Abstract
IntroductionSmoking cessation is an essential, but often overlooked aspect of diabetes management. Despite the need for tailored smoking cessation support for individuals with diabetes, evidence of effective interventions for this cohort is limited. Additionally, individuals with diabetes do not easily adopt such interventions, resulting in low uptake and abstinence rates. This protocol describes a study that aims to assess the feasibility and acceptability of a unique smoking cessation intervention, based on the best evidence, theory and the needs of individuals with diabetes, among patients and service providers, the diabetes nurse educators.Methods and analysisThis is an open-label pragmatic randomised controlled trial. Between 80 and 100 individuals with type 1 or type 2 diabetes who smoke will be recruited from the diabetes outpatients at the main acute public hospital in Malta, starting in August 2023. Participants will be randomly assigned (1:1 ratio) to the intervention or control arm for 12 weeks. The experimental intervention will consist of three to four smoking cessation behavioural support sessions based on the 5As (Ask, Advise, Assess, Assist and Arrange) algorithm, and a 6-week supply of nicotine replacement therapy. The control intervention will consist of an active referral to the Maltese National Health Service’s one-to-one smoking cessation support service, which is based on motivational interviewing. The primary feasibility and acceptability outcomes include the recruitment and participation rates, resources used, problems identified by the nurses, the nurses’ perceived challenges and facilitators to implementation and the nurses’ and patients’ acceptability of the study intervention. Data analyses will be descriptive, with quantitative feasibility and acceptability outcomes reported with 95% confidence intervals.Ethics and disseminationEthical clearance was obtained from the Faculty of Health Sciences Research Ethics Committee, University of Malta. The study results will be disseminated through conference presentations and a publication in a peer-reviewed journal.Trial registration numberNCT05920096.
Funder
the Tertiary Education Scholarships Scheme, Ministry for Education, Sport, Youth, Research
Reference92 articles.
1. Boyko EJ , Magliano DJ , Karuranga S , et al . IDF diabetes Atlas 10th Ed. International Diabetes Federation 2021.
2. Lotrean LM . Smoking cessation in patients with diabetes. In: Behrakis P , Vardavas C , Papadakis S , eds. Tobacco Cessation Guidelines for High-Risk Populations. 2017: 150–91.
3. Relationship of cardiometabolic parameters in non-smokers, current smokers, and quitters in diabetes: a systematic review and meta-analysis;Kar;Cardiovasc Diabetol,2016
4. Smoking and diabetes interplay: a comprehensive review and joint statement;Durlach;Diabetes Metab,2022
5. Smoking cessation, weight gain, and cardiovascular risk;Kos;Lancet Diabetes Endocrinol,2020