Effectiveness of a Combined CHW and Text Messaging-based Tobacco Intervention in India
Condition: Smoking Cessation
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      The CHWs will be chosen from the study population based on a set of criteria through a formal
      selection panel after consulting with the local leaders and physicians. They will undergo a
      week of training for the screening process, an additional week for the intervention and
      finally a refresher course every 6 months.

      The text messages are selected from a pre-determined database of messages and the content of
      which changes based on the individual's stage of behavior change. The messages are delivered
      automatically every other day of the week and are controlled by the investigators in
      Cleveland, Ohio, USA.

      The control group, during their screening visit, will be informed of their problems, given a
      brief pamphlet and encouraged to seek physician help.

      The investigators hypothesize that a community health worker based intervention, utilizing
      motivational interviewing and health education, coupled with text messaging based support
      will lead to increased quit rates amongst participants who are daily smokers.

      At the end of one year, the self-reported abstinence of the participants in the intervention
      arm will be recorded and biochemically verified with a carbon monoxide breath analyzer test.
    

Intervention name(s): Motivational Interviewing/Text messaging
Intervention type(s): Behavioral
Intervention description(s): The intervention is a multi-component one that is tailored to the individual and will target smoking cessation. The CHW, after identifying the individual's stage of behavior change, will provide motivational interviewing and set up an automatic text messaging system with their mobile phones that are structured around a quit date chosen by the participant.
The CHW visits are pre-determined and she monitors the progress of the individual regularly. She may restart the process of determining the stage of behavior change for those who relapse or quit the intervention midway thereby reassigning them to the appropriate phase of the trial
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Cluster Randomized Controlled Trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Text messaging; Community health worker; Smoking cessation; India; Cardiovascular mortality