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CTRI Number  CTRI/2024/02/062815 [Registered on: 19/02/2024] Trial Registered Prospectively
Last Modified On: 12/02/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Smoking cessation trend trial 
Scientific Title of Study   "Smoking cessation- A prospective longitudinal study of healthcare challenges at a tertiary care centre". 
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 Devi HJ 
Designation  Professor and Head of Department of Respiratory Medicine 
Affiliation  East Point College of Medical Sciences and Research Centre 
Address  Department of Respiratory Medicine, Room no 2. East Point Hospital Bidarahalli, Virgonagar post Bangalore.

Bangalore
KARNATAKA
560049
India 
Phone  9916195235  
Fax    
Email  dr.gayathridevi.epcms@eastpoint.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Abhishek Udaykumar 
Designation  Senior Resident Department of Respiratory Medicine 
Affiliation  East Point College of Medical Sciences and Research Centre 
Address  Department of Respiratory Medicine, Room no 2. East Point Hospital Bidarahalli, Virgonagar post Bangalore.

Bangalore
KARNATAKA
560049
India 
Phone  9845031890  
Fax    
Email  abhishek.epcms@eastpoint.ac.in  
 
Details of Contact Person
Public Query
 
Name  Abhishek Udaykumar 
Designation  Senior Resident Department of Respiratory Medicine 
Affiliation  East Point College of Medical Sciences and Research Centre 
Address  Department of Respiratory Medicine, Room no 2. East Point Hospital Bidarahalli, Virgonagar post Bangalore.

Bangalore
KARNATAKA
560049
India 
Phone  9845031890  
Fax    
Email  abhishek.epcms@eastpoint.ac.in  
 
Source of Monetary or Material Support  
East Point College of Medical sciences and research centre. 
 
Primary Sponsor  
Name  East Point College of Medical sciences and research centre. 
Address  Bidarahalli, Virgonagar post, Bangalore 560049 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Abhishek Udaykumar  East Point College of Medical sciences and research centre.  Department of Respiratory Medicine, Room no 2. East Point Hospital Bidarahalli, Virgonagar post Bangalore. 560049
Bangalore
KARNATAKA 
9845031890

abhishek.epcms@eastpoint.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee- East Point College Of Medical Sciences and Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: T652||Toxic effect of tobacco and nicotine,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Out-patients and in-patients who are current smokers, presenting to Respiratory
medicine department aged 21 years and above
2.Agreeing to participate  
 
ExclusionCriteria 
Details  1. Smokeless tobacco users
2. Patients on psychotropic drugs 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
smoking cessation- successful
smoking cessation- failure 
Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Trends of smoking in Bangalore  Baseline 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   23/02/2024 
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 Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [abhishek.epcms@eastpoint.ac.in].

  6. For how long will this data be available start date provided 01-01-2025 and end date provided 01-01-2075?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Need for the study: There is paucity of data regarding smoking cessation practices in the Indian literature. Our study aims at analysing the challenges in implementing smoking cessation strategies and development of skills that can be used by healthcare providers to facilitate health promoting behaviours among their patients. 
Aims & Objectives of the study 
• To assess knowledge, attitude & practices about smoking cessation among smokers visiting our institution. 
• To identify the challenges and the barriers in the implementation of smoking cessation programme among patients visiting our institution

 â€¢ Materials & Methods 
• Study design: A cross-sectional study, single center
 â€¢ Study setting: Patients presenting to Respiratory medicine department at East Point College of Medical Sciences & Research Center 
• Study duration:6 months
 â€¢ Period needed for collecting the data – 6 months
 â€¢ Period needed for tabulating the data – 1 month
 â€¢ Period needed for analysing the data – 1 month 
• Study population – 300 
Inclusion criteria
 - Out-patients and in-patients who are current smokers, presenting to Respiratory medicine department aged 21 years and above
 - Agreeing to participate 
 Exclusion criteria: Smokeless tobacco users 
 Patients on psychotropic drugs 
Study tools & Techniques: 
Questionnaire based Methodology: 
1. All patients with smoking history and providing informed consent will be recruited in the study.
 2. Demographic data shall be recorded.
 3. Detailed clinical history of the patient with the comorbidities will be collected.
 4. Questionnaire annexure attached (KAP) 
 5. Any abnormality on general physical examination and systemic examination will be noted 
 6. For those who are willing to quit, behaviour counselling will be done by psychiatry department and followed up for one month
 7. ECG for those willing to quit smoking and need nicotine replacement therapy
 8. The data will be collected in MS-EXCEL SHEET and will be subjected to statistical analysis.
 Biological material required: None 
Investigations: ECG
 Budget & Funding - None
 Sample Size: Sample size was estimated by using the proportion of subjects attempted to quit smoking in past was 89.4% from the study by Aiswaraya vijayakrishna et al. using the formula Sample Size = Z1-α /2 2 P (1-P) d 2 Z1-α /2 = is standard normal variate ( at 5% type 1 error (P<0.05) it is 1.96 and at 1% type1 error(P<0.01) it is 2.58). As in majority of studies P values are considered significant below 0.05 hence 1.96 is used in formula. P= Expected proportion in population based on previous studies or pilot studies d= Absolute error or precision P = 89.4% or 0.138 q = 10.6% or 0.8612 d = 5% or 0.05 Using the above values at 95% Confidence level a sample size is approximately 146. But we would like increase our sample size to 300. 
Statistical Methods Data will be entered into Microsoft excel data sheet and will be analyzed using SPSS 22 version software.
 Categorical data will be represented in the form of Frequencies and proportions. 
Chi-square will be used as test of significance. Continuous data will be represented as mean and standard deviation. Independent t test will be used as test of significance to identify the mean difference. P value <0.05 will be considered as statistically significant. 
 Conclusion 
Our study will allow for a better understanding of the factors for motivation and adherence to treatment of smoking cessation. Based on the results, smoking cessation interventions can be developed according to the socio-economic demographics of the region. Our study results will help us to implement strategies to motivate the patients to quit smoking at our center. 
Limitation - Single centred study
 
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