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临床试验/NCT05430789
NCT05430789招募中不适用

Nurse-led Post-discharge Cessation Support for Smoking Patients Using Mobile-based Intervention: a Randomized Controlled Trial

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 770 人开始时间: 2022年6月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
770
试验地点
1
主要终点
Biochemically-validated abstinence

研究概览

简要总结

This study aims to enhance the general 5As brief advice model with interactive mobile phone-based intervention and active referral to community smoking cessation services for smoking patients discharged from hospitals.

详细描述

Most smoking patients continue to smoke (76.1%) after being discharged from hospitals. Post-discharge smoking cessation (SC) support is one of the most cost-effective treatments. Hospitalisation offers a teachable moment to motivate patients to engage in post-discharge intervention, particularly those suffering from smoking-related diseases. Behavioral and psychosocial support increases abstinence in patients. Current clinical guidelines in the US (USPSTF) and UK (NICE) recommend health care professionals to provide brief SC support to patients using a brief advice model such as the 5As (Ask, Assess, Advice, Assist, Arrange) and further motivational 5Rs interventions (Relevance, Risks, Rewards, Roadblocks, and Repetition) if needed for those not having quit attempts. A key trial found that providing discharged patients with such proactive and sustained care as free SC medication, telephone calls to promote quitting, and additional counselling through clinic referrals increased 6-months validated quitting. Trained patient navigators providing patients in hospital primary clinics with tailored individual advice with medication and counselling referrals were found to be effective at improving 12-months quitting. Previous trials also showed connecting community smokers or smokers who visited emergency departments to existing SC services increased validated quitting at 6-months. Recent advances in mobile phone technology allow incorporating such innovations to improve the cost-effectiveness of post-discharge smoking cessation services.

Mobile phones are increasingly used for monitoring and delivering personalised health treatments (mHealth). Regular text messaging was found to increased 6-months validated abstinence in general smokers, although the study was limited to pre-defined messages and interactions. A previous study reported an automated interactive voice response to be favored by patients and to increase abstinence. A text-based programme was tested in a Chinese population, and previous study found the delivery of interactive chat-based SC support via IM apps to be effective in increasing quitting. Chat-based SC interventions can provide real-time, personalised behavioral support and referrals to SC services. Mobile health is also part of the World Health Organization's strategies to combat smoking.

Leveraging the success of previous trials in inpatients and a chat-based trial using IM to deliver behavioral support to community smokers, This study proposes to refine the 5As cessation model by incorporating a mobile phone-based intervention for patients recently discharged from hospitals. Recent trials showed a mobile phone-delivered cessation intervention combined with SC medication service increased abstinence. Recent trials showed a mobile phone-delivered cessation intervention combined with SC medication service increased abstinence. Active referral of community smokers to smoking cessation services increases service use and quitting but smoking patients were not referred for sustained cessation service in hospitals in Hong Kong. The effect of mobile phone-based intervention with active referral to link discharged patients for standard smoking cessation service remains unclear. Therefore, This study proposes to enhance the general 5As brief advice model with interactive mobile phone-based intervention and active referral to community smoking cessation services for smoking patients discharged from hospitals in Hong Kong.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

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

  • •Smokers who are hospitalised or waiting for discharge in Hong Kong
  • •Smoke cigarettes or alternative tobacco products (e.g. electronic cigarettes or heated tobacco products) daily at 1 month prior to hospitalisation
  • •Have a smartphone with an IM app (WhatsApp or WeChat) and experience in using the app
  • •Hong Kong adult residents (18+) able to communicate in Chinese (Cantonese or Mandarin)

排除标准

  • •Smokers not mentally fit for communication (e.g. psychiatry patients)
  • •Smokers currently using SC medication or other SC services
  • •Smokers hospitalised for more than 1 month
  • •Perceived difficulty to use IM after discharge

研究组 & 干预措施

Intervention group

Experimental

5As brief advice + Self-help ebooklet + Nurse-led mHealth intervention

干预措施: 5As brief advice (Behavioral)

Intervention group

Experimental

5As brief advice + Self-help ebooklet + Nurse-led mHealth intervention

干预措施: Self-help e-booklet (Behavioral)

Intervention group

Experimental

5As brief advice + Self-help ebooklet + Nurse-led mHealth intervention

干预措施: Nurse-led mHealth intervention (Behavioral)

Control group

Active Comparator

5As brief advice + Self-help ebooklet + Text messaging

干预措施: 5As brief advice (Behavioral)

Control group

Active Comparator

5As brief advice + Self-help ebooklet + Text messaging

干预措施: Self-help e-booklet (Behavioral)

Control group

Active Comparator

5As brief advice + Self-help ebooklet + Text messaging

干预措施: Regular intervention (Behavioral)

结局指标

主要结局

Biochemically-validated abstinence

时间窗: 12-month after baseline

Defined by exhaled carbon monoxide \< 4 parts per million (ppm) and salivary cotinine \< 30 ng/ml

Biochemically-validated abstinence

时间窗: 6-month after baseline

Defined by exhaled carbon monoxide \< 4 parts per million (ppm) and salivary cotinine \< 30 ng/ml

次要结局

  • Smoking cessation service use(12-month after baseline)
  • Smoking reduction(12-month after baseline)
  • Nicotine dependence level(12-month after baseline)
  • Self-reported past 7-day abstinence(12-month after baseline)
  • 24-weeks continuous abstinence(12-month after baseline)
  • Intention to quit(12-month after baseline)
  • Number of quit attempt(12-month after baseline)
  • Self-reported past 7-day abstinence(6-month after baseline)
  • 24-weeks continuous abstinence(6-month after baseline)
  • Intention to quit(6-month after baseline)
  • Number of quit attempt(6-month after baseline)
  • Smoking reduction(6-month after baseline)
  • Nicotine dependence level(6-month after baseline)
  • Smoking cessation service use(6-month after baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Wang Man-Ping

Associate Professor

The University of Hong Kong

研究点 (1)

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