Background Tobacco use is the leading cause of preventable death worldwide. In Ireland almost 6000 smokers dye each year from smoking-related diseases. ‘We Can Quit2’ (WCQ2 is a pilot pragmatic two-arm, parallel group, cluster randomised trial of a community-based peer-led smoking cessation intervention for women living in disadvantaged areas. The aim is to explore feasibility and acceptability of trial processes including recruitment and retention rates. A future trial will assess the effectiveness on short and medium-term cessation rates.
Methods Four matched pairs of districts (eight clusters) selected by area level of deprivation, geographical proximity, and eligibility for free medical services were randomised to receive either WCQ (behavioural support + access to Nicotine Replacement Therapy (NRT)) delivered over 12 weeks by trained Community Facilitators (CFs) or to a one-to-one smoking cessation service delivered by health professionals from Ireland’s Health Service Executive (HSE). Recruitment target: 24–25 women per cluster (97 per arm; 194 in total) in four waves with consent obtained prior to randomisation. Primary outcome: achievement of recruitment target. Secondary outcomes included retention and data completion rates at 12 weeks(w) and 6 months(m) post-quit date and proportion continuously absent from smoking at 12w (primary outcome for a future DT) and at 6m, (self-report +biochemical validation). Acceptability of trial processes and intervention delivery was assessed by interview with participants and community facilitators.
Results 125/208 registered women consented to participate (60.1%), 64.4% of the recruitment target (125/194). Recruitment was an iterative process and the target number (48) was reached in wave 4. Dropout rates were high, 67/125 (53.6%) at 12w and 59/125 (47.2%) at 6m. While the study was not powered to test effectiveness, 26.6% of women randomised to the intervention group were non-smokers at 12 weeks versus 16.6% of controls. Higher quit rates were observed in the intervention group, (41.7% intervention, 25.8% control) in those who attended at least one delivery session (89). Differences in quit rates were not sustained at 6/12. High acceptability of trial processes and intervention delivery were reported.
Conclusion Recruitment to a community based smoking cessation pilot RCT for disadvantaged women was challenging but feasible. Challenges to recruitment and lessons learned will be discussed. A positive direction of effect in favour of the intervention was noted. Measures to improve retention rates are needed in a future definitive intervention trial.
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