Smoking Cessation Clinical Trial
— MUKTIOfficial title:
Effectiveness of a Combined CHW and Text Messaging-based Tobacco Intervention in India Project MUKTI: A Multi-Unit Kit for Tobacco Intervention
NCT number | NCT03495622 |
Other study ID # | 12-17-29 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 1, 2018 |
Est. completion date | August 1, 2019 |
Verified date | August 2019 |
Source | University Hospitals Cleveland Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 300 |
Est. completion date | August 1, 2019 |
Est. primary completion date | August 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
India | SEHAT | Dalkhola | West Bengal |
India | SEHAT | Jabalpur | Madhya Pradesh |
Lead Sponsor | Collaborator |
---|---|
University Hospitals Cleveland Medical Center |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 1 year | |
Secondary | 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. | 1 year |
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