Smoking CessationMUKTINCT03495622
Effectiveness of a Combined CHW and Text Messaging-based Tobacco Intervention in India
A study testing Motivational Interviewing/Text messaging in people with Smoking Cessation, run by University Hospitals Cleveland Medical Center at 2 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Motivational Interviewing/Text messaging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesIndia
- Study dates
- 1 Jan 2018to 1 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults between the ages of 18 and 70 years, who smoke cigarettes or bidis daily
- Individuals able and willing to give informed consent
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Effectiveness of a Combined CHW and Text Messaging-based Tobacco Intervention in India Project MUKTI: A Multi-Unit Kit for Tobacco Intervention
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.
Read the 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.
- Conditions
- Smoking Cessation
- Being tested
- Motivational Interviewing/Text messaging
- Keywords
- Text messaging, Community health worker, Smoking cessation, India, Cardiovascular mortality
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interviewing/Text messagingBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interviewing/Text messaging | Experimental | 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. Receives: Behavioral: Motivational Interviewing/Text messaging |
| Control | No intervention | All participants will receive brief verbal advice about the hazards of smoking and the benefits of smoking cessation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quit rate at the end of 1 year
Self-reported abstinence, biochemically verified, for the past 14 days at the end of 1 year from the start of the intervention.
Measured: 1 year
Secondary outcomes (1)
Relapse rate at the end of 1 year
The number of individuals who have relapsed into smoking after completing the intervention at the end of 1 year.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start1 Jan 2018
- Primary completion1 Aug 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Josephson, MS MD, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03495622
- Sponsor's protocol ID
- 12-17-29
- Acronym
- MUKTI
- Status last verified
- Aug 2019
- First submitted
- 26 Mar 2018
- Last updated
- 8 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Combined CHW and Text Messaging-based Tobacco Intervention in India Project MUKTI: A Multi-Unit Kit for Tobacco Intervention
- ClinicalTrials.gov ID
- NCT03495622
- Acronym / sponsor ID
- MUKTI / 12-17-29
- Conditions
- Smoking Cessation
- Keywords
- Text messaging, Community health worker, Smoking cessation, India, Cardiovascular mortality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 12 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing/Text messaging | Experimental | Behavioral: Motivational Interviewing/Text messagingHome 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. |
| Control | No intervention | –All participants will receive brief verbal advice about the hazards of smoking and the benefits of smoking cessation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults between the ages of 18 and 70 years, who smoke cigarettes or bidis daily
- Individuals able and willing to give informed consent
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational Interviewing/Text messagingThe 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 | Behavioural | Motivational Interviewing/Text messaging |
Primary outcome
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.
1 secondary outcome
Relapse rate at the end of 1 year
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing/Text messaging in people with Smoking Cessation, run by University Hospitals Cleveland Medical Center at 2 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quit rate at the end of 1 year (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2019.