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Air Quality Feedback to Reduce Second-hand Smoke (SHS) Exposure in the Home (TackSHSWP4)

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ClinicalTrials.gov Identifier: NCT03151421
Recruitment Status : Active, not recruiting
First Posted : May 12, 2017
Last Update Posted : May 12, 2017
Sponsor:
Collaborators:
University of Aberdeen
Istituto per lo Studio e la Prevenzione Oncologica
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Hellenic Cancer Society
Public Health Agency of Barcelona
Information provided by (Responsible Party):
Institut Català d'Oncologia

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.


Condition or disease Intervention/treatment Phase
Second Hand Tobacco Smoke Tobacco Smoking Tobacco Use Behavioral: Home air quality monitoring and feedback Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Measuring for Change: Air Quality Feedback to Reduce Second-hand Smoke (SHS) Exposure in the Home
Actual Study Start Date : September 1, 2016
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : October 30, 2019

Arm Intervention/treatment
Experimental: Home air quality monitoring and feedback
Home air quality monitoring and feedback
Behavioral: Home air quality monitoring and feedback
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.




Primary Outcome Measures :
  1. Change in air quality (pre-/post-intervention) [ Time Frame: 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) ]
    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.


Secondary Outcome Measures :
  1. Changes in self-declared household smoking rules (pre-/post-intervention) [ Time Frame: Pre-/post intervention (30 days) ]
    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.

  2. Effectiveness of the intervention (self-declared) [ Time Frame: After the 30 days of the intervention (one time-point measurement) ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03151421


Sponsors and Collaborators
Institut Català d'Oncologia
University of Aberdeen
Istituto per lo Studio e la Prevenzione Oncologica
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Hellenic Cancer Society
Public Health Agency of Barcelona
Investigators
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Principal Investigator: Sean Semple, PhD University of Aberdeen, Respiratory Group, Division of Applied Health Sciences

Additional Information:
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Responsible Party: Institut Català d'Oncologia
ClinicalTrials.gov Identifier: NCT03151421     History of Changes
Other Study ID Numbers: TackSHS WP4
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: May 12, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Institut Català d'Oncologia:
air quality feedback
second-hand smoke
passive smoking
exposure to second-hand smoke
second-hand smoke exposure prevention