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Effectiveness of a Combined CHW and Text Messaging-based Tobacco Intervention in India (MUKTI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03495622
Recruitment Status : Completed
First Posted : April 12, 2018
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
Richard Josephson, MS MD, University Hospitals Cleveland Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: Motivational Interviewing/Text messaging Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cluster Randomized Controlled Trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of a Combined CHW and Text Messaging-based Tobacco Intervention in India Project MUKTI: A Multi-Unit Kit for Tobacco Intervention
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : August 1, 2019
Actual Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: Motivational Interviewing/Text messaging

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


No Intervention: Control
All participants will receive brief verbal advice about the hazards of smoking and the benefits of smoking cessation.



Primary Outcome Measures :
  1. Quit rate at the end of 1 year [ Time Frame: 1 year ]
    Self-reported abstinence, biochemically verified, for the past 14 days at the end of 1 year from the start of the intervention.


Secondary Outcome Measures :
  1. Relapse rate at the end of 1 year [ Time Frame: 1 year ]
    The number of individuals who have relapsed into smoking after completing the intervention at the end of 1 year.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adults between the ages of 18 and 70 years, who smoke cigarettes or bidis daily
  2. Individuals able and willing to give informed consent

Exclusion Criteria:

  1. Individuals who are bed-bound because of acute illness or have a chronic condition that makes them bed-bound.
  2. Individuals who refuse consent
  3. 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.
  4. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03495622


Locations
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India
SEHAT
Jabalpur, Madhya Pradesh, India
SEHAT
Dalkhola, West Bengal, India, 733201
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
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Responsible Party: 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
ClinicalTrials.gov Identifier: NCT03495622    
Other Study ID Numbers: 12-17-29
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Richard Josephson, MS MD, University Hospitals Cleveland Medical Center:
Text messaging
Community health worker
Smoking cessation
India
Cardiovascular mortality