| 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
|
|
|
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
|
|
|
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. |