Feasibility of a Diabetes Specialist Nurse-led Smoking Cessation Intervention

NCT05920096 | Completed

• 1 other identifier: V_15062020 8618
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Intervention Study; Feasibility Studies; Acceptability; Information Motivation Behavioral Skills Model; Counselling; Smoking Cessation Agents; 5A's Framework

Outcome Measures

Primary Outcomes (27)

• Feasibility (recruitment parameters) - recruitment rate

  The average number of eligible participants recruited per month.

  Baseline

• Feasibility (recruitment parameters) - the proportion of eligible smokers who indicate an interest in participating in the study from each source of recruitment

  Sources of recruitment include: the diabetes education unit and the diabetes and endocrine centre \[(MOP2) and self-referral (from posters and flyers present at the diabetes out-patients department).

  Baseline

• Feasibility (recruitment parameters) - consent rate

  The proportion of participants who consent to participate to the study out of the number of individuals who initially indicated an interest in participating and meet the eligibility criteria, including reasons for not consenting.

  Baseline

• Feasibility (recruitment parameters) - the total time period of recruitment

  Total time period (in months).

  Baseline

• Feasibility (participation compliance) - participation rate in both groups

  The proportion of participants who attend the scheduled sessions per group, with reasons for dropping out.

  12 weeks

• Feasibility (participation compliance) - the proportion/number of participants from the intervention group who opt not to see the informational video clips

  The proportion/number of participants from the intervention group who opt not to see the informational video clips at their first session, with reasons.

  12 weeks

• Feasibility (participation compliance) - the proportion/number of participants from the intervention group who opt not to set a Target Quit Date (TQD)

  The proportion/number of participants from the intervention group who opt not to set a TQD at their first session, with reasons.

  12 weeks

• Feasibility (participation compliance) - the proportion/number of continuing smokers from the intervention group who opt not to set a subsequent TQD

  The proportion/number of continuing smokers from the intervention group who opt not to set a subsequent TQD at their second session, with reasons.

  12 weeks

• Feasibility (participation compliance) - reported use of Nicotine Replacement Therapy (NRT) on the TQD in the intervention group

  The proportion of participants who report having used the nicotine patch and/or spray on their TQD (and on the subsequent TQD for continuing smokers), with reasons for not using it.

  12 weeks

• Feasibility (participation compliance) - average percentage of days of NRT use during the first week following the TQD in the intervention group

  The average percentage of days the nicotine patch and/or spray were used during the first week following the TQD (and the subsequent set TQD among continuing smokers).

  12 weeks

• Feasibility (participation compliance) - average use of the nicotine spray per day during the first week following the TQD in the intervention group

  The average number of times the nicotine spray was used per day during the first week following the TQD (and the subsequent TQD for continuing smokers).

  12 weeks

• Feasibility (participation compliance) - reported use of NRT during the final follow-up period in the intervention group

  The proportion of participants who report having used the nicotine patch and/or spray during their final follow-up period, with reasons for not using it.

  12 weeks

• Feasibility (participation compliance) - average percentage of days of NRT use during the final follow-up period in the intervention group

  The average percentage of days the nicotine patch and/or spray were used during the subsequent four weeks following one week from the TQD.

  12 weeks

• Feasibility (participation compliance) - average use of the nicotine spray per day during the final follow-up period in the intervention group

  The average number of times the nicotine spray was used per day during the subsequent four weeks following one week from the TQD.

  12 weeks

• Feasibility (resources utilized) - average number of sessions provided in both groups

  The average number of sessions provided per participant per group.

  12 weeks

• Feasibility (resources utilized) - average time period taken to provide smoking cessation support in both groups

  The average time period (in weeks) per participant per group during which smoking cessation support was provided.

  12 weeks

• Feasibility (resources utilized) - average time taken to deliver the sessions in the intervention group

  The average time (in minutes) taken to deliver the intervention sessions.

  12 weeks

• Feasibility (resources utilized) - provision of the 5R's intervention in the intervention group

  The proportion/number of participants from the intervention group who were provided with the 5R's intervention.

  12 weeks

• Feasibility (resources utilized) - provision of NRT in the intervention group

  The average amount of NRT provided per participant (taking note of any returned items).

  12 weeks

• Feasibility - response rate at 12 weeks follow-up

  The proportion of participants who attend their 12-week post-intervention evaluation session (in the intervention and control groups). Participants who drop out from the study or are lost to follow-up at 12 weeks will be noted (with reasons).

  12 weeks

• Feasibility - number of problems (including reported adverse events when using NRT) identified by the nurses (intervention providers) and number of referrals to additional support services (e.g. psychotherapist, diabetologist).

  As logged by the nurses in carrying out the intervention. Participants who refuse additional support will be noted (with reasons).

  through study completion, estimated at 12 months

• Feasibility - nurses' (intervention providers) perceived challenges and facilitators to implementation (intervention group)

  As identified when conducting interviews with the nurses.

  through study completion, estimated at 12 months

• Acceptability - intervention group participants' satisfaction with the intervention provided (quantitative assessment)

  By analyzing the results from the self-developed satisfaction questionnaire.

  12 weeks

• Acceptability - intervention group participants' satisfaction with the intervention provided (qualitative assessment)

  As identified when conducting interviews with the participants.

  12 weeks

• Acceptability - intervention group participants' perceived usefulness of the intervention provided (quantitative assessment)

  By analyzing the results from the self-developed perceived usefulness questionnaire.

  12 weeks

• Acceptability - intervention group participants' perceived usefulness of the intervention provided (qualitative assessment)

  As identified when conducting interviews with the participants.

  12 weeks

• Acceptability - nurses' (intervention providers) satisfaction with the intervention

  As identified when conducting interviews with the nurses.

  through study completion, estimated at 12 months

Secondary Outcomes (8)

• Group comparison of the satisfaction with the intervention provided

  12 weeks

• Group comparison of the perceived usefulness of the intervention provided

  12 weeks

• Preliminary process evaluation - intervention fidelity (intervention group)

  through study completion, estimated at 12 months

• Preliminary process evaluation - exploring the intervention's functioning (intervention group)

  12 weeks

• Preliminary evidence of effectiveness - quit episode

  12 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

A diabetes specialist nurse-led multi-component smoking cessation intervention tailored for individuals with diabetes based on evidence and theory and guided by the 5A's and 5R's framework for smoking cessation The intervention consists of three to four (30-60 minutes) smoking cessation support sessions which are to be delivered by the two diabetes specialist nurses at the Diabetes Education Unit during the study period (12 weeks). As part of the first session, participants will also be shown three very brief video clips in which a person living with diabetes explains the serious health problems he suffered from (when smoking and having diabetes). Participants will also receive a six-week supply of Nicotine Replacement Therapy (NRT) - nicotine patch and/or nicotine spray.

Other: Diabetes specialist nurse-led multi-component smoking cessation intervention

Control

ACTIVE COMPARATOR

Active referral to the Health Promotion and Disease Prevention Directorate's one-to-one general stop-smoking service. This counseling service is provided every fortnight within Mosta, Floriana, or Paola health centres. The number of counseling sessions (lasting around 20 minutes each) provided during the study period (12 weeks) will be based on the client's needs.

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

Interventions

Diabetes specialist nurse-led multi-component smoking cessation intervention OTHER

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.

Intervention

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

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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Living with type 1 or type 2 diabetes and attending the Diabetes Education Unit or the Diabetes and Endocrine Centre (MOP2) at Mater Dei Hospital on an outpatient basis
• Having smoked ≥100 cigarettes during his/her entire life and currently smoking (having at least smoked one tobacco product over the past 7 days)
• Being ≥ 18 years old
• Speaking and understanding English or Maltese
• Able to provide written informed consent

You may not qualify if:

• Not being able to provide informed consent (due to dementia, a learning disability, or a psychological disorder)
• Being pregnant or breastfeeding
• Unable to independently attend to the Diabetes Education Unit and the Mosta, Floriana, or Paola health centres in Malta during the 12-week study period
• Currently enrolled in another smoking cessation study/program or multi-behavioral program which also focuses on smoking cessation
• Enrolment of the investigator or the research collaborators, and their family members

Sponsors & Collaborators

• University of Malta: lead

Study Sites (1)

Diabetes Education Unit, Mater Dei Hospital

Msida, Malta

Location

Related Publications (5)

• Grech J, Norman IJ, Sammut R. Helping smokers with diabetes quit: A scoping review of the interventions utilised, and the challenges and barriers to smoking cessation. Prim Care Diabetes. 2023 Apr;17(2):119-128. doi: 10.1016/j.pcd.2023.01.005. Epub 2023 Jan 19.

  PMID: 36681570 BACKGROUND

• Grech J, Norman IJ, Sammut R. Effectiveness of intensive stand-alone smoking cessation interventions for individuals with diabetes: A systematic review and intervention component analysis. Tob Induc Dis. 2023 May 10;21:57. doi: 10.18332/tid/162329. eCollection 2023.

  PMID: 37181460 BACKGROUND

• Grech J, Norman IJ, Sammut R. Exploring the smoking cessation needs of individuals with diabetes using the Information-Motivation-Behavior Skills model. Tob Prev Cessat. 2024 Feb 2;10. doi: 10.18332/tpc/181366. eCollection 2024.

  PMID: 38313659 BACKGROUND

• Grech J, Norman I, Azzopardi C, Grixti M, Sammut R. 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. BMJ Open. 2024 Jun 19;14(6):e083235. doi: 10.1136/bmjopen-2023-083235.

  PMID: 38904126 BACKGROUND

• Grech J, Norman IJ, Sammut R. Acceptability measures for evaluating smoking cessation interventions among individuals with diabetes. Public Health Pract (Oxf). 2024 Mar 2;7:100487. doi: 10.1016/j.puhip.2024.100487. eCollection 2024 Jun.

  PMID: 38486708 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Tobacco Use Cessation

Interventions

Health Promotion; Standard of Care

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Joseph Grech, PhD student

  University of Malta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: June 27, 2023
• Study Start: August 1, 2023
• Primary Completion: October 7, 2024
• Study Completion: October 14, 2024
• Last Updated: November 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)