Second hand smoke Respiratory Exposure to tobacco smoke
Conditions
Interventions
A trial will be conducted over 24 months in 45 mosques and their catchment communities in Mirpur area of Dhaka, Bangladesh. An effectiveness-implementation hybrid study design will be used that blends
II) process evaluation
and III) implementation and scale-up.
45 mosques are randomised to the three trial arms:
Arm 1 – M4bH and IAQ feedback
Arm 2 – M4bH alone
Sponsors
University of York
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Clusters: The study is to be conducted in 45 mosques and their catchment communities in Mirpur area of Dhaka, Bangladesh Eligibility criteria for mosques: 1. Be based in the residential parts of Mirpur, Dhaka 2. Host communal prayers (including Friday prayers) 3. At least half a kilometre from another cluster (participating mosques) 4. Be led by a Imam or Khateeb who is a self-reported non-smoker 5. Be enlisted with the Islamic Foundation (IF). These mosques will be under a government ministry and will be monitored by the government. This is important in the Bangladesh context The aim is to enroll a total of 1,800 households for the trial (average 40 per each participating mosque) For a household to be eligible for the study, it should have: 1. At least one resident attending one of the participating mosque 2. At least one adult resident who smokes cigarettes or other forms of smoked tobacco (e.g. biri, hukka, shisha) regularly (at least 25 out of 30 days/ month) 3. At least one non-smoking resident of any age 4. Not planning to move home in the next 12 months A resident is defined as an adult or child who has been staying in the home for 3 months and plans to stay at least 1 year in that home
Exclusion criteria
Exclusion criteria: A household is not eligible if: 1. It uses coal and/or biomass fuel for domestic use 2. The household head is unwilling/unable to give written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 14/01/2019: 24-hour mean household concentration of indoor fine particulate matter (PM2.5) at 12 months post randomisation: PM2.5 will be measured in homes using the Dylos DC 1700 (Dylos, California, USA) a low-cost particulate counter validated for use in domestic settings. Data from Scotland indicate that a smoke-free home will have PM2.5 concentrations that are generally about 5-10 times lower than a home where smoking takes place. Data from smokers’ homes in Scotland suggest that there is little difference between PM2.5 levels measured on the first day compared with levels measured over the following period of up to six days. This suggests that installation of these monitors for 24 hours will provide a good representation of SHS levels within that home. Previous primary outcome measure: Household SHS concentration, measured as fine Particulate Matter less than 2.5 microns diameter (PM2.5) at 3 months post-randomisation: PM2.5 will be measured in homes using the Dylos DC 1700 (Dylos, California, USA) a low-cost particulate counter validated for use in domestic settings. Data from Scotland indicate that a smoke-free home will have PM2.5 concentrations that are generally about 5-10 times lower than a home where smoking takes place. Data from smokers’ homes in Scotland suggest that there is little difference between PM2.5 levels measured on the first day compared with levels measured over the following period of up to six days. This suggests that installation of these monitors for 24 hours will provide a good representation of SHS levels within that home. | — |
Secondary
| Measure | Time frame |
|---|---|
| A number of secondary outcome measures will be used in this study. The following will be measured for the household: 1. SHS concentration measured as fine PM less than 2.5 microns diameter (PM2.5) at 6 months post-randomisation 2. Smoking restrictions at home: The level of smoking restrictions at home will be assessed through a questionnaire directed at the adults in the households at 3, 4, 5 and 6 months post-randomisation These will be measured for each member of the household: 3. Frequency and severity of respiratory symptoms: For participants aged 11 and over, Part 1 (eight questions) of the validated St George’s Respiratory Questionnaire (SGRQ) will be used to assess participants’ recollection of their respiratory symptoms over the preceding month at 3, 4, 5 and 6 months post-randomisation. SGRQ is a validated questionnaire and a Bangla translation is available for use. For participants younger than 11, respiratory symptoms will be assessed by another severity scale developed and validated by Chauhan et al at 3, 4, 5 and 6 months post-randomisation. 4. Quality of life, measured using EQ-5D29,30 for adults aged 18 and over, EQ-5DY for adolescents (11-17 years inclusive) and PedsQoL for children younger than 11 years, at 3 and 6 months post-randomisation 5. Health service use: number and type of contacts with doctors, hospital admissions, pharmacy visits and antibiotic prescriptions for all participants, collected using a health service utilisation questionnaire previously used in the MCLASS pilot trial. This will be assessed at 3 and 6 months follow-up. Resource use data for each member of the household will be collected in all three trial arms for utilisation of health care resources including physician visits, hospitalisations and medications using the service use questionnaires as developed in the MCLASS pilot. Quantities of resource use are multiplied by local | — |
Countries
Bangladesh
Outcome results
None listed