Assessing the feasibility and acceptability of a diabetes-specific nurse-led multicomponent smoking cessation intervention in diabetes education: study protocol for an open-label pragmatic randomised controlled trial

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 eas...

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Bibliographic Details
Published in:	BMJ open Vol. 14; no. 6; p. e083235
Main Authors:	Grech, Joseph, Norman, Ian, Azzopardi, Catherine, Grixti, Moira, Sammut, Roberta
Format:	Journal Article
Language:	English
Published:	England British Medical Journal Publishing Group 19-06-2024 BMJ Publishing Group LTD BMJ Publishing Group
Series:	Protocol
Subjects:	Cardiovascular disease clinical trial Diabetes Diabetes and Endocrinology Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 - therapy Drug therapy Feasibility Studies general diabetes Health care health education Humans Intervention Medical personnel Mortality Nicotine nurses Pandemics Patient Acceptance of Health Care Patient Education as Topic - methods Pragmatic Clinical Trials as Topic preventive medicine Smoking cessation Smoking Cessation - methods Systematic review Tobacco Malta clinical trial health education general diabetes feasibility studies nurses preventive medicine
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Summary:	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 number NCT05920096.
Bibliography:	Protocol ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 ObjectType-Undefined-3
ISSN:	2044-6055 2044-6055
DOI:	10.1136/bmjopen-2023-083235