Tobacco Use Clinical Trial
— TackSHSWP4Official title:
Measuring for Change: Air Quality Feedback to Reduce Second-hand Smoke (SHS) Exposure in the Home
Verified date | August 2019 |
Source | Institut Català d'Oncologia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 86 |
Est. completion date | May 1, 2019 |
Est. primary completion date | May 1, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Adult (18 years or over) who smokes inside their home on a daily basis 2. Takes care of a child (16 years old or under) in their home at least once per week 3. Lives in a SIMD quintile 1 or 2 postcode or equivalent (i.e. within 40% most deprived households in their country) 4. Does not plan to move home in the next 2 months 5. Is at the contemplative stage regarding having a smoke-free home and indicates that they feel it would be possible for their home to go smoke-free 6. Has a personal mobile phone, email address and some form of regular access to the internet (either by computer or smartphone) Exclusion Criteria: 1. Persons with low literacy level that would prevent understanding and following study instructions |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Institut Català d'Oncologia | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Hellenic Cancer Society, Istituto per lo Studio e la Prevenzione Oncologica, Public Health Agency of Barcelona, University of Aberdeen |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in air quality (pre-/post-intervention) | 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. | The intervention will last 1 month. Comparison of differences in PM2.5 average concentrations during the first week of intervention (day 1-7) and the last one (day 23-29) | |
Secondary | Changes in self-declared household smoking rules (pre-/post-intervention) | 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 their intention to change smoking behaviours in the home. A follow-up questionnaire will gather data on changes in smoking rules in the home. This questionnaire will be delivered at the end of the 30 day intervention period. | Pre-/post intervention (30 days) | |
Secondary | Effectiveness of the intervention (self-declared) | 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. Qualitative data will be gathered 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. | After the 30 days of the intervention (one time-point measurement) |
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