Development of the Smoking Cessation Service System for Communities.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- 3-Month Successful Smoking Cessation Rate
研究概览
简要总结
Brief Summary What is the purpose of this research? The goal of this study is to test a new method to help informal workers in Thailand quit smoking. The investigators seek to determine if a community-based system using digital tools (such as the Line app) is more effective than the standard care provided by local health centers.
How will the research happen?
The investigators will divide participants into two groups:
Intervention Group: This group will receive a new support system. Trained village health volunteers (VHVs) will offer brief advice and support. Participants will also receive messages and counseling through the Line application and a telephone "Quitline" (1600).
Comparison Group: This group will receive the standard care normally provided at local health centers.
The study takes place in Saraburi, Thailand, and lasts for approximately 3 months.
Who can take part?
The study team is seeking individuals who:
Are between 18 and 60 years old.
Work in jobs without formal contracts (informal workers), such as street vendors or farmers.
Currently smoke cigarettes.
Own a smartphone with internet access.
What are the research questions?
The investigators will measure four primary outcomes after 3 months to evaluate the effectiveness of the new system:
The number of smokers who received sufficient information to decide to quit.
The number of participants who intend to quit smoking.
The number of participants who successfully quit smoking (confirmed by a breath test).
The cost and value of the program compared to the health benefits gained.
详细描述
Detailed Description Background and Rationale Tobacco use remains the leading cause of preventable mortality globally, accounting for approximately 8 million deaths annually. In Thailand, smoking is the third most significant risk factor for healthy life-year loss, imposing an economic burden of 87,250 million baht (0.56% of GDP). Despite national efforts, Health Region 4-particularly Saraburi Province-exhibits some of the lowest smoking screening and cessation success rates in the nation, with 6-month quit rates as low as 0.15% to 0.00% in certain areas.
The "New Normal" era, following the COVID-19 pandemic, has highlighted the need for resilient, digitally-integrated health services. Traditional hospital-based smoking cessation clinics often fail to reach "informal workers"-a vulnerable demographic (e.g., street vendors, construction laborers, farmers) who lack formal social security, earn low wages, and face significant time and transportation barriers to accessing clinic-based care.
Study Framework
This study employs Andersen's Behavioral Model of Health Services Use (ABMHSU) to analyze and address barriers to service utilization. The model categorizes influences into three factors:
Predisposing Factors: Demographic traits, social structures, and health beliefs.
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
- Double (Participant, Care Provider)
盲法说明
The Statistician and the Research Analysis Team are masked to the group allocation during the statistical processing phase to minimize analysis bias. To ensure the integrity of the results, the randomization code and group assignments are kept in sealed envelopes and are not revealed to the personnel performing the analysis until all statistical tests are finalized. The statistician evaluates the primary and secondary outcomes using coded identifiers (e.g., Group A and Group B) without knowledge of which cluster received the "New Normal" system intervention. Unblinding occurs only after the final analysis is complete and the research team has reached a unanimous consensus on the interpretation of the findings.
Due to the behavioral nature of the community-based intervention (use of the Line Application and Village Health Volunteer home visits), it is not possible to mask the investigators and outcome assessors during the implementation phase.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informal worker, defined as an individual engaged in an occupation outside the formal employment system, typically lacking social security benefits or formal employment contracts (e.g., street vendors, agricultural laborers, motorcycle taxi drivers, freelancers).
- •Current smoker, defined as an individual who has smoked at least one cigarette daily or non-daily within the past 30 days.
- •Residing in the study area (Mueang Saraburi District) for at least 3 months prior to enrollment.
- •Owns a smartphone with reliable internet access and is proficient in using mobile applications (specifically the Line Application).
- •Able to speak, read, and communicate clearly in Thai.
- •Willing and able to provide written informed consent to participate in the full duration of the 6-month study.
排除标准
- •Individuals currently participating in other smoking cessation programs or concurrent clinical research studies.
- •Individuals with physical or mental health conditions that may impair their ability to provide accurate information or consistently participate in digital follow-up (e.g., severe cognitive impairment, advanced terminal illness).
- •Planning to relocate outside the designated study area within the next 6 months.
研究组 & 干预措施
Smoking Cessation Service System in communities
Participants in this arm receive a multi-component smoking cessation intervention designed for the "New Normal" era. Key features include: (1) Task Redistribution: Village Health Volunteers (VHVs) act as the frontline for household screening and initial advice; (2) Digital Health: Continuous monitoring and motivational support via the Line Application and digital education prescriptions; and (3) Integrated Therapy: suggestion of traditional Thai herbal medicine (Vernonia cinerea tea) combined with behavioral techniques like Cognitive Behavioral Therapy (CBT) and Motivational Interviewing (MI).
干预措施: Smoking cessation in communities (Other)
Standard Care Service System
Participants in this arm receive the standard smoking cessation services currently available at sub-district health promotion hospitals in Thailand. This includes routine brief advice from healthcare providers when participants visit the clinic and a possible referral to hospital-based smoking cessation clinics if applicable. This arm does not include active community-level screening by VHVs, proactive digital follow-up through the Line Application, or the specific integration of the herbal intervention.
干预措施: Standard Care for Smoking Cessation (Other)
结局指标
主要结局
3-Month Successful Smoking Cessation Rate
时间窗: 3 months after the initial intervention.
Assessed using the Fagerström Test for Nicotine Dependence (FTND), a 6-item validated questionnaire. Scores range from 0 to 10; a score of 0-2 indicates very low dependence, while 8-10 indicates very high dependence, and the proportion of participants who achieve continuous abstinence from smoking for 3 months. Success is defined by self-reported 7-day point prevalence abstinence (no smoking in the last 7 days) and is biochemically verified by an exhaled carbon monoxide (CO) concentration of less than 10 ppm measured using a piCO+ Smokerlyzer® device.
Coverage of Information for Decision-Making
时间窗: 3 months post-intervention.
The proportion of smokers who have received comprehensive information regarding tobacco hazards and cessation benefits, as measured by the National Adult Tobacco Survey (NATS) 5-point scale. This indicator reflects the effectiveness of the community-led digital communication strategy.
Intention to Quit rate
时间窗: Baseline and 3 months post-intervention.
Measured using the Motivation to Stop Scale (MTSS), which assesses the participant's stage of change. Scores range from 1 (Pre-contemplation: not thinking about quitting) to 5 (Maintenance: quit more than six months ago). A higher score indicates a higher level of motivation and readiness to quit.
次要结局
未报告次要终点