Plain English Summary
Background and study aims
It has been understood for some time now that environmental tobacco smoke (ETS) is harmful to the health of those breathing it in, particularly so in the case of young children. Children often breathe in ETS because their parents smoke and they are at particular risk of ETS if their mother smokes. It is not clear at the moment whether programmes (or interventions) developed to reduce the amount of ETS that children breathe in actually work. This study is testing a programme called the Smokefree Homes Service that will shortly be made available across the city of Stoke-on-Trent and that uniquely consists of telephone support, self-help materials and Nicotine Replacement Therapy (NRT)
Who can participate?
Households that agree to participate in the Smokefree Homes Service.
What does the study involve?
Potential participants/households are identified and , as long as they are happy to take part, they are randomly allocated a “time to intervention” by the researcher. This means that the time at which they start the Smokefree Homes Service during the study period will be at random. All participants do receive the Smokefree Homes Service at some point, however. This includes support via telephone, being provided with self-help materials and being given NRT. They are also given access to various training and support from a number of organisations. The programme runs for a total of 12 weeks.
What are the possible benefits and risks of participating?
Potential benefits to participants include being able to share their experience of the service and whether it has helped them to make their home smoke free. There are no risks beyond the inconvenience of organizing home visits during the study.
Where is the study run from?
University of Bristol (UK)
When is the study starting and how long is it expected to run for?
August 2016 to May 2017
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Dr Frank de Vocht
frank.devocht@bristol.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Frank de Vocht
ORCID ID
http://orcid.org/0000-0003-3631-627X
Contact details
School of Social and Community Medicine
University of Bristol
Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom
00441179287239
frank.devocht@bristol.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Protocol number 1
Study information
Scientific title
Stoke-on-Trent Smokefree Homes Service Evaluation: a stepped-wedge cluster randomised controlled trial
Acronym
SSHSE
Study hypothesis
Participation in the service leads to statistically significant reduction in indoor smoking, measured by:
1. Self-reported behavioural change
2. Indoor smoking-related particulate matter concentrations
Ethics approval
University of Bristol Health Sciences Faculty Research Ethics Committee, 05/08/2016, ref: 39241
Study design
Single-centre stepped-wedge cluster randomised trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Community
Trial type
Other
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Self-reported home indoor tobacco smoking, 24hr indoor air pollution (PM2.5) concentration, and carbon monoxide concentration in exhaled air (all family members aged 16 years or older).
Intervention
Receiving/participating in Smokefree Homes Service:
1. Telephone behavioural support
2 Self-help materials for 12 weeks plus Nicotine Replacement Therapy (NRT), sent by post to support temporary abstinence from smoking
3. Training and support for frontline staff from a range of organisations
Every participant will receive the intervention, but time-to-start will be randomized (randomization done by PI)
Intervention type
Behavioural
Phase
Drug names
Primary outcome measures
Successful smokefree home at the end of follow-up (8 month maximum). The a priori cut-off to define “smokefree” is based on:
1.1. Self-reported cessation of smoking of all family members, assessed by a questionnaire
OR
1.2. Self-reported cessation of indoor smoking (with or without use of nicotine patches), assessed by a questionnaire
AND
2. Average 24-hr average PM2.5 indoor concentration <50% of pre-intervention measurement, measured using the air quality monitor Dylos DC1700
Secondary outcome measures
1. Pre/post intervention difference in 24-hr average indoor PM2.5 concentration, measured using the air quality monitor Dylos DC1700
2. Amount of carbon monoxide (CO) in exhaled air (as a measure of individual health benefit and to confirm self-reported smoking cessation. CO in exhaled air of family members will be measured using the Bedfont Micro+ Smokerlyzer
Measured pre/post intervention.
Overall trial start date
20/08/2016
Overall trial end date
01/05/2017
Reason abandoned
Eligibility
Participant inclusion criteria
1. Every household that has agreed to participate in the Smokefree Homes Service
2. Household members aged 16 years or older
Participant type
Mixed
Age group
Adult
Gender
Both
Target number of participants
80 households
Participant exclusion criteria
1. Not participating in Smokefree Homes Service
2. Younger than 16 years of age
Recruitment start date
01/09/2016
Recruitment end date
01/02/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Bristol
School of Social and Community Medicine
Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Funder name
Public Health England
Alternative name(s)
PHE
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
The researchers anticipate five deliverables of the PHES by the end of the project (2018):
1. A final report will be prepared for dissemination for peer-review to NIHR
2. A distilled version of the final report will be written as a journal article to be submitted to an international peer-review journal in open access format
3. For fast dissemination and knowledge transfer to the academic community, we anticipate a presentation at an appropriate conference (to be determined)
4. We further aim to present at an even or events (conference/regional meeting) for local authority (to be determined)
5. A summary briefing paper will be made available for knowledge transfer to local authorities
Intention to publish date
30/03/2018
Participant level data
Not expected to be available
Results - basic reporting
Publication summary