Feasibility Assessment of a Diabetes Specialist Nurse-led Multi-component Smoking Cessation Intervention for Individuals Living With Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- Feasibility (resources utilized) - average number of sessions provided in both groups
研究概览
简要总结
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.
详细描述
BACKGROUND
Smoking cessation is an important aspect of diabetes management. Smoking worsens the cardiometabolic parameters of both individuals with type 1 and type 2 diabetes, significantly increasing the risk of various macro- and micro-vascular complications, and even death. Smoking cessation is associated with improved cardiometabolic values and a reduced risk of cardiovascular complications. However, evidence suggests that people living with diabetes may less likely quit smoking when compared to those without diabetes.
While the need for providing tailored smoking cessation support for those who have diabetes has been emphasized, evidence-based smoking cessation recommendations for such individuals are lacking. In addition, the literature suggests that diabetes educators tend to focus on other aspects of diabetes management, rather than tobacco use. Diabetes educators have reported feeling inadequately prepared in discussing smoking cessation amongst individuals with diabetes lacking motivation and time to do so.
STUDY AIM AND OBJECTIVES
The aim of this randomized controlled feasibility study is to establish the feasibility and acceptability of a diabetes specialist nurse-led smoking cessation intervention, based on evidence and theory, tailored for people living with diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Intervention
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.
干预措施: Diabetes specialist nurse-led multi-component smoking cessation intervention (Other)
Control
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.
干预措施: Health Promotion and Disease Prevention Directorate's one-to-one smoking cessation service (standard care) (Behavioral)
结局指标
主要结局
Feasibility (resources utilized) - average number of sessions provided in both groups
时间窗: 12 weeks
The average number of sessions provided per participant per group.
Feasibility (recruitment parameters) - recruitment rate
时间窗: Baseline
The average number of eligible participants recruited per month.
Feasibility (recruitment parameters) - the total time period of recruitment
时间窗: Baseline
Total time period (in months).
Feasibility (resources utilized) - average time period taken to provide smoking cessation support in both groups
时间窗: 12 weeks
The average time period (in weeks) per participant per group during which smoking cessation support was provided.
Feasibility (resources utilized) - provision of NRT in the intervention group
时间窗: 12 weeks
The average amount of NRT provided per participant (taking note of any returned items).
Feasibility (participation compliance) - the proportion/number of participants from the intervention group who opt not to see the informational video clips
时间窗: 12 weeks
The proportion/number of participants from the intervention group who opt not to see the informational video clips at their first session, with reasons.
Feasibility (participation compliance) - the proportion/number of participants from the intervention group who opt not to set a Target Quit Date (TQD)
时间窗: 12 weeks
The proportion/number of participants from the intervention group who opt not to set a TQD at their first session, with reasons.
Feasibility (participation compliance) - the proportion/number of continuing smokers from the intervention group who opt not to set a subsequent TQD
时间窗: 12 weeks
The proportion/number of continuing smokers from the intervention group who opt not to set a subsequent TQD at their second session, with reasons.
Feasibility (participation compliance) - average use of the nicotine spray per day during the final follow-up period in the intervention group
时间窗: 12 weeks
The average number of times the nicotine spray was used per day during the subsequent four weeks following one week from the TQD.
Feasibility (recruitment parameters) - the proportion of eligible smokers who indicate an interest in participating in the study from each source of recruitment
时间窗: Baseline
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).
Feasibility (recruitment parameters) - consent rate
时间窗: Baseline
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.
Feasibility (participation compliance) - participation rate in both groups
时间窗: 12 weeks
The proportion of participants who attend the scheduled sessions per group, with reasons for dropping out.
Feasibility (participation compliance) - reported use of Nicotine Replacement Therapy (NRT) on the TQD in the intervention group
时间窗: 12 weeks
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.
Feasibility (participation compliance) - average percentage of days of NRT use during the first week following the TQD in the intervention group
时间窗: 12 weeks
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).
Feasibility (participation compliance) - reported use of NRT during the final follow-up period in the intervention group
时间窗: 12 weeks
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.
Feasibility (participation compliance) - average percentage of days of NRT use during the final follow-up period in the intervention group
时间窗: 12 weeks
The average percentage of days the nicotine patch and/or spray were used during the subsequent four weeks following one week from the TQD.
Feasibility - response rate at 12 weeks follow-up
时间窗: 12 weeks
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).
Acceptability - intervention group participants' satisfaction with the intervention provided (quantitative assessment)
时间窗: 12 weeks
By analyzing the results from the self-developed satisfaction questionnaire.
Feasibility (participation compliance) - average use of the nicotine spray per day during the first week following the TQD in the intervention group
时间窗: 12 weeks
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).
Feasibility - nurses' (intervention providers) perceived challenges and facilitators to implementation (intervention group)
时间窗: through study completion, estimated at 12 months
As identified when conducting interviews with the nurses.
Feasibility (resources utilized) - provision of the 5R's intervention in the intervention group
时间窗: 12 weeks
The proportion/number of participants from the intervention group who were provided with the 5R's intervention.
Feasibility (resources utilized) - average time taken to deliver the sessions in the intervention group
时间窗: 12 weeks
The average time (in minutes) taken to deliver the intervention sessions.
Acceptability - intervention group participants' satisfaction with the intervention provided (qualitative assessment)
时间窗: 12 weeks
As identified when conducting interviews with the participants.
Acceptability - intervention group participants' perceived usefulness of the intervention provided (quantitative assessment)
时间窗: 12 weeks
By analyzing the results from the self-developed perceived usefulness questionnaire.
Acceptability - intervention group participants' perceived usefulness of the intervention provided (qualitative assessment)
时间窗: 12 weeks
As identified when conducting interviews with the participants.
Acceptability - nurses' (intervention providers) satisfaction with the intervention
时间窗: through study completion, estimated at 12 months
As identified when conducting interviews with the nurses.
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).
时间窗: through study completion, estimated at 12 months
As logged by the nurses in carrying out the intervention. Participants who refuse additional support will be noted (with reasons).
次要结局
- 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)
- Group comparison of the satisfaction with the intervention provided(12 weeks)
- Preliminary evidence of effectiveness - quit episode(12 weeks)
- Preliminary evidence of effectiveness - floating abstinence(12 weeks)
- Preliminary evidence of effectiveness - change in average number of cigarettes smoked per day(12 weeks)
- Preliminary evidence of effectiveness - point prevalence smoking abstinence at follow-up(12 weeks)
研究者
Joseph Grech
Principal Investigator
University of Malta