Effectiveness and Cost-effectiveness of a Tailored Text Message Programme (MiQuit) for Smoking Cessation in Pregnancy

Smoking Cessation Clinical Trial

Official title:

RCT and Meta-analysis Testing Effectiveness and Cost-effectiveness of a Tailored Text Message Programme (MiQuit) for Smoking Cessation in Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03231553
• Other study ID #: 17065
• Status: Completed
• Phase: N/A
• Start date: November 30, 2017
• Est. completion date: January 15, 2020

Study information

• Verified date: April 2020
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The trial aims to determine whether or not MiQuit (text-message support programme) is effective when offered in addition to standard behavioural support for smoking cessation in pregnancy.

Description:

Smoking in pregnancy is expensive; in the UK in 2010 the annual smoking-attributable maternal and infant health care costs were estimated at up to £87.5 million. In high income countries 13% to 25% of pregnant women smoke and rates are increasing in developing ones. In the UK in 2010 26% of pregnant women smoked with highest rates seen amongst younger, socially disadvantaged women.

However, pregnancy is the life event which most motivates smoking cessation attempts and 50+% of pregnant smokers try stopping, hence smoking cessation support offered in pregnancy is likely to be especially beneficial. Regrettably, in pregnancy, there is only strong efficacy evidence for using either face-to-face or 'self-help' stop smoking support. Although nicotine replacement therapy (NRT) is widely-used by UK pregnant smokers this has at best, borderline efficacy.

Self-help support (SHS) almost doubles the likelihood of smoking cessation in late pregnancy. However SHS programmes which help pregnant smokers to quit were all developed before easily-accessible technologies became widely available.

Text message SHS smoking cessation programmes are highly-acceptable; those trialled with non-pregnant smokers in the US and UK have demonstrated efficacy. Unfortunately, neither programme is appropriate in pregnancy as they make no mention of pregnancy which for most pregnant smokers is the very reason they try quitting; consequently many pregnant smokers would likely find these programmes' advice irrelevant and ignore it.

Funded by CRUK to remedy the lack of acceptable self-help cessation support for pregnant smokers, we developed MiQuit, a text-message, smoking cessation SHS programme for pregnant smokers. MiQuit advice is relevant to pregnancy as it is highly-tailored to gestation. We evaluated MiQuit in two RCTs. The first CRUK-funded trial (n=207) demonstrated acceptability. Subsequently, with NIHR funding we refined MiQuit and tested this in a second RCT which demonstrated the feasibility of recruiting from UK National Health Service (NHS) settings to a multi-centre RCT. Again estimated efficacy was encouraging; in MiQuit and control groups, prolonged abstinence from smoking, validated in late pregnancy was 5.4% and 2.0% respectively.

To efficiently determine whether or not MiQuit works for smoking cessation, we are conducting a third RCT with an almost identical design. The efficacy of the MiQuit system will be assessed by combining the findings, using Trial Sequential Analysis methods, from this trial with the findings from the previous two MiQuit trials. Without requiring an expensive, large RCT this study will tell whether or not MiQuit is efficacious for smoking cessation in pregnancy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: January 15, 2020
• Est. primary completion date: January 15, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Pregnant and less than 25 weeks gestation

• Smoking at least 5 cigarettes per day pre-pregnancy

• Smoking at least 1 cigarette on a typical day during pregnancy

• Aged 16 or over

• Agrees to accept information to assist cessation

• Owns or has primary use of a mobile phone

• Familiar with sending and receiving text messages

• Able to understand written English (text messages are in English only) and consent issues explained in English.

• Able to give informed consent

Exclusion Criteria:

• Already enrolled in another text service to assist smoking cessation

• Already enrolled in a smoking cessation study

• Having already participated in the study in an earlier pregnancy

Related Conditions & MeSH terms

• Pregnancy Related
• Smoking Cessation

Intervention

Other:
• MiQuit text message support programme
MiQuit is an automated, responsive text message support programme lasting 12 weeks which sends texts containing self-help smoking cessation support and advice to participants mobile phones.

Locations

Country	Name	City	State
United Kingdom	University Hospitals Birmingham NHS Foundation Trust	Birmingham
United Kingdom	East Lancashire Hospitals NHS Trust	Burnley	Lancashire
United Kingdom	North Cumbria University Hospitals NHS Trust	Carlisle	Cumbria
United Kingdom	Countess of Chester Hospital NHS Foundation Trust	Chester
United Kingdom	Mid Cheshire Hospitals NHS Trust	Crewe	Cheshire
United Kingdom	University Hospitals of Derby and Burton NHS Foundation Trust	Derby	Derbyshire
United Kingdom	Birmingham Womens NHS Foundation Trust	Edgbaston	Birmingham
United Kingdom	Sherwood Forest Hospitals NHS Trust	Mansfield	Nottinghamshire
United Kingdom	Pennine Acute Hospitals NHS Trust	Multiple Locations	Greater Manchester
United Kingdom	United Lincolnshire Hospitals Trust	Multiple Locations	Lincolnshire
United Kingdom	Newcastle Upon Tyne Hospitals NHS Foundation Trust	Newcastle	Newcastle Upon Tyne
United Kingdom	Northumbria Healthcare NHS Foundation Trust	North Shields	Tyne And Wear
United Kingdom	Oxford University Hospitals NHS Foundation Trust	Oxford	Oxfordshire
United Kingdom	Plymouth Hospitals NHS Trust	Plymouth	Devon
United Kingdom	Royal Berkshire NHS Foundation Trust	Reading	Berkshire
United Kingdom	University Hospitals of North Midlands NHS Trust	Stoke-on-Trent	Staffordshire
United Kingdom	City Hospitals Sunderland NHS Foundation Trust	Sunderland

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported abstinence from smoking	Self-reported smoking abstinence from 4 weeks after enrolment until 36 weeks gestation, with no more than 5 cigarettes smoked in total between these time points, as reported and biochemically validated at 36 weeks using a cut-point used in the previous two trials.	36 weeks gestation
Secondary	Self-reported abstinence from smoking at 4 weeks after randomisation	7 day abstinence reported at 4 weeks	4 weeks after enrolment
Secondary	Abstinence from smoking at 36 weeks gestation	self-reported and biochemically validated 7 day abstinence at 36 weeks gestation	36 weeks gestation
Secondary	Use of stop-smoking services	use of stop-smoking services	36 weeks gestation
Secondary	Use of NHS care	Use of NHS care	At delivery
Secondary	Birth weight	Weight of infant at birth	At delivery
Secondary	Gestational age	Gestational age at birth	At delivery
Secondary	Fetal death	Miscarriage or stillbirth	At delivery
Secondary	Maternal death	Death of participant	At delivery
Secondary	Health Status - baseline	Health status measured by EQ-5D-5L at baseline visit	At hospital ante-natal appointment
Secondary	Health Status - 4 weeks after randomisation	Health status measured by EQ-5D-5L at 4 weeks post randomisation	4 weeks post randomisation
Secondary	Health Status - 36 weeks gestation	Health status measured by EQ-5D-5L at 36 weeks gestation	36 weeks gestation
Secondary	Maternal hospital admissions	Hospital admission of participant	At delivery
Secondary	Infant hospital admission	Hospital admission of infant	At delivery
Secondary	Staff costs	Overheads and other consumables required to deliver the MiQuit intervention and usual care	Upto 40 weeks after enrolment