Stoke-on-Trent smokefree homes service evaluation
| ISRCTN | ISRCTN98699098 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98699098 |
| Secondary identifying numbers | Protocol number 1 |
- Submission date
- 12/09/2016
- Registration date
- 09/12/2016
- Last edited
- 26/04/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Scientific
School of Social and Community Medicine
University of Bristol
Canynge Hall, 39 Whatley Road
Bristol
BS8 2PS
United Kingdom
 ORCID ID |
0000-0003-3631-627X |
|---|---|
| Phone | 00441179287239 |
| frank.devocht@bristol.ac.uk |
Study information
| Study design | Single-centre stepped-wedge cluster randomised trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Community |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Stoke-on-Trent Smokefree Homes Service Evaluation: a stepped-wedge cluster randomised controlled trial |
| Study acronym | SSHSE |
| Study objectives | 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(s) | University of Bristol Health Sciences Faculty Research Ethics Committee, 05/08/2016, ref: 39241 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 20/08/2016 |
| Completion date | 01/05/2017 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 80 households |
| Total final enrolment | 0 |
| Key inclusion criteria | 1. Every household that has agreed to participate in the Smokefree Homes Service 2. Household members aged 16 years or older |
| Key exclusion criteria | 1. Not participating in Smokefree Homes Service 2. Younger than 16 years of age |
| Date of first enrolment | 01/09/2016 |
| Date of final enrolment | 01/02/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom
Sponsor information
University/education
Senate House
Tyndall Avenue
Bristol
BS8 1TH
England
United Kingdom
"ROR" |
https://ror.org/0524sp257 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Government organisation / National government
- Alternative name(s)
- PHE
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/03/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| 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 |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 26/04/2021 | 26/04/2021 | No | No |
Additional files
- ISRCTN98699098_BasicResults_26Apr2021.pdf
- Uploaded 26/04/2021
Editorial Notes
26/04/2021: The following changes have been made:
1. The basic results of this trial have been uploaded as an additional file.
2. The final enrolment number has been added from the basic results summary.
