背景:在印度,每年约有135万人死于烟草使用。主要挑战,鉴于烟草使用的规模和有限的资源,正在大规模提供戒烟支持,低成本,并通过协调的跨系统努力;一个这样的例子是简短的建议干预。然而,缺乏高资质的工作人员来识别和咨询烟草使用者。任务转移是扩大这些干预措施的重要机会。
目标:LifeFirstSWASTH(通过停止烟草习惯来支持成年人的健康)计划改编自LifeFirst计划(由NarotamSekhsaria基金会开发,孟买,印度)-是一项戒烟计划,重点是孟买接受私人医疗保健的较低社会经济地位的患者。这个平行臂,整群随机对照试验调查LifeFirstSWASTH计划是否会增加低资源地区的戒烟率,孟买的高范围医疗保健环境。
方法:本研究将针对结核病特异性非政府组织(NGO),牙科诊所,和非政府组织实施一般健康计划,为社会经济地位较低的患者提供服务。干预手臂患者将收到一本小册子,解释烟草的有害影响。从业人员将接受培训,以提供简短的戒烟建议,感兴趣的患者将被转介到NarotamSekhsaria基金会顾问那里进行6个月的免费电话咨询。控制臂患者将收到相同的小册子,但不简短的建议或咨询。从业者将有一个定制的移动应用程序,以促进干预交付。从业者还可以通过WhatsApp访问对等网络。主要结果是戒烟30天点流行。患者和从业者的次要结果与干预实施有关。
结果:该研究于2020年6月获得资助。由于COVID-19大流行,这项研究经历了一些延误,和执业者招募于2023年11月开始。截至2024年7月,所有从业者都已被招募,从业人员招聘和培训已经完成。此外,36%(1687/4688)的患者已被招募。
结论:据推测,参加LifeFirstSWASTH计划的患者在6个月结束时更有可能连续30天戒烟或至少减少吸烟。人生第一的震惊,如果发现在戒烟结果和执行方面是有效的,有可能扩展到印度和其他低收入和中等收入国家的其他环境。该研究将在资源匮乏的环境中进行,并将覆盖许多患者,这将增加影响,如果扩大。它将使用任务转移和可以根据不同设置定制的应用程序,还可以实现可扩展性。研究结果将为从高收入国家到低收入和中等收入国家以及从高资源环境到低资源环境的循证干预措施建立文献。
背景:ClinicalTrials.govNCT05234983;https://clinicaltrials.gov/study/NCT05234983。
■DERR1-10.2196/57236。
BACKGROUND: About 1.35 million deaths annually are attributed to tobacco use in India. The main challenge, given the magnitude of tobacco use and limited resources, is delivering cessation support at scale, low cost, and through a coordinated cross-system effort; one such example being brief advice interventions. However, highly credentialed staff to identify and counsel tobacco users are scarce. Task-shifting is an important opportunity for scaling these interventions.
OBJECTIVE: The LifeFirst SWASTH (Supporting Wellbeing among Adults by Stopping Tobacco Habit) program-adapted from the LifeFirst program (developed by the Narotam Sekhsaria Foundation, Mumbai, India)-is a tobacco cessation program focusing on lower-socioeconomic status patients in Mumbai receiving private health care. This parallel-arm, cluster randomized controlled trial investigates whether the LifeFirst SWASTH program increases tobacco cessation rates in low-resource, high-reach health care settings in Mumbai.
METHODS: This study will target tuberculosis-specific nongovernmental organizations (NGOs), dental clinics, and NGOs implementing general health programs serving lower-socioeconomic status patients. Intervention arm patients will receive a pamphlet explaining tobacco\'s harmful effects. Practitioners will be trained to deliver brief cessation advice, and interested patients will be referred to a Narotam Sekhsaria Foundation counselor for free telephone counseling for 6 months. Control arm patients will receive the same pamphlet but not brief advice or counseling. Practitioners will have a customized mobile app to facilitate intervention delivery. Practitioners will also have access to a peer network through WhatsApp. The primary outcome is a 30-day point prevalence abstinence from tobacco. Secondary outcomes for patients and practitioners relate to intervention implementation.
RESULTS: The study was funded in June 2020. Due to the COVID-19 pandemic, the study experienced some delays, and practitioner recruitment commenced in November 2023. As of July 2024, all practitioners have been recruited, and practitioner recruitment and training are complete. Furthermore, 36% (1687/4688) of patients have been recruited.
CONCLUSIONS: It is hypothesized that those patients who participated in the LifeFirst SWASTH program will be more likely to have been abstinent from tobacco for 30 consecutive days by the end of 6 months or at least decreased their tobacco use. LifeFirst SWASTH, if found to be effective in terms of cessation outcomes and implementation, has the potential to be scaled to other settings in India and other low- and middle-income countries. The study will be conducted in low-resource settings and will reach many patients, which will increase the impact if scaled. It will use task-shifting and an app that can be tailored to different settings, also enabling scalability. Findings will build the literature for translating evidence-based interventions from high-income countries to low- and middle-income countries and from high- to low-resource settings.
BACKGROUND: ClinicalTrials.gov NCT05234983; https://clinicaltrials.gov/study/NCT05234983.
UNASSIGNED: DERR1-10.2196/57236.