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CTRI Number  CTRI/2025/02/080610 [Registered on: 14/02/2025] Trial Registered Prospectively
Last Modified On: 12/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Preventive
Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of smoking cessation package on health related quality of life among Chronic Obstructive Pulmonary Disease patients attending Chest Medicine Out Patient Department of Bankura Sammilani Medical College and Hospital: A Quasi Experimental Study. 
Scientific Title of Study   Effect of smoking cessation package on health related quality of life among Chronic Obstructive Pulmonary Disease patients attending Bankura Sammilani Medical College and Hospital. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anirban Nandy 
Designation  Junior Resident 
Affiliation  Bankura Sammilani Medical College and Hospital 
Address  Department of Community Medicine, Natun Bhaban, BSMCH, College Rd., Kenduadihi, Bankura

Bankura
WEST BENGAL
722102
India 
Phone  9874932153  
Fax    
Email  nandyanirban@ymail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gautam Dhar 
Designation  Junior Resident 
Affiliation  Bankura Sammilani Medical College and Hospital 
Address  Department of Community Medicine, Natun Bhaban, BSMCH, College Rd., Kenduadihi, Bankura

Bankura
WEST BENGAL
722102
India 
Phone  9830467725  
Fax    
Email  drgoutamdhar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Gautam Dhar 
Designation  Junior Resident 
Affiliation  Bankura Sammilani Medical College and Hospital 
Address  Department of Community Medicine, Natun Bhaban, BSMCH, College Rd., Kenduadihi, Bankura

Bankura
WEST BENGAL
722102
India 
Phone  9830467725  
Fax    
Email  drgoutamdhar@gmail.com  
 
Source of Monetary or Material Support  
Bankura Sammilani Medical College and Hospital, Bankura, Kenduadihi, Bankura, West Bengal, India, Pin- 722102 
 
Primary Sponsor  
Name  Dr Anirban Nandy 
Address  Dept. of Community Medicine, Natun Bhaban, BSMCH, College Rd., Kenduadihi, Bankura- 722102 
Type of Sponsor  Other [Self] 
 
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 Anirban Nandy  Bankura Sammilani Medical College and Hospital, Bankurs  Chest Medicine Department, OPD Building, BSMCH, College Rd., Kenduadihi, Bankura- 722102
Bankura
WEST BENGAL 
9874932153

nandyanirban@ymail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Commitee, BSMCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Comparison group  Usual physician prescribed COPD treatment. 
Intervention  Smoking cessation package  Module based educational intervention along with Bupropion therapy 150 mg twice daily for 8 weeks along with usual physician prescribed COPD treatment. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. COPD patient who are diagnosed in past two years and are on treatment.
2. Smokers (smoking atleast 1 cigarette or bidi per day) for atleast last 5 years.
 
 
ExclusionCriteria 
Details  1. Users of other forms of smokeless tobacco.
2. History of asthma, asbestosis, silicosis, bronchiectasis or lung cancer.
3. Mentally retarded or severely ill to respond.
4. Patients’ with language and physical barrier.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
St. George’s Respiratory Score   Baseline and at 6 months  
 
Secondary Outcome  
Outcome  TimePoints 
Fagerström Test for Nicotine Dependence (FTND) Score   Baseline and at 6 months 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   25/02/2025 
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="1"
Months="0"
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 - NO
Brief Summary  

Objectives of Research: To assess the effect of smoking cessation package on health related quality of life among Chronic obstructive pulmonary disease (COPD) patients attending out-patient department of Bankura Sammilani Medical College and Hospital (BSMC&H), Bankura.


Background of Present Study:  Chronic obstructive pulmonary disease (COPD) is a major public health challenge in India with significant economic burden and healthcare utilization and contributes to patients’ daily life limitations. Health-related quality of life (HRQoL) reflects the health and disease-related aspects of QoL. Limited studies have examined this dimension in healthcare settings. We will explore the HRQoL among patients with COPD and the influence of smoking cessation package on them. We also tried to elicit other factors (enablers and constraints) influencing it.


Methodology: An analytical interventional study will be conducted among diagnosed COPD patients (on therapy and diagnosed within last 2 years) attending  out-patient department of BSMC, Bankura. After estimating sample size, 120 participants who attended OPD of Bankura Sammilani Medical College and Hospital, Bankura will be selected using systematic sampling satisfying the inclusion and exclusion criteria. The participants will be allocated into two groups. One group will undergo smoking cessation package as an intervention along with usual treatment for COPD, whereas the other group will only get the usual prescribed treatment for COPD. Data will be collected after getting consent from participants via interview and record review. Data will include socio-demographic information, barriers to quit smoking, HRQoL, dependence to smoking, and disease control status. The data will be collected before and after intervention (smoking cessation package) and compared. Collected data will be compiled in Microsoft Excel sheet and analyzed using appropriate statistical methods.


Expected outcome: Whether the magnitude of COPD symptoms leading to poor health related quality of life along with its different correlates may be improved by smoking cessation package is proposed to be explored. It may in turn help to adopt such measures for redressing such adverse circumstances, which may lead to better disease control status and in turn increase the health related quality of life.


 
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