A randomised controlled trial of mobile phone based smoking cessation support Free C, Knight R, Robertson S, Roberts I, Rodgers A, Whittaker R, Cairns J. LSHTM CTRU Auckland QUIT

A randomised controlled trial of mobile phone based smoking cessation support

Free C, Knight R, Robertson S, Roberts I, Rodgers A, Whittaker R, Cairns J.

LSHTM

CTRU Auckland

QUIT

Distinct capabilities and advantages of mobile phones as communication channel for health Versatility and accessibility offer huge potential High penetration Part of every day life so always carried with them (so intervention can take place any time) Interactive Personalised ‘ Push’ and ‘pull’ content Delivery of complex information can be facilitated through the use of video, graphic and audio systems Anonymity and confidentiality Main costs associated with development, ongoing costs relatively low

Distinct capabilities and advantages of mobile phones as communication channel for health

Versatility and accessibility offer huge potential

High penetration

Part of every day life so always carried with them (so intervention can take place any time)

Interactive

Personalised

‘ Push’ and ‘pull’ content

Delivery of complex information can be facilitated through the use of video, graphic and audio systems

Anonymity and confidentiality

Main costs associated with development, ongoing costs relatively low

BACKGROUND Smoking contributes to the death of one in two of those who continue to smoke past 35 years of age Mobile phones provide a new channel for individualised programmes to be delivered inexpensively wherever the person is located

BACKGROUND

Smoking contributes to the death of one in two of those who continue to smoke past 35 years of age

Mobile phones provide a new channel for individualised programmes to be delivered inexpensively wherever the person is located

txt2stop is an innovative smoking cessation support programme Originally developed in Auckland, NZ STOMP randomised trial, 1705 participants from throughout New Zealand Found a doubling of self reported quit rates at 6 weeks Questions re the validity of findings at six months - high rate of loss to follow up - small proportion biochemically validated

txt2stop is an innovative smoking cessation support programme

Originally developed in Auckland, NZ

STOMP randomised trial, 1705 participants from throughout New Zealand

Found a doubling of self reported quit rates at 6 weeks

Questions re the validity of findings at six months

- high rate of loss to follow up

- small proportion biochemically validated

MODIFICATIONS FOR THE UK Expert input: trained smoking cessation counsellors (youth and adult) and cognitive experts User input: 62 potential participants in series of focus groups (smokers) Four types of modification were made: changes to words changes to culturally specific references changes to the framing of text messages changes or removal of some texts strengthening content

MODIFICATIONS FOR THE UK

Expert input: trained smoking cessation counsellors (youth and adult) and cognitive experts

User input: 62 potential participants in series of focus groups (smokers)

Four types of modification were made:

changes to words

changes to culturally specific references

changes to the framing of text messages

changes or removal of some texts

strengthening content

THE INTERVENTION Regular personalised text messages developed drawing on theories of behaviour change and MI providing smoking cessation information, motivation, distraction, social support Algorithm matched participant characteristics with database of over 1000 text messages Matched on interests and concerns over quitting (i.e. weight gain)

THE INTERVENTION

Regular personalised text messages developed drawing on theories of behaviour change and MI

providing smoking cessation information, motivation, distraction, social support

Algorithm matched participant characteristics with database of over 1000 text messages

Matched on interests and concerns over quitting (i.e. weight gain)

THE INTERVENTION: Making a public declaration - state a quit date Self monitoring e.g. review their smoking habits/ triggers. Intra-treatment support- ‘buddying’ facility, Extra treatment support - texting friends and family. Problem solving – e.g. by asking participants to consider and plan alternate actions to smoking. Feedback (timing) Distraction techniques – text crave, Encourage use NRT. CBT/ MI approach e.g. participants own values and goals e.g. reasons for quitting beliefs about ability to achieve their goal to quit - encouraging participants to break their goal into achievable steps. Tailored - e.g. peer pressure or weight gain

THE INTERVENTION:

Making a public declaration - state a quit date

Self monitoring e.g. review their smoking habits/ triggers.

Intra-treatment support- ‘buddying’ facility,

Extra treatment support - texting friends and family.

Problem solving – e.g. by asking participants to consider and plan alternate actions to smoking.

Feedback (timing)

Distraction techniques – text crave,

Encourage use NRT.

CBT/ MI approach e.g.

participants own values and goals e.g. reasons for quitting

beliefs about ability to achieve their goal to quit - encouraging participants to break their goal into achievable steps.

Tailored - e.g. peer pressure or weight gain

PILOT TRIAL Performed May to November 2006 200 participants Interested participants were asked to text in their interest to a specified number Eligibility criteria: Report aged 16 or over Smoker who owned a mobile phone Expressed an interest in wishing to quit in next month Further information then sent via email/mail Interested participants to text back their consent Baseline data collected by telephone

PILOT TRIAL

Performed May to November 2006

200 participants

Interested participants were asked to text in their interest to a specified number

Eligibility criteria:

Report aged 16 or over

Smoker who owned a mobile phone

Expressed an interest in wishing to quit in next month

Further information then sent via email/mail

Interested participants to text back their consent

Baseline data collected by telephone

RANDOMISATION computer based randomisation into intervention or control group Intervention – participants were asked to set a ‘quit date’. 5 Personalised texts messages were sent to their mobile phones on a daily basis from that date Included was a ‘CRAVE’ option and a ‘Quit buddy’ Control – received fortnightly text messages

RANDOMISATION

computer based randomisation into intervention or control group

Intervention – participants were asked to set a ‘quit date’. 5 Personalised texts messages were sent to their mobile phones on a daily basis from that date

Included was a ‘CRAVE’ option and a ‘Quit buddy’

Control – received fortnightly text messages

Results RESULTS Technical side effective. Follow up at 4 weeks and 6 months Outcome measures: Primary – self reported abstinence (6 mths) Verified by salivary cotinine testing (postal and witnessed) Secondary – 4 weeks smoking status. 6 month involvement in car crashes

RESULTS

Technical side effective.

Follow up at 4 weeks and 6 months

Outcome measures:

Primary – self reported abstinence (6 mths) Verified by salivary cotinine testing (postal and witnessed)

Secondary – 4 weeks smoking status. 6 month involvement in car crashes

RESULTS Doubling of quit rate in short term Relative risk 2.02 (95%CI 1.08-3.76) Long term results consistent with results we are looking for in main trial (relative risk 1.28)

RESULTS

Doubling of quit rate in short term

Relative risk 2.02 (95%CI 1.08-3.76)

Long term results consistent with results we are looking for in main trial (relative risk 1.28)

MAIN STUDY Trial launched 15 th October 2007 5,800 people in the UK recruited in less than 21 months Funding from MRC

MAIN STUDY

Trial launched 15 th October 2007

5,800 people in the UK recruited in less than 21 months

Funding from MRC

CHANGES MADE FOR MAIN TRIAL Strengthened relapse components (LAPSE function) and increased interactivity Plain English version was developed Increased personalisation: Optional text messages about how tobacco companies promote smoking Improved data collection methods

CHANGES MADE FOR MAIN TRIAL

Strengthened relapse components (LAPSE function) and increased interactivity

Plain English version was developed

Increased personalisation:

Optional text messages about how tobacco companies promote smoking

Improved data collection methods

Demographics of main trial Registered 10,627 eligible participants of those 55% were randomised SEX n % Female 2606 45% Male 3194 55% Age (16-18) 194 3% (19-34) 2396 41% (>34) 3210 56% Education To age 16 or less 2538 44% > age 16 3262 56% Fagerstrom 5 or less 3488 60% >5 2312 40%

Results due spring 2010 Implications, if effective: For smoking cessation: Huge potential for delivery globally, especially relevant where smoking cessation service infrastructure lacking e.g. China, India For health and health care behaviour (combined with systematic review)

Results due spring 2010

Implications, if effective:

For smoking cessation:

Huge potential for delivery globally, especially relevant where smoking cessation service infrastructure lacking e.g. China, India

For health and health care behaviour (combined with systematic review)