topics/quit-smoking/motivational-text-messages-may-help-smokers-quit
Extensive local coverage including:
Bradford Telegraph & Argus: http://www.thetelegraphandargus.co.uk/news/local/localbrad/9112674.Text_messages_help_smokers_to_quit/
Belfast Telegraph: http://www.belfasttelegraph.co.uk/news/local-national/uk/text-messages-help-smokers-quit-16017719.html
Shropshire Star: http://www.shropshirestar.com/uk/uk-news/2011/06/30/text-messages-help-smokers-quit/
Radio interviews for: Sky News Radio (for 300+ UK commercial radio stations), BBC London, BBC Sheffield, BBC Three Counties Radio
Other international and online coverage includes:
Television: Bangladesh: ATN Bangla, Impress TV, Banglavision. Brunei RTB, Hong Kong PCCW, India: B.A.G. film, Raj TV, ETV, NDTV. Indonesia: Bali TV, Global TV, Malaysia: Astro TV, Pakistan: GEO, Taiwan: Tzu Chi, SETTV. Thailand: TV Ch3, True visions plc, Vietnam: Ho Chi Minh TV, Agricultural TV channel
Times of India: http://timesofindia.indiatimes.com/life-style/health-fitness/health/Txt2stop-helps-smokers-to-quit-smoking-faster/articleshow/9048874.cms
CBC News Canada: http://www.cbc.ca/news/health/story/2011/06/29/smoking-quit-text-messages.html
CBS News: http://www.cbsnews.com/8301-504763_162-20075793-10391704.html
Irish Examiner: http://www.irishexaminer.com/ireland/text-message-service-helps-smokers-kick-habit-159465.html
Science Daily (US): http://www.sciencedaily.com/releases/2011/06/110629203027.htm
Top News US: http://topnews.us/content/241492-txt2stop-helps-smokers-quit-habit
http://www.andhranews.net/Health/2011/Txt2stop-helping-smokers-quit-smoking-faster-776.htm
The Australian: http://www.theaustralian.com.au/news/world/texts-messages-helping-smokers-quit/story-e6frg6so-1226084704852
Medical Observer Australia: http://www.medicalobserver.com.au/news/text-messages-may-improve-smoking-cessation
Emirates 24/7: http://www.emirates247.com/news/text-messages-help-smokers-quit-2011-06-30-1.405256
The China Post: http://www.chinapost.com.tw/life/science-&-technology/2011/07/01/308158/Study-finds.htm
Fox 31 Denver: http://www.kdvr.com/lifestyle/sns-rt-us-smoking-textstre75t00q-20110630,0,320810.story
Cancer Research UK: http://info.cancerresearchuk.org/news/archive/cancernews/2011-06-29-Study-shows-benefits-of-motivational-text-messages-for-smoking-cessation-?rss=true
NHS Choices: http://www.nhs.uk/news/2011/06June/Pages/text-message-smoking-cessation-research.aspx
http://www.news-medical.net/news/20110630/Mobile-phone-text-messages-help-smokers-to-beat-addiction.aspx
http://www.firstscience.com/home/news/breaking-news-all-topics/text-message-support-for-smokers-doubles-quit-rates_108615.html


There was considerable interest in the txt2stop trial results from the media worldwide.
Year(s) Of Engagement Activity 2011
 
Description implementing the intervention to make it available to the UK public 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Primary Audience Public/other audiences
Results and Impact A text messaging smoking cessation support program will be available to the public in England
Year(s) Of Engagement Activity 2011