Children's exposure to second-hand smoke in the home Other
Conditions
Interventions
Intervention arm (Group A): Fifty participants are being randomly allocated to Group A. They receive a free, 12-week supply of nicotine replacement therapy posted to home, an information sheet on how
Sponsors
University of Stirling
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Parents, and carers and relatives 2. Aged at least 18 years old 3. Smokes in the home 4. Cares for one or more children aged or over in the home, at least 1 day per week, most days. 5. Multiple family members can participate in the study. 6. Individuals who are interested to take part but live with another adult smoker who does not wish to, are able to participate.
Exclusion criteria
Exclusion criteria: 1. Individuals who are not able to understand or speak English as their primary language are excluded given we do not have a budget to recruit, train and pay bilingual staff. 2. Individuals who use Warfarin, Theophylline or Aminophylline, Clozapine, Erlotinib, Olanzapine, Riociguat, Chlorpromazine, Flecainide, Methadone or Warfarin are excluded as NRT use would require GP monitoring. 3. Pregnant and breastfeeding women are excluded from participation as the NRT products offered are only licensed for this group of people who are making a quit attempt. 4. Participants who have a hypersensitivity to nicotine or any components of the nicotine replacement products offered in this study and listed in the product literature are excluded from taking part – we establish this by asking specific questions regarding any previous use of NRT and whether participants have any allergies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Recruitment, randomisation and retention: 1.1. Number of participants screened, eligible and successfully recruited into the study, and the characteristics of non-consenting and ineligible participants (measured using a baseline data collection tool and Excel recruitment tracker) 1.2. Number of participants enrolled in the allocated recruitment time (measured using an Excel recruitment tracker) 1.3. Retention of participants in their trial arms following randomisation, the proportion engaging in 12 week follow ups, and number/reasons for dropping out (measured using an Excel recruitment tracker). 2. Intervention delivery: 2.1. The proportion of participants (a) receiving NRT and demonstrating their adherence to NRT at fortnightly follow ups; and (b) engaging in fortnightly telephone support calls (all monitored by Excel participant tracker). 3. Data collection methods: Proportion of completed baseline and follow up assessments in each arm; Number of participants successfully providing child saliva samples and measuring air quality at baseline and 12 week follow up. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of cigarettes smoked per day (in general and in the home) (measured by baseline and follow up questionnaires) 2. Home smoking practices (measured by baseline and follow up questionnaires) 3. Self-reported quit attempts (measured by follow up questionnaire) 4. Nicotine dependence (measured at baseline and 12 week follow up using the Heaviness of Smoking Index). 5. We are also testing the feasibility of participants collecting saliva samples from their youngest child (age 5 or over) for cotinine analysis, and collection of resource use and economic data prior to a future definitive trial. | — |
Countries
Scotland, United Kingdom
Contacts
Public ContactRachel O'Donnell
Outcome results
None listed