Condition category
Mental and Behavioural Disorders
Date applied
12/09/2016
Date assigned
09/12/2016
Last edited
09/12/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Sponsor information

Organisation

University of Bristol

Sponsor details

Senate House
Tyndall Avenue
Bristol
BS8 1TH
United Kingdom

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes