Development and feasibility testing of a multi-component smoking cessation intervention for smokers living with diabetes mellitus

Abstract

Background: Tobacco smoking increases the risk of macro- and micro-vascular complications for individuals living with diabetes. While smoking cessation has been recognised as an integral part of diabetes management, evidence of effective interventions is limited, and often this is overlooked by diabetes educators. Smokers with diabetes tend to be less motivated to stop, leading to low participation and abstinence rates. Aim: To develop a multi-component smoking cessation intervention grounded in theory and evidence, tailored for smokers with diabetes, and to assess its feasibility, acceptability, and potential effectiveness in preparation for a future definitive trial. Methods: In the development phase, a scoping review on the smoking cessation interventions that have been utilised amongst individuals with diabetes, and the faced challenges, and barriers was undertaken. A systematic review of effectiveness of the identified promising interventions followed, for identifying the components of the successful interventions. A qualitative descriptive study on the views of Maltese individuals living with diabetes of the identified components and their needs to quit smoking led to the development of the intervention. In the feasibility phase, a feasibility trial and its pilot were undertaken. A randomised trial with a nested qualitative descriptive study was undertaken to assess the feasibility and acceptability of the intervention amongst individuals with type 1 and type 2 diabetes (n=91) and two diabetes nurse educators (intervention providers) at a Maltese acute public hospital, comparing intervention acceptability and potential effectiveness to standard care. Results: A unique multi-component smoking cessation intervention consisting of 3-4 behavioural support sessions and a 6-week provision of Nicotine Replacement Therapy (NRT) was developed. Minor revisions were required following the pilot study, mainly the addition of a final follow-up session for continuing smokers. While treatment discontinuation was high in both groups in the feasibility trial, the intervention was found to be feasible, acceptable to the individuals with diabetes and the diabetes nurse educators, and potentially effective. The provision of NRT was identified as a crucial component of the intervention. Conclusions: The developed intervention is feasible and acceptable and may improve smoking quit rates when compared to standard care. To improve participation rates for a definitive trial, telephone-based follow-up support should be provided to those who struggle to attend further. Given NRT’s contributing role, the cost coverage or provision of NRT to smokers with diabetes is also recommended.