| CTRI Number |
CTRI/2025/08/092412 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
How Chronic Obstructive Pulmonary Disease Affects Patients Life |
|
Scientific Title of Study
|
Assessment Of Factors Associated With Poor Quality Of Life Of Chronic Obstructive Pulmonary Disease Patients - A Cross-Sectional 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 |
Albin Manoj |
| Designation |
PG Student |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice NGSM Institute of Pharmaceutical Sciences Paneer Derlakatte Mangalore
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
85473399405 |
| Fax |
|
| Email |
albinmanoj72@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Barma Naga Raju |
| Designation |
Assistant Professor |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice NGSM Institute of Pharmaceutical Sciences Paneer Derlakatte Mangalore
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
9949617946 |
| Fax |
|
| Email |
barmanagaraju08@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Barma Naga Raju |
| Designation |
Assistant Professor |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice NGSM Institute of Pharmaceutical Sciences Paneer Derlakatte Mangalore
KARNATAKA 575018 India |
| Phone |
9949617946 |
| Fax |
|
| Email |
barmanagaraju08@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pharmacy Practice NGSM Institute of Pharmaceutical Sciences, Paneer, Derlakatte, Mangalore, Karnataka, 575018 |
| Justice KS Hegde Charitable Hospital, Derlakatte, Mangalore, Karnataka, 575018 |
|
|
Primary Sponsor
|
| Name |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice NGSM Institute of Pharmaceutical Sciences, Paneer, Derlakatte, Mangalore, Karnataka, 575018 |
| Type of Sponsor |
Other [Academic Institute] |
|
|
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 Chandramouli M T |
Justice KS Hegde Charitable Hospital |
Department of Pulmonary Medicine Dakshina Kannada KARNATAKA |
9632551141
mouli.aims@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NGSM Institute of Pharmaceutical Sciences Institutional Ethics Committee (NGSMIPS-IEC) |
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 |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients of 18 years and above
Diagnosed with COPD with or without comorbidities
Patients willing to give consent
|
|
| ExclusionCriteria |
| Details |
Patient with severe illness
Patient who can’t communicate properly
Psychiatric, cognitive, and terminal illness patients
Pregnant and lactating women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| •This study will give the insights about domains which are affecting the QoL of the chronic obstructive pulmonary disease patients |
8 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| •The current study will highlight the factors affecting the poor QoL in Chronic obstructive pulmonary disease patients which helps the physicians in management of the COPD. |
8 months |
|
|
Target Sample Size
|
Total Sample Size="110" Sample Size from India="110"
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)
|
16/08/2025 |
| 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="0" Months="8" 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
|
INTRODUCTION COPD is a common avoidable, and treatable respiratory disease is characterized by persistent breathing difficulties and airflow limitation, due to abnormal inflammatory response of the airways to noxious particles or gases. According to data from India, the prevalence of COPD rises with age and reaches an exponential level beyond the age of thirty. The prognostic factors associated with health-related quality of life (HrQoL) are smoking, obesity, diseases such as depression, older age, comorbidity which may aggregate the condition of COPD. OBJECTIVES OF STUDY To assess the health-related quality of life among the chronic obstructive pulmonary disease patients. To assess the factors associated with poor health-related quality of life of chronic obstructive pulmonary disease patient. JUSTIFICATION OF THE STUDY There are various factors which affects the HrQoL of the COPD patients which causes economic burden to patients and healthcare system. Assessment of the HrQoL of the COPD patients is important because it helps in planning the treatment regimen and identify the progression of the disease. Identification these risk factors which are associated with poor HrQoL of the COPD patients helps in better planning the treatment and education the patients. METHODOLOGY It is an observational cross-sectional study will be conducted at the Department of Pulmonary Medicine, Justice K S Hedge Charitable Hospitable. Patients of aged 18 years and above with confirmed diagnosis of Chronic Obstructive Pulmonary disease and willing to participate in the study will be included. A structured data collection form will be used to collect the sociodemographic and clinical details of the patients. St. George’s Respiratory Questionnaire for COPD will be used assess the HrQoL of COPD patients. STATISTICAL ANALYSIS Qualitative data will be expressed in frequency and percentage Quantitative variable will be expressed as mean ±SD or median (Q1, Q3). Multiple linear regression will be used to find the factors associated to QoL of COPD patient. SPSS software version 2.0 will be used for statistical analysis. P value <0.05 will be consider statistically significant. OUTCOME MEASURES This study gives the insights about domains which are affecting the HrQoL of the chronic obstructive pulmonary disease patients. The current study highlights the factors affecting the HrQoL in Chronic obstructive pulmonary disease patients which helps the physicians in management of the COPD. |