Tobacco Use Clinical Trial
Official title:
Measuring for Change: Air Quality Feedback to Reduce Second-hand Smoke (SHS) Exposure in the Home
This is a European study which is part of a larger research project (The TackSHS project)
funded by the European Union's Horizon 2020 Research and Innovation Programme (Grant
Agreement No 681040) and led by the Catalan Institute of Oncology.
This study will examine the efficacy of using personalised air quality measurements in homes
of smokers to encourage behaviour-change towards having a smoke-free home environment.
Building on recent quantitative and qualitative work showing that feedback of second-hand
smoke (SHS) measurement information can help motivate smokers to change their behaviour. This
study will develop a targeted intervention for use with socio-economically deprived smokers
in four countries (Scotland, Spain, Greece, Italy) across the EU. Two-hundred smokers (50 in
each country) will be recruited and offered low-cost, simple to operate particle counting
instruments to measure and log SHS levels in their home for a period of 30 days. During this
time near real-time, personalised feedback will be provided to, and discussed with, the
smoker along with target-setting and exploration of suitable methods of behaviour-change.
Feedback will be given via text message to mobile phones, emails and personal voice calls. A
final visit will gather data on changes made while a proportion of participants (10-20%) in
each country will take part in a further qualitative interview by phone to gather data on
their experience of the intervention.
Study outcomes will include quantitative measures such as changes in average and maximum fine
particulate matter (PM2.5) concentrations and self-declared household smoking rules, while
qualitative data will be gathered using questionnaire and interview to explore what elements
of the intervention were useful/unhelpful, particularly well/poorly understood, and what were
the barriers for those who did not make changes. This WP will provide a comprehensive
database of baseline measurements of SHS concentrations in home settings from across the EU
with the potential to generate over 8 million minutes of measurements of household air
quality. Analysis of the differences by country and possible determinants of exposure will be
carried out.
Main Aim:
To create a smoke-free environment for children of parents who smoke, by having parents
exchange ineffective strategies to create a smoke-free environment (e.g. smoking in another
room in the house) for effective strategies (e.g. smoking outside, delaying smoking, quitting
smoking).
Sub Aim:
To test the feasibility and effectiveness of using new, internet-connected air quality
monitors to record and upload air quality information as part of an educational intervention
on the effects of smoking on household air quality.
Research Questions:
1. Can low-cost, internet-connected air quality monitors effectively detect second-hand
smoke-related PM2.5 and relay this information to researchers?
2. Can delivering this information together with advice about keeping homes smoke-free on a
daily basis over a month promote behaviour change?
3. Is providing remote feedback on air quality levels a feasible method of engaging with
parents living in areas of socio-economic deprivation?
STUDY DESIGN
This is a multi-country study using a single arm pre-test/post-test design.
STUDY SETTINGS
The study will be carried out in smokers' homes in areas of multiple deprivation in Greece,
Italy, Spain and the United Kingdom. These countries have variable rates of smoking
prevalence and a range of smoke-free places legislation, smoke-free homes policies and
therefore varying prevalence of childhood exposure to second-hand smoke.
RECRUITMENT
Participants will be recruited using targeted adverts and leaflets within public sector and
third sector environments in socio-economically deprived areas. Environments used to recruit
may include nurseries, libraries, family centres and other family directed help services
within the community. Where necessary direct advertising using traditional or social media
may also be employed. Participants will be able to express interest in taking part in the
study by contacting the research team by phone, email or text.
When a contact is made the research team will then initiate a brief telephone conversation to
address any queries and determine eligibility for inclusion in the study.
Once the potential participant is identified as suitable for inclusion and verbal consent has
been given then a Participant Information Sheet (PIS) will be sent to the participant by
email. Participants will have a minimum of 48 hours to consider the information they have
been sent, after which one of the researchers will contact them again to check whether they
are still happy to take part in the study, and if so, to arrange a suitable time for the
first home visit to install the Air Quality Monitor (AQM) to take place.
Participants will be given a £10 (or equivalent in Euros) shopping voucher for taking take
part in the study, and a further £10 if they decide to take part in the qualitative
interview. These vouchers acknowledge any minimal electricity/WiFi costs incurred as a result
of taking part in the study, and provide a means of thanking participants' for their time in
participating.
HOUSEHOLD VISITS
Informed, signed consent will be obtained at the beginning of the visit based on the
previously obtained PIS.
The AQM will be installed in the main living area of the home by the visiting researcher. The
monitor will be placed in a position that should be elevated at between 0.5-1.5m from the
floor, and at least 0.5m from a wall, window or door. The AQM will require a functioning
electrical outlet.
The AQM will be tethered to the household WiFi network. If the participant does not have
wireless broadband in their home, a pre-paid 3g/4g WiFi router will be assigned and
installed. Where a pre-paid 3g/4g WiFi router is installed this will not permit any other
devices to use the connection and will solely be for transfer of data from the AQM.
"Knowledge, Beliefs & Attitudes" module previously developed for the AFRESH programme
(http://www.smokefreehomes.network/) will be explored with the smoker and the baseline
questionnaire completed. This whole process should take approximately 45 minutes.
The AQM will then be left in situ for 30 days.
DATA SOURCES
Air quality monitoring Fine particulate matter will be monitored in each participant's home.
The Foobot (www.foobot.io) AQM will be used in this intervention. The Foobot is a low-cost
monitor containing particulate matter (PM), volatile organic compound (VOC), temperature and
humidity sensors. For the purposes of this study, the PM sensor will be used, as fine PM
(PM2.5) is an effective marker for the presence of SHS. Data such as VOC, temperature and
humidity may be utilised to help develop a predictive algorithm to help with the
differentiation of SHS from other sources of fine PM.
The Foobot's PM sensor has been tested internally in lab trials with second-hand smoke and
other air pollutants. Each participating institute will be assigned 8 Foobot instruments
providing them with the maximal capability of measuring in 8 homes per month.
Questionnaires
Each participant will be asked to complete a baseline questionnaire at the first visit from
the researcher. This questionnaire will ask about their home's inhabitants, their smoking
behaviours, smoking rules for others in the home and questions and their intention to change
smoking behaviours in the home. This will validate their inclusion in the study.
A follow-up questionnaire will gather data on changes in smoking rules in the home and views
on the intervention as an outcome measure. This questionnaire will be delivered at the end of
the 30 day intervention period.
Qualitative interviews
Between 4 and 8 participants in each country will be recruited to take part in
semi-structured interviews to discuss their experience of the intervention. A shopping
voucher of value £10 will be provided to reimburse participants for their time. The consent
form and interview topic guide for this work were adopted from AFRESH Programme (see above).
DATA MANAGEMENT
Data will be stored on Foobot company servers and downloaded each day using a custom
programme developed by University of Aberdeen researchers No identifying information on the
participants will be stored on the Foobot company servers, but researchers will have access
to personal information, including name, address, telephone number and email address.
Email and text message feedback will be sent using the custom developed programme or (where
appropriate or required) personal accounts. The Clockwork SMS API (www.clockworksms.com) will
be used to send SMS messages over the internet, while university or insitutional email
accounts will be used to send emails.
Personal information will be treated as confidential in line with relevant country and EU
data protection legislation. Consent forms and questionnaires, once collected, will be posted
(by secure mail) to the University of Aberdeen and retained in a locked filing cabinet for
seven years.
PERSONALISED FEEDBACK
At the end of the baseline measurement week the research team will initiate a series of
contacts with the participant for the following 3 weeks.
Firstly a feedback text will be sent to the participant's mobile phone providing them with
details of their average levels of PM in the previous week (day 8). An email with a link to
their detailed weekly graph will also be provided on this day. This will be followed up the
next day (day 9) with a telephone call at a pre-arranged time to discuss their results and to
talk through facilitators, barriers and solutions, and planning around 'What if…' scenarios.
From day 9 onwards daily text message results with supportive comments and suggestions will
be sent to the participant's mobile phone (days 9-29). Support phone calls providing more
detailed feedback and revisiting AFRESH modules "Barriers, solutions and facilitators to
creating a smoke-free home" and "Planning for creating a smoke-free home" will be given after
week 2 (day 16) and 3 (day 23). Weekly graphs/reports will be sent by email to the
participant the day prior to these telephone conversations (day 15 and 22).
On day 30 the researcher will visit with personalised feedback covering the whole one-month
period grouped in to the 4 previous weekly blocks. Discussion will be around progress
achieved and plans for the future.
LOCAL VARIATION
This study will be carried out in Scotland (the UK), Catalonia (Spain), Greece, and Italy.
The general protocol will be similar in all four countries with some minor changes to the
recruitment process depending on local and cultural norms. Consent forms, questionnaires, the
PIS and email and text messages will be translated into local languages as required.
POWER CALCULATION
At an individual country level the study will recruit 50 households to participate. Using
PM2.5 concentrations in the final 7 days of the 30 day measurement period as the study
primary outcome measure, and assuming that participants achieve a 50% reduction in fine
particle levels compared to the baseline measurements in days 1-7, a sample of 35 will give a
power of >80% with an alpha level of 0.05. This is based on data gathered from the First
Steps to Smoke-Free (FS2SE) project where it wasfound an average baseline PM2.5 concentration
of 67.5 µg/m3 (SD 79.7 µg/m3). Recruiting 50 subjects will thus provide sufficient numbers
assuming drop-out is <12% (broadly in line with investigators' experience in the FS2SF study
where 15 participants were lost from the 117 that completed baseline). A 50% reduction in the
mean PM2.5 value is realistic in terms of the size of change seen in other study, REFRESH,
(geometric mean fell from 19 to 11 µg/m3 at one-month). Pooled across the 4 study sites
(assuming similar exposures) a total study size of 175 homes completing the 30 day study
would provide 80% power to detect a decrease of 22% in PM2.5 concentrations.
STATISTICAL ANALYSIS
Arithmetic mean concentrations of PM2.5 will be calculated for homes over the days 1-7, days
23-29 and whole sampling time, and presented with standard deviations and ranges. All-sample
mean and median concentrations over each time period will be calculated and compared for each
country.
A first descriptive analysis will be conducted for all outcomes included in the study.
Categorical variables will be described by raw frequencies and percentages and continuous
variables will be described by means and standard deviations or medians and interquartile
range (IQR).
Medians and IQR of PM2.5 concentrations will be calculated by country and overall for the
complete intervention group. Box-plots will be used to visualize the distribution of PM2.5
concentrations. A separate secondary analysis of data by country will also be conducted.
Analysis will be conducted using Microsoft Excel 2013 and IBM SPSS v24.
ETHICS
This study will be conducted in line with the Good Clinical Practice guidelines of the
Declaration of Helsinki, along with applicable EU and local legislation.
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