| CTRI Number |
CTRI/2024/12/078597 [Registered on: 26/12/2024] Trial Registered Prospectively |
| Last Modified On: |
18/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening
Behavioral
Other (Specify) [Application based intervention for smoking cessation ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Smoke-Free: A Mobile App Intervention to Help People Quit Smoking |
|
Scientific Title of Study
|
Development and Evaluation of a comprehensive application based intervention for smoking cessation: a prospective interventional study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gayathri J |
| Designation |
Post graduate |
| Affiliation |
Saveetha Medical college and hospital |
| Address |
department of psychiatry,
Saveetha medical college and hospital, psychiatry out patient clinic saveetha medical college and hospital, Chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
9489820459 |
| Fax |
|
| Email |
gayathri.jaganathan3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Iniyan S |
| Designation |
Professor |
| Affiliation |
Saveetha Medical college and hospital |
| Address |
department of psychiatry,
Saveetha medical college and hospital, Chennai , Tamil Nadu, india
Chennai
TAMIL NADU
602105
India |
| Phone |
9894514942 |
| Fax |
|
| Email |
Iniyanmbbs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gayathri J |
| Designation |
Post graduate |
| Affiliation |
Saveetha Medical college and hospital |
| Address |
psychiatric out patient clinic , department of psychiatry,
Saveetha medical college and hospital, Chennai , Tamil Nadu
Chennai
TAMIL NADU
602105
India |
| Phone |
9489820459 |
| Fax |
|
| Email |
gayathri.jaganathan3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Gayathri j / post graduate in department of psychiatry, saveetha medical college and hospitals, Chennai , Tamil Nadu, PIN code 602105. |
|
|
Primary Sponsor
|
| Name |
Saveetha medical college |
| Address |
SAVEETHA MEDICAL COLLEGE AND HOSPITALS, saveetha nagar, THANDALAM , Chennai Bengaluru, NH48, CHENNAI-602105, TAMIL NADU, INDIA |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gayathri j |
SAVEETHA medical college |
Ic 1opd, ic 2 opd, ic3 opd, ic4 opd, psychiatric out patient clinic , department of psychiatry, SAVEETHA medical college and hospital , Thandalam, Chennai 602105
Chennai
TAMIL NADU |
9489820459
gayathri.jaganathan3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha medical college and hospital ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F172||Nicotine dependence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comprehensive Application-Based Intervention for Smoking Cessation |
Personalized Behavioral Support, Daily Tracking, Craving Management Tools, Motivational Content, Educational Resources, duration of 3 months |
| Comparator Agent |
Standard Smoking Cessation Counseling with 5A and 5R Methods |
Psychological Intervention:
The control group will receive standard smoking cessation counseling based on the 5A (Ask, Advise, Assess, Assist, Arrange) and 5R (Relevance, Risks, Rewards, Roadblocks, Repetition) framework. This is a well-established, evidence-based method used to encourage smokers to quit.
5A Method:
1. Ask: Systematically identify all tobacco users at every visit.
2. Advise: Strongly urge all tobacco users to quit.
3. Assess: Determine the patient’s willingness to make a quit attempt.
4. Assist: Provide practical counseling and pharmacotherapy to help in the quit attempt.
5. Arrange: Schedule follow-up contact to assess and support progress in quitting.
5R Method (for those unwilling to quit immediately):
1. Relevance: Discuss how quitting is relevant to the patient’s life and health.
2. Risks: Outline the risks of continuing smoking (short-term and long-term health consequences).
3. Rewards: Emphasize the benefits of quitting (improved health, financial savings, better quality of life).
4. Roadblocks: Identify barriers to quitting (e.g., fear of withdrawal, social triggers) and address them.
5. Repetition: Continue to reinforce the quitting message and repeat interventions at each visit.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults aged 18-65 years.
2. Current smokers (≥1 cigarette daily for 6 months).
3. Access to a smartphone/tablet for app use.
4. Able to read/understand app language.
5. Willing to provide informed consent |
|
| ExclusionCriteria |
| Details |
1. Severe medical/psychiatric conditions.
2. Dependence on substances other than nicotine.
3. Enrolled in other cessation programs or using cessation medications.
4. Pregnant or breastfeeding.
5. No access to a compatible device.
6. Unwilling to commit to follow-up. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The proportion of participants who achieve sustained smoking abstinence at specific follow-up points |
The proportion of participants who achieve sustained smoking abstinence at specific follow-up points, baseline, 4 weeks, 8 weeks, 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Breathing Exercises
 5D Cravings Management
Awareness about Passive Smoking
Ill Effects Education
Fagerstrom Questionnaire
Effective Daily Craving Management Stress Coping Techniques
Individualized Video Support
Bridge Between Patients & Healthcare Providers |
The proportion of participants who achieve sustained smoking abstinence at specific follow-up points at baseline 3weeks 8 weeks 12weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
30/12/2024 |
| 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="0"
Months="6"
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
|
Smoking cessation remains a critical public health concern, necessitating effective interventions. This prospective interventional study introduces an app-based smoking cessation program designed to aid smokers in managing daily cravings, coping with withdrawal stress, enhancing motivation, and bridging the gap between patients and healthcare providers. The intervention includes daily craving management strategies, stress coping techniques, motivational enhancement through personalized trackers, and curated videos based on individual cravings and cigarette usage levels. The study aims to evaluate the program’s efficacy through pre and post-usage tests, comparing various parameters related to smoking behavior, cravings, stress levels, and overall cessation success. |