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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

Expected outcomes: The primary outcomes will be successful quit attempts (tobacco cessation 3 months ago, who reported ever tobacco use), and increased intention to quit (current tobacco user thinking about quitting within next 3 months, 6 months or so) among tobacco users and the secondary outcome will be acceptability, usability and user engagement with the AI-based conversational interface.

 

 
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