| CTRI Number |
CTRI/2024/11/076916 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
01/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Pre-post-test quasi-experimental single group design without control] |
| Study Design |
Other |
|
Public Title of Study
|
An AI Tool to Help People Quit Tobacco |
|
Scientific Title of Study
|
Implement and Evaluate CARE (Comprehensive AI-powered ConveRsational IntErface to Quit Tobacco) to improve cessation among tobacco users |
| Trial Acronym |
CARE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Monika Arora |
| Designation |
Vice President Research and Health Promotion |
| Affiliation |
Public Health Foundation of India |
| Address |
Public Health Foundation Of India
House No 60 4th Floor Lane 2 Part of Saidulajab Extension Near Saket Metro Station Gate No 2, New Delhi
South DELHI 110030 India |
| Phone |
9810056631 |
| Fax |
|
| Email |
monika.arora@phfi.org |
|
Details of Contact Person Scientific Query
|
| Name |
Prof Monika Arora |
| Designation |
Vice President Research and Health Promotion |
| Affiliation |
Public Health Foundation of India |
| Address |
Public Health Foundation Of India
House No 60 4th Floor Lane 2 Part of Saidulajab Extension Near Saket Metro Station Gate No 2, New Delhi
New Delhi DELHI 110030 India |
| Phone |
9810056631 |
| Fax |
|
| Email |
monika.arora@phfi.org |
|
Details of Contact Person Public Query
|
| Name |
Prof Monika Arora |
| Designation |
Vice President Research and Health Promotion |
| Affiliation |
Public Health Foundation of India |
| Address |
Public Health Foundation Of India
House No 60 4th Floor Lane 2 Part of Saidulajab Extension Near Saket Metro Station Gate No 2, New Delhi
New Delhi DELHI 110030 India |
| Phone |
9810056631 |
| Fax |
|
| Email |
monika.arora@phfi.org |
|
|
Source of Monetary or Material Support
|
| Indian Council Of Medical Research (ICMR) |
|
|
Primary Sponsor
|
| Name |
Public Health Foundation of India (PHFI) |
| Address |
Public Health Foundation Of India, House No. 60 4th Floor Lane 2, Part of Saidulajab Extension, Near Saket Metro Station Gate No. 2 New Delhi 110030 |
| Type of Sponsor |
Other [NGO] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Srabana Misra Bhagabaty |
Dr. B. Borooah Cancer Institute |
Gopinath Nagar, A K Azad Road, Guwahati-781016, Assam, India Kamrup ASSAM |
8876040232
srabana.misra@gmail.com |
| Dr Prabhat Chand |
NIMHANS |
National Institute of Mental Health and Neuro Sciences (NIMHANS),Hosur Road / Marigowda Road, (Lakkasandra, Wilson Garden)
Bangalore – 560029
Karnataka, India Bangalore KARNATAKA |
9845313617
prabhat@vknnimhans.in |
| Dr Sharmila Pimple |
Tata Memorial |
Homi Bhabha National Institute
Tata Memorial Centre
Mumbai 400012, India
Mumbai MAHARASHTRA |
02224154379
pimplesa@tmc.gov.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee II Tata Memorial Hospital |
Approved |
| Medical Ethics Committee |
Approved |
| NIMHANS Institutional Ethics Committee (IEC) |
Approved |
| PHFIs institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Tobacco Users availing services from Tobacco Cessation Services |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Tobacco Cessation |
Generative AI-based conversational interface to strengthen the existing cessation services offered through Tobacco Cessation Centres (TCCs)
Intervention details:The proposed Generative AI-based conversational interface through CARE will offer tailored cessation services including information on health risks, motivate users to quit, offer effective quitting strategies and reduce relapse through patient-supported networks. The key features will include, personalized quit plans, track quitting progress, milestones, behavioural support, reminders, and motivational messages
Duration: 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1) Aged 18 years and above
2) Individuals using any form of tobacco (smoking, smokeless or dual-use) and availing services at the TCC
3) Individuals using tobacco for the last 6 months
4) Individuals interested in quitting
5) Individual owns an Android/iOS Smartphone (with compatible versions eg android 11/+ or iOS 13/+)
6) Individuals have basic digital skills
7) Individual having permanent contact information
8) Participants with informed consent to participate in the study
|
|
| ExclusionCriteria |
| Details |
-Current enrollment in another digital tobacco cessation programme
-No Informed consent to participate
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcomes will be successful quit attempts, and increased intention to quit among tobacco users |
Successful Quit attempts: tobacco cessation 3 months ago, who reported ever tobacco use
Increased intention to quit current tobacco user thinking about quitting within next 3 months, 6 months or so |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcome will be increased acceptability, usability and user engagement with an AI-based conversational interface |
6 months |
|
|
Target Sample Size
|
Total Sample Size="426" Sample Size from India="426"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Rationale: Despite knowing the health benefits of tobacco cessation, there is a lack of AI-based cessation interventions, that address both smoking and smokeless tobacco (SLT) in India. Existing digital platforms often fail to comply with clinical cessation guidelines and underutilize features to facilitate active user engagement. Novelty: The proposed Generative AI-based conversational interface through CARE will offer tailored cessation services including information on health risks, motivate users to quit, offer effective quitting strategies and reduce relapse through patient-supported networks. The key features will include, personalized quit plans, track quitting progress, milestones, behavioural support, reminders, and motivational messages. The interface will cater to both smoking and SLT users, address rural and urban users’ needs, and provide services in regional languages. Objectives: To understand the facilitators and barriers tobacco users face in quitting and using digital interventions in the past. Based on this information, develop a Generative AI-based conversational interface to facilitate successful quit attempts. Methods: The study will employ a pre-post, quasi-experimental single-group design without control, using a mixed-methods approach. Participants will be current users of tobacco in any form seeking assistance from government tobacco cessation services. We will use the adapted version of the DISCOVER conceptual framework for the designing, development, implementation and evaluation of an AI-based conversational interface. |