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.
Enabling Factors: Resources such as digital literacy, family support, and community infrastructure.
Need Factors: Self-perceived health symptoms and evaluated nicotine dependence (measured via the Fagerström Test for Nicotine Dependence).
The Smoking Cessation Service System Intervention
The intervention group receives a multi-faceted community-based system developed through situation analysis and stakeholder engagement. The system is built on three core pillars:
Task Redistribution (Frontline Community Workforce): The study shifts the focus from hospital-centric care to community-led intervention. Village Health Volunteers (VHVs) act as the primary frontline, conducting household screenings and recording data via mobile applications. The Community Health Board (CHB), comprising local leaders and government officers, provides policy support and monitors progress. Professional Community Nurses serve as mentors, managing complex cases and pharmacological needs via digital consultations.
Efficient Digital Communication: To overcome accessibility barriers, the system utilizes the Line Application for two-way interactive communication. This platform facilitates:
Digital Education Prescriptions: Tailored motivational messages and knowledge sets based on the participant's stage of change.
Quitline 1600 Integration: Automated and manual links to the National Quitline for proactive counseling.
Peer Support Groups: Digital communities for social reinforcement and sharing experiences.
Integrated Behavioral and Herbal Interventions: The system combines evidence-based Cognitive Behavioral Therapy (CBT) and Motivational Interviewing (MI) techniques delivered through virtual platforms. Additionally, the intervention integrates Vernonia cinerea (White Flower Grass) tea as a traditional herbal therapy. Vernonia cinerea is recognized in the Thai National List of Essential Herbal Drugs for the ability to reduce nicotine cravings by altering taste perception, offering a low-cost, accessible alternative to conventional Nicotine Replacement Therapy (NRT).
Study Design and Workflow This is a cluster-randomized controlled trial (RCT) conducted at the community level to prevent data contamination.
Intervention Arm: Participants receive the comprehensive "New Normal" system including VHV home visits, Line App support, and integrated herbal/behavioral therapy.
Comparison Arm: Participants receive "Standard Care," which consists of traditional advice-giving at sub-district health promotion hospitals without the active digital follow-up or community-led task redistribution framework.
Statistical Analysis Plan Effectiveness will be analyzed using an Intention-to-Treat (ITT) approach to ensure results reflect real-world community implementation. Baseline characteristics will be compared using Chi-squared and Wilcoxon signed-rank tests. Success-defined as continuous abstinence at 6 months-will be verified through exhaled carbon monoxide (CO) monitoring using a piCO+ Smokerlyzer®. Multiple logistic regression will be used to identify significant predictors of success while controlling for confounding variables.
Summary of Changes The investigators have synthesized the technical protocols into a structured English format suitable for the "Detailed Description" field of ClinicalTrials.gov. This includes the theoretical framework (Andersen's Model), the innovative system components (Task Redistribution and Line App), and the use of Vernonia cinerea. Specific eligibility criteria and outcome measure definitions are mentioned only in context to avoid duplication with other specific modules.
