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A 12- week clinical study to check the acceptance and user friendly use of a smartphone application designed for tobacco cessation, in male and female subjects equal to or more than 18 years of age who are regular smokers or smokeless tobacco users

A 12- week open label clinical study to evaluate the acceptability and perceived Usability of a smartphone application designed for tobacco cessation, in male and female subjects = 18 years of age who are regular smokers or smokeless tobacco users. - NIL

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/07/071346
Enrollment
12
Registered
2024-07-25
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Z789- Other specified health status

Interventions

Intervention1: smartphone application: This study involves use of smartphone application for survey on tobacco cessation. All the subject data will be recorded in the source document, CRF and feedbac

Sponsors

Impact Health Tech Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male and female subjects in the age group = 18 years 2. Subject using tobacco more than 3 times a day, at least 6 days a week, and using it for at least from 1 full year without a break 3. Subject using any form of tobacco smoking (cigarettes/ bidis/cigar, hukkah etc) and smokeless tobacco (Mawa, Gutka, Mishri, Jarda etc) 4. Subject willing to quit tobacco smoking/smokeless tobacco use 5. Subjects who are educated and who are able to read, type and understand instructions in English language 6. Can read and understand instructions and information given via poster, videos, chatbot and other sections in smartphone application, and be able to give their feedback on the application 7. Subject having a smartphone Android - OS Version 9.0 or above, or iOS – OS Version 11.0 or above 8. Subject/ Legally Acceptable Representative (LAR) of the subject willing to sign the informed consent form 9. Interested in learning, knowing, and following tips to quit tobacco smoking and/or smokeless tobacco use 10. Not participating in any other tobacco cessation interventions study

Exclusion criteria

Exclusion criteria: 1. Subject under the age of 18 years and who does not use tobacco as per the give inclusion criteria number 2 and 3 2. Subject had cognitive impairment or a substance use disorder (e.g., alcohol, cannabis, and opioid) 3. Subject is a pregnant woman/lactating mother 4. Individuals with mental health complications that have been managed for less than 6- months 5. Hearing and/or vision disabilities in receiving intervention assessment such as videos or podcasts 6. Inability to read, type, speak and understand instructions and concepts in English language 7. Using any other tobacco cessation interventions (including apps or our other intervention studies) 8. Subject who are not willing to spend time or follow the protocol procedure 9. Subject who is illiterate

Design outcomes

Primary

MeasureTime frame
1. To evaluate the smartphone application functionality specifically designed to reduce the prevalence of tobacco consumption, by assessing its usability during the 12-week study programTimepoint: Feasibility of ease of use of the smartphone application for tobacco cessation over a 12 weeks duration using a questionnaire

Secondary

MeasureTime frame
Not ApplicableTimepoint: Not Applicable

Countries

India

Contacts

Public ContactDr Ruchi Joshi

CRO-Jehangir Clinical Development Centre

neelambari@jcdc.co.in9823783443

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026