NCT03151421

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 12, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

2.7 years

First QC Date

March 30, 2017

Last Update Submit

August 23, 2019

Conditions

Keywords

air quality feedbacksecond-hand smokepassive smokingexposure to second-hand smokesecond-hand smoke exposure prevention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Changes in self-declared household smoking rules (pre-/post-intervention)

    Pre-/post intervention (30 days)

  • Effectiveness of the intervention (self-declared)

    After the 30 days of the intervention (one time-point measurement)

Study Arms (1)

Home air quality monitoring and feedback

EXPERIMENTAL

Home air quality monitoring and feedback

Behavioral: Home air quality monitoring and feedback

Interventions

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 voicecalls. 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.

Home air quality monitoring and feedback

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult (18 years or over) who smokes inside their home on a daily basis
  • Takes care of a child (16 years old or under) in their home at least once per week
  • Lives in a SIMD quintile 1 or 2 postcode or equivalent (i.e. within 40% most deprived households in their country)
  • Does not plan to move home in the next 2 months
  • 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
  • Has a personal mobile phone, email address and some form of regular access to the internet (either by computer or smartphone)

You may not qualify if:

  • \. Persons with low literacy level that would prevent understanding and following study instructions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Tobacco SmokingTobacco Use

Condition Hierarchy (Ancestors)

SmokingBehavior

Study Officials

  • Sean Semple, PhD

    University of Aberdeen, Respiratory Group, Division of Applied Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2017

First Posted

May 12, 2017

Study Start

September 1, 2016

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

August 28, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share