Smoking cessation Mental and Behavioural Disorders Smoking cessation
Conditions
Interventions
Four matched pairs of districts (eight clusters), will be randomised with each matched pair of clusters randomised to intervention or controls in a 1:1 allocation ratio. The randomisation will follow
this accounts for temporal changes over time and will provide a balanced design.
The randomisation will be conducted remotely by the Wellcome Trust Clinical Research Facility (CRF) ind
Sponsors
Trinity Research & Innovation, Trinity College Dublin
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Female 2. Aged 18 or over 3. English speaker 4. Self-reported as a daily smoker with an interest in quitting 5. Deemed to live/work within easy travel distance of the trial catchment areas Women taking Nicotine Replacement Therapy (NRT) or who are have been prescribed bupropion/varenicline by the doctor at time of recruitment are eligible to take part, as are women using e-cigarettes.
Exclusion criteria
Exclusion criteria: 1. Pregnant or planning a pregnancy in the near future 2. Enrolled in another smoking cessation study 3. Cannot travel to location of programme delivery 4. Do not have the capacity to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of recruitment, assessed by the number of women enrolled in the study as a proportion of the recruitment target of 194 women from eight randomised districts within 18 months during four 12 week periods | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Retention and data completion rates in each trial arm at 12 weeks and 6 months post quit date as a follow-up timepoint in the full trial. Retention will be measured as the number of women retained in the study by 12 weeks and six months post quit date as a proportion of the number of women enrolled. Data completion will be measured as the proportion of valid sets of outcome measures completed by women at 12 weeks and six months post quit date. 2. Proportion of participants who are continuously abstinent from smoking (as per Russell Standard), at 12 weeks. This will be measured by self-report corroborated by salivary cotinine and anabasine. 3. Proportion of participants who are continuously abstinent from smoking, at 6 months after their quit date, corroborated by salivary cotinine and anabasine. 4. Proportion of enrolled smokers who engage with smoking cessation services in each trial arm (engagement is defined as arrival for a first with a smoking cessation adviser and having set a quit date). This will be measured by the proportion of women who have set a quit date up to and including the second session with a smoking cessation advisor as a proportion of those who enrolled in the study 5. Proportion of participants who report improvement in health status measured at baseline (week 1) and 12 weeks and 6 months. This will be measured by calculating the number and percentage of responses for each item of the 12-item short-form health survey (SF-12) at week 1, week 12 and 6 months. Means, standard deviations (or their non-parametric alternative) will be estimated together with the corresponding change scores and effect sizes. 6. Fidelity to and adaptation of the intervention as established by Community Facilitator checklist and diary assessed at time of focus group interview at week 12. 7. Acceptability of trial processes by participants and practitioners | — |
Countries
Ireland
Outcome results
None listed