| CTRI Number |
CTRI/2023/05/052863 [Registered on: 18/05/2023] Trial Registered Prospectively |
| Last Modified On: |
04/12/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Other (Specify) [Mobile application based digital therapeutic] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
QuitSure Smoking Cessation Mobile App Effectiveness Trial. |
|
Scientific Title of Study
|
Randomized Controlled Trial for Smartphone-based Smoking Cessation Program – QuitSure |
|
Secondary IDs if Any
|
| Secondary ID |
Registry |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rohit Srivastava |
| Address |
NanoBios Lab Dept of Biosciences and Bioengineering IIT Bombay
NanoBios Lab Dept of Biosciences and Bioengineering IIT Bombay
Mumbai
MAHARASHTRA
400076
India |
| Phone |
9867980408 |
| Fax |
|
| Email |
rsrivasta@iitb.ac.in |
|
Details Contact Person
Scientific Query
|
| Name |
Dr Arnab Ghosh |
| Address |
NanoBios Lab Dept of Biosciences and Bioengineering IIT Bombay
NanoBios Lab Dept of Biosciences and Bioengineering IIT Bombay
Mumbai
MAHARASHTRA
400076
India |
| Phone |
9168219911 |
| Fax |
|
| Email |
drarnab.edu@gmail.com |
|
Details Contact Person
Public Query
|
| Name |
Dr Aniket Kundu |
| Address |
NanoBios Lab Dept of Biosciences and Bioengineering IIT Bombay
NanoBios Lab Dept of Biosciences and Bioengineering IIT Bombay
Mumbai
MAHARASHTRA
400076
India |
| Phone |
8454937539 |
| Fax |
|
| Email |
kunduaniket00@gmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Rapidkart Online Private Limited, a company registered under the laws of India, with
its registered address at Bajaj Bhavan, Cabin No 1, 2nd Floor, Jamnalal; Bajaj Marg, 226
Nariman Point, Mumbai – 400 021, and registration number; U5210CMH2014PTC256711. |
|
|
Primary Sponsor
|
| Name |
IIT BOMBAY |
| Address |
Dr Rohit Srivastava NanoBios Lab Dept of Biosciences and Bioengineering IIT Bombay
PIN 400076
|
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| MS Rapidkart Online Private Limited |
Bajaj Bhavan Cabin No 1 2nd Floor Jamnalal Bajaj Marg 226 Nariman Point Mumbai 400021
Registration Number U5210CMH2014PTC256711
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
| Lt Col SRIKRISHNA PRASAD PANDA |
ARMED FORCES MEDICAL COLLEGE, PUNE |
SHOLAPUR ROAD, WANOWRIE, PUNE-411040
Pune
|
7972280934
drsppanda@gmail.com |
| Dr Ananya Bhowmik |
Code Wellness Centre |
321A Prince Anwar Shah Rd, beside Metropolis Lab Madar Tala Colony Lake Gardens Kolkata West Bengal
PIN 700095
Kolkata
|
8100517024
ananya50@gmail.com |
| Dr Sanjiv Kale |
DYPUSM Navi Mumbai |
Vasantdada Patil Marg Sector 4 CBD Belapur Navi Mumbai Maharashtra 400614
Mumbai (Suburban)
|
9820547252
sanjivkale58@gmail.com |
| Prof Rohit Srivastava |
Indian Institute of Technology Bombay |
Dept of Biosciences and Bioengineering, Indian Institute of Technology, Bombay
Mumbai
|
9867980408
rsrivasta@iitb.ac.in |
| Dr JONATHAN L |
KSHEMA NITTE |
6th Floor, University Enclave, Medical Sciences Complex, Deralakatte, Mangaluru, Karnataka 575018
Bangalore
|
9008127372
jontysaba@gmail.com |
| DR NILADRI DAS |
Nilratan Sarkar Medical College and Hospital, |
Nilratan Sarkar Medical College and Hospital Kolkata
Kolkata
|
7291906745
dr.niladridas90@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| DY Patil Deemed to be University School of Medicine |
Approved |
| IIT Bombay-Institute Ethics Committee |
Approved |
| Institutional Ethics Committee Nilratan Sircar Medical college & Hospital |
Approved |
| Institutional_Ethics_Committee_Nilratan_Sircar_Medical_college_Hospital |
Approved |
| KHSEMA Nitte Demeed to be university |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Tobacco Smoking addiction
ICD-10-CM F17 (Nicotine dependence)
ICD-10-CM Z72.0 (Tobacco use)
ICD-10-CM Z87.891 (Personal history of nicotine dependence)
|
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Brief advice to quit smoking. |
For Control Group Name: Brief advice to quit smoking Duration: 7 days Mode of administration: Digital media/ phone/online/in-person Condition/Disease Targeted: Nicotine dependence/ Tobacco use/ Personal history of nicotine dependence Test for evaluation: Biochemical confirmation for nicotine use with Salivary Cotinine (non-invasive) test at the time of enrollment Self-declaration by the participant in the control arm who has been given Brief advice to quit smoking, about their abstinence from smoking or tobacco use which ascertains their quitting status by biochemical verification with- Salivary Cotinine (non-invasive) test after 1, 3, and 6 months of completion of the app usage |
| Intervention |
QuitSure Mobile Application
|
For Intervention group
Name: QuitSure Mobile App usage for 7 days
Duration: 7 days
Mode of administration: Digital media/ phone/online/
Condition/Disease Targeted: Nicotine dependence/ Tobacco use/ Personal history of nicotine dependence
Test for evaluation: Biochemical confirmation for nicotine use with Salivary Cotinine (non-invasive) test at the time of enrollment
Self-declaration by the user of the app Quitsure, about their abstinence from smoking or tobacco use which ascertains their quitting status by biochemical verification with- Salivary Cotinine (non-invasive) test after 1, 3, and 6 months of completion of the app usage. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
(i) Smokes at least 1 cigarette per day on average and has smoked at least 100
cigarettes till date.
(ii) Agrees to participate in a smoking cessation treatment program with written
informed consent
(iii) Must be an adult over 18 years of age
(iv) Are, at minimum, proficient in the written and spoken English Language
(v) Must be an everyday smoker: Should currently smoke 01 (one) or more
cigarettes per day on an average (indicating sufficient dependence on nicotine)
and have smoked at least 100 cigarettes (indicating sufficient exposure of the
body to nicotine) on a regular basis.
(vi) Have daily access to an Android or iOS smartphone.
(vii) Salivary cotinine test positive on the first visit.
(viii) Can use a smartphone without difficulty.
(ix) Rinsed mouth thoroughly with water 10 minutes before sample is collected.
(x) Inclusion criteria for controls: Age and gender matched controls. |
|
| ExclusionCriteria |
| Details |
(i) Has already quit smoking and is currently not smoking.
(ii) If a doctor has advised the participant not to quit cold-turkey.
(iii) History of severe mental illness/ psychiatric illness or under current treatment
for psychiatric illness such as schizophrenia or other primary psychotic
disorders, BPAD, catatonia, OCD, dissociative disorders, eating disorders,
personality disorders.
(iv) Unable to attend follow-up clinic visits during the study period.
(v) Started taking a smoking cessation medication within 1 year before the
registration.
(vi) Planned to use any smoking cessation aids and/or to participate in any kind of
smoking-cessation activities (not limited to smoking cessation therapy) outside
of the trial.
(vii) Consumed a major meal within 60 minutes before the test.
(viii) Consumed alcohol within 12 hours before the test.
(ix) Consumed foods like broccoli, cabbage, mustard, garlic, radishes, almonds and
horseradish within 12 hours.
(x) Persons working with metal, the related occupations include electroplaters and
people who refine precious metals.
(xi) Tobacco workers.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| cessation of smoking. |
after 4 weeks and 24 weeks. |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Any form of nicotine and / or smokeless tobacco consumption. |
06 months and 12 months. |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
01/06/2023 |
| Date of First Enrollment (Global) |
No Date Specified |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
Brief Summary
Modification(s)
|
| The proposed topic of research: Randomized Controlled Trial for Smartphone-based Smoking Cessation Program – QuitSure The objective of the proposed research: A. To assess the impact of the QuitSure program on short-term and long-term smoking cessation. B. To determine the level of engagement with the QuitSure smartphone app and C. To assess the feasibility of the QuitSure program. Background of the present study: Tobacco smoking remains one of the leading causes of preventable death worldwide. The most effective tobacco cessation programs require personalized human intervention combined with costly pharmaceutical supplementation, making them unaffordable and/or inaccessible to most tobacco users. Thus, digital interventions, delivered through smartphones, offer a promising alternative to these traditional methods. We would like to understand whether text and video-based content, delivered via a smartphone application, with minimal to zero human intervention, can be used to reverse the psychological dependence on nicotine (via smoking or vaping) at scale. To answer this, we propose to conduct a randomized controlled trial of the QuitSure smartphone-app-based tobacco cessation program. Methodology: A two-arm, single-blinded, randomized controlled trial design on adult everyday smokers (at least 1 cigarette per day on average and have smoked at least 100 cigarettes). Eligible participants will be randomly assigned to either do the QuitSure program [the IG] or will simply be given brief advice to quit smoking [the CG]. Both point prevalence (PPA) abstinence and prolonged abstinence (PA) outcomes will be recorded via self-reporting via phone, online, or in-person at the 7-day, 30-day, 3-month, and 6-month time points post the quit date (in the case of the IG) or post the quit date defined in by the CG. At the 30-day and 6- month time points we will also biochemically verify self-reported data by testing saliva cotinine (non-invasive test) in the participants. Expected outcome: We expect the Quitsure program to be efficacious and feasible for both short-term and long-term cessation of smoking | |
