Feasibility of a Diabetes Specialist Nurse-led Smoking Cessation Intervention

Summary

The goal of this clinical trial is to assess the feasibility and acceptability of a multi-component smoking cessation intervention for individuals living with diabetes which is delivered by diabetes specialist nurses. The main question it aims to answer is:

Is a diabetes specialist nurse-led multi-component smoking cessation intervention tailored for persons living with diabetes who smoke feasible and acceptable among the providers and the participants, the individuals with diabetes?

Eligible individuals living with diabetes who smoke will be asked to participate in a feasibility study lasting twelve weeks. The participants will be allocated at random either to the diabetes specialist nurse-led multi-component smoking cessation intervention, or to standard care - an active referral to the Health Promotion and Disease Prevention Directorate's one-to-one smoking cessation service. The multi-component smoking cessation intervention will be provided by the diabetes specialist nurses at the Diabetes Education Unit at Mater Dei Hospital. The Health Promotion and Disease Prevention Directorate's one-to-one smoking cessation service is provided by tobacco cessation facilitators within the health centres of Mosta, Floriana, and Paola. Both interventions will help participants re-consider their smoking habits and support them to quit smoking, free of charge.

Primarily the researchers will:

* assess the feasibility of a largescale randomized controlled trial, by analyzing the recruitment and study uptake, and the nurses' perceived challenges and facilitators to implementation;
* and assess the acceptability of the intervention, by analyzing the nurses' feedback and the participants' satisfaction with and perceived usefulness of the smoking cessation intervention provided, in comparison to the satisfaction with standard care - the Health Promotion and Disease Prevention Directorate's one-to-one smoking cessation service.

Conditions

• Diabetes Mellitus
• Tobacco Use Cessation

Interventions

OTHER

Diabetes specialist nurse-led multi-component smoking cessation intervention

Aims to: * inform participants on the association between smoking and diabetic complications; * motivate and encourage smokers to quit; * support participants in using the appropriate behavioural skills to quit smoking and avoid relapse. In the first session, the participants will be supported to set a Target Quit Date (TQD) within two weeks. Participants will be followed up within a week (or two weeks max.) from their TQD. Those who report having not smoked (for ≥24 hours from the time of assessment) will be provided with a final follow-up session within five weeks from their set TQD (three sessions in total). Conversely, those who report still smoking will be encouraged to set another TQD and will be seen again in one (or two weeks max.) and five weeks from their new TQD (four sessions in total). The participants will also receive a six-week supply of Nicotine Replacement Therapy (NRT) nicotine patch and/or spray to use for a few days prior to their TQD and on quitting.

BEHAVIORAL

Health Promotion and Disease Prevention Directorate's one-to-one smoking cessation service (standard care)

A behavioral smoking cessation intervention based on motivational interviewing and delivered by trained tobacco cessation facilitators within community health centres. Participants will be provided with 20-minute counseling sessions based on their needs.

Sponsors & Collaborators

• University of Malta

  lead OTHER

Principal Investigators

• Joseph Grech, PhD student · University of Malta

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-08-01

Primary Completion

2024-10-07

Completion

2024-10-14

Countries

• Malta

Study Locations