跳至主要内容
临床试验/NCT05234983
NCT05234983进行中(未招募)不适用

LifeFirst Supporting Wellbeing Among Adults by Stopping Tobacco Habit

Harvard School of Public Health (HSPH)2 个研究点 分布在 1 个国家目标入组 4,820 人开始时间: 2023年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
4,820
试验地点
2
主要终点
Duration of abstinence from tobacco use

研究概览

简要总结

This study aims to promote tobacco cessation among adults in high-reach, low-resource community settings in Mumbai, India. Tobacco use is a major driver of cancer deaths and as of 2017, about 267 million individuals use smokeless and/or smoked tobacco in India. One of the WHO-endorsed evidence-based practices for tobacco cessation is brief advice interventions, which involve screening for tobacco use, advising patients to quit, and referring them to treatment. While these interventions often include medication for tobacco cessation in higher-income countries, such treatments can be an expensive and impractical solution in low- and middle-income countries. The team proposes a simplified brief advice intervention without the use of pharmacotherapy, to be implemented in community-based healthcare settings in Mumbai (TB treatment clinics, NGO-run health centers, and dental practices serving populations of lower-socioeconomic status). A task-shifting model will be used, moving program delivery responsibilities from clinicians to community health practitioners. The team also proposes to use a mobile app and a WhatsApp group to support ongoing training and engagement of practitioners.

The central questions are: Does a brief advice intervention adapted for use in low-resource settings in India through task-shifting and technology-based training support result in higher cessation rates than usual care? What are the key barriers to and facilitators of program implementation?

The study has three aims:

Aim 1: Adapt and pilot-test a tobacco cessation evidence-based program in three types of low-resource community-based healthcare settings in Mumbai.

Aim 2: The clinical trial itself involves assessing whether the adapted brief advice program results in increased quit rates among tobacco users (compared to usual care) in three types of healthcare settings. The hypothesis is that those assigned to the brief advice program will be more likely to have maintained tobacco cessation after 6 months compared to those who received usual care.

Aim 3: Evaluate the use of communication technologies, such as social media and apps, to support ongoing training and networking among practitioners who are implementing the intervention.

The long-term goal is to support adaptation and scale-up of tobacco control EBPs from high-resource to low-resource settings. Towards that goal, the overall objective is to develop a scalable, resource-appropriate brief advice EBP for use in India.

详细描述

Background and Significance:

About 1 million deaths are attributed to tobacco use in India each year. In 2017 there were roughly 267 million tobacco users including 199 million smokeless tobacco users, 100 million smokers, and 32 million dual users. Tobacco use is higher in rural versus urban populations (32% vs. 21%) and among men versus women (24% vs. 14%). In Mumbai, there are disparities in tobacco use based on education and occupation. Cessation is of interest to tobacco users in India. In a national survey, about 39% of smokers and 33% of smokeless tobacco users reported a quit attempt in the year preceding the survey. The challenge in India, given the magnitude of tobacco use and limited resources, is in delivering cessation supports at scale and with low cost. The problem of tobacco is multifaceted and widespread, with a lack of coordination among those engaged in tobacco cessation: community centers, NGOs and clinics. India is a signatory to the WHO Framework Convention on Tobacco Control (FCTC) and launched the National Tobacco Control Program in 2007, though the impact is limited by inconsistent enforcement across states and regions. Greater attention to and support for cessation of smokeless tobacco is also needed.

Low-resource settings require evidence-based cessation programs that can be delivered, sustained, and scaled-up at low cost. However, there are important barriers to scaling up evidence-based tobacco cessation in such settings. First, research syntheses, such as systematic reviews and meta-analyses mainly come from high-income settings and the interventions and strategies are difficult to implement in limited-resource settings such as India. Second, tobacco cessation EBPs typically include pharmacotherapy, a resource beyond the reach of most tobacco users and many healthcare systems in India. Also, most tobacco cessation EBPs focus solely on smoking, which is a mismatch for India given the high rates of smokeless, smoked, and dual tobacco use and the fact that the smokeless tobacco market in India is the world's largest. Third, EBPs are more likely to be scaled up in low- and middle-income countries (LMICs) if they are simple and inexpensive and can be used in alternative channels, such as NGOs or commercial operations, rather than relying entirely on government infrastructure and highly skilled personnel. Fourth, there is a gap in the literature regarding interventions to influence practice change among practitioners in LMICs. Together these gaps highlight a need to advance the science of adapting and implementing low-cost, scalable cessation EBPs for use in India and other LMICs.

One type of low-cost, scalable cessation support is brief advice interventions, or short engagement by providers to screen for tobacco use, offer cessation advice, and refer users to treatment resources. These interventions can typically be administered in 30 seconds to 2 minutes. Brief advice interventions are effective for both smoked and smokeless tobacco. Simple forms of these programs have been shown to have an impact of 1-3% increased cessation rates over no advice, which could translate to 7.8-23.4 million fewer tobacco users in India. Programs that have a higher level of counseling (as in this proposal) are expected to have greater impact. In a study of 19 tobacco cessation centers across India, tobacco users who received behavioral counseling demonstrated 12.5% cessation rates at six weeks post-intervention, only 5% less than those who received counseling and medication. If this level of impact was sustainable over the long-term, it could translate into 33 million fewer tobacco users. According to the 2016-2017 Global Adults Tobacco Survey (GATS) in India, only 48% of smokers and 31% of smokeless tobacco users were advised to quit by a provider, highlighting a potential role for brief advice interventions.

The use of diverse health professionals (rather than only highly credentialed individuals) is an important opportunity for brief advice interventions. India meets only 25% of the WHO benchmark for health care staffing, and available educational facilities are insufficient to grow the workforce to needed levels. To reach needed staffing levels, the number of physicians would need to increase by 151%, but the current annual growth rate is 10-14%. Task-shifting is a strategy that emphasizes moving tasks from highly credentialed workers to less credentialed (but more readily available) workers and can promote access to preventive services and health. The task-shifting model has been effectively used to deliver mental health EBPs in LMICs, showing that providers with little or no prior mental health training, and often little formal education, can deliver EBPs effectively with positive clinical outcomes. In a recent report, the Ministry of Family Health and Welfare, Government of India, recommended a task shifting approach suggesting that cessation programs be delivered by a range of health professionals, including health workers, community outreach workers, and other professionals. An important consideration for task-shifting models is the potential changes to practitioner training. For example, an EBP for autism spectrum disorder was adapted from the United Kingdom to sites in India and Pakistan. The use of non-specialists to deliver the program necessitated a change from a 2-day training for therapists to a 4-week training for non-specialists and new referral patterns and measures for non-specialist competencies.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
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

入选标准

  • Practitioner inclusion criteria:
  • targeted workers from targeted settings
  • sufficient language proficiency in English and/or Hindi to attend the training and take surveys
  • has not received prior in-depth LifeFirst training
  • can recruit 10-60 tobacco users in a six-month period
  • works in a setting in which brief advice can be added to the workflow
  • delivers care in Greater Mumbai and expects to do so for one year post-training
  • can secure institutional signoff to participate and utilize the program in practice
  • has an Android smartphone
  • Patient inclusion criteria:
  • user of smokeless and / or smoked tobacco
  • age 18 and over
  • attending the practice of an enrolled practitioner
  • has a mobile phone (required for data collection)
  • does not have another member of their household participating in the study
  • is not currently participating in any tobacco cessation program (such as through the National Quitline)

排除标准

  • Practitioner exclusion criteria:
  • does not work in one of the targeted settings
  • works in one of the targeted settings but is not a targeted worker
  • does not have sufficient language proficiency in English and/or Hindi to attend the training and take surveys
  • has received prior in-depth LifeFirst training
  • cannot recruit 36 tobacco users in a six-month period
  • does not work in a setting in which brief advice can be added to the workflow
  • does not deliver care in Greater Mumbai
  • delivers care in Greater Mumbai but does not expect to do so for one year post-training
  • cannot secure institutional signoff to participate and utilize the program in practice
  • does not have an Android smartphone
  • Patient exclusion criteria:
  • not a user of smokeless or smoked tobacco
  • under age 18
  • does not attend the practice of an enrolled practitioner
  • does not have a mobile phone
  • has another member of their household participating in the study
  • is currently participating in any tobacco cessation program (such as through the National Quitline)

结局指标

主要结局

Duration of abstinence from tobacco use

时间窗: 6-months post-recruitment

The team will adapt the Russell Standard, an established measure of smoking cessation, for use in our population, in which smokeless tobacco is an important form of tobacco use.

Self-reported abstinence from tobacco use

时间窗: 6-months post-recruitment

The team will ask patients a standard question, modified for smokeless tobacco use inclusion, "Have you used tobacco at all since (start date of abstinence period)?" For those who report that they have not used any form of tobacco at the 6-month follow-up, the team will conduct a biochemical verification.

Biochemical verification of tobacco cessation

时间窗: 6-months post-recruitment

Self-report regarding tobacco cessation may yield an over-reporting of abstinence, and the team will verify abstinence through testing of an established marker of tobacco use - cotinine, a primary metabolite of nicotine. For biochemical verification, the team will utilize a saliva-based test from Salimetrics, which uses a cotton stick that is chewed by the patient for two minutes, placed into a tube, and then transported to a laboratory for analysis using Enzyme-Linked Immuno Sorbent Assay. Following the Society for Nicotine and Tobacco Research guidelines, the cutoff will be 15 ng/mL, but the team will also conduct sensitivity analyses at 12 and 20 ng/mL.

次要结局

  • Perceptions of the technology-based supports(6-months post-recruitment)
  • Quit attempts(6-months post-recruitment)
  • Reduction in tobacco use(6-months post-recruitment)
  • Implementation outcomes(6-months post-recruitment)
  • Psychosocial antecedents(6-months post-recruitment)
  • User engagement(6-months post-recruitment)

研究者

发起方
Harvard School of Public Health (HSPH)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Shoba Ramanadhan

Assistant Professor of Social and Behavioral Sciences

Harvard School of Public Health (HSPH)

研究点 (2)

Loading locations...

相似试验