Effectiveness of a Combined CHW and Text Messaging-based Tobacco Intervention in India Project MUKTI: A Multi-Unit Kit for Tobacco Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Quit rate at the end of 1 year
研究概览
简要总结
The study is a multi-center 1-year community-based cluster randomized controlled trial to assess the role of a combined community health worker and mobile health intervention in controlling one of the most common cardiovascular risk factors, tobacco use. Participants will include 560 adults, 18-70 years of age, from the urban communities of Dalkhola, West Bengal, and Jabalpur, Madhya Pradesh, India. The hypothesis of the study is that this combined approach can result in increased quit rate among tobacco users.
详细描述
Smoking tobacco is a major contributor to the global cardiovascular disease burden. India bears a huge part of this burden and it is estimated that nearly a quarter million individuals aged >15 years consume tobacco in India. Moreover, about 70% of tobacco deaths are reported to be in the age range of 30-69 years.
Motivational interviewing (MI) is an innovative manner of communication which puts the focus on the patient and strengthens their motivation for behavior change without overt confrontation or persuasion. MI delivered by community health workers (CHW) is part of the strategy planned by the investigators.
In order to deliver personalized assistance and increase penetration of the required intervention into different parts of the country, text messaging is a promising strategy in low and middle-income countries but there is no data regarding its application for tobacco use in India.
The investigators plan to screen 560 individuals between the age of 18 and 70 years for smoking from 16 randomly selected clusters in the economically backward urban towns of Dalkhola (West Bengal) and Jabalpur (Madhya Pradesh). The screening will be done using house to house visits by CHWs who will administer a questionnaire based on the WHO STEPS survey. An individual identified as a chronic tobacco user irrespective of his/her stage of behavior change will be eligible for further participation in the study and assigned to the appropriate intervention arm. Clusters will be randomized to either receive the combined intervention or usual care.
Apart from screening and recruitment, CHWs will be responsible for differentiating individuals between being pre-contemplative vs contemplative. Based on their readiness to quit, participants will receive a structured intervention which involves motivational interviewing delivered by the CHW in their homes and weekly support provided through regular mobile text messages.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults between the ages of 18 and 70 years, who smoke cigarettes or bidis daily
- •Individuals able and willing to give informed consent
排除标准
- •Individuals who are bed-bound because of acute illness or have a chronic condition that makes them bed-bound.
- •Individuals who refuse consent
- •Individuals who do not reside in the community and are only visiting, therefore being unlikely to be available for continuous follow up. Individuals who have stayed less than 6 months in the study area, or whose name is not on the voter list of the area will be excluded.
- •Individuals who are not able to participate in the intervention due to significant disabilities, such as blindness, deafness or the intellectually disabled. This determination is at the discretion of the community health worker.
研究组 & 干预措施
Motivational Interviewing/Text messaging
Home visits by community health worker to deliver motivational interviewing and set up a structured text messaging strategy designed around a pre-determined quit date for smoking cessation.
干预措施: Motivational Interviewing/Text messaging (Behavioral)
Control
All participants will receive brief verbal advice about the hazards of smoking and the benefits of smoking cessation.
结局指标
主要结局
Quit rate at the end of 1 year
时间窗: 1 year
Self-reported abstinence, biochemically verified, for the past 14 days at the end of 1 year from the start of the intervention.
次要结局
- Relapse rate at the end of 1 year(1 year)
研究者
Richard Josephson, MS MD
Professor of Medicine Case Western Reserve University School of Medicine/ Director Cardiovascular and Pulmonary Rehabilitation program University Hospitals Cleveland Medical Center, Division of Cardiovascular Medicine
University Hospitals Cleveland Medical Center