Chronic Obstructive Pulmonary Disease, Quality of Life, COPD Assessment Test, Nepal, Dyspnea, Spirometry
Conditions: COPD (Chronic Obstructive Pulmonary Disease), Quality of Life
Sponsor: Institute of medicine, Maharagjung medical campus

COVER PAGE 
Official Study Title: 
Quality of Life Among People Living With Chronic Obstructive Pulmonary Disease Visiting the 
Spirometry Center of Tribhuvan University Teaching Hospital, Kathmandu, Nepal 
NCT Number: 
Unavailable 
Unique Protocol ID: 
353 (6-11) E2 077/078 
Sponsor: 
Institute of Medicine, Maharajgunj Medical Campus 
Principal Investigator: 
Abhishek Kumar Shah 
Principal Investigator 
Institute of Medicine, Maharajgunj Medical Campus 
Document Type: 
Study Protocol, Statistical Analysis Plan, and Informed Consent Form 
Document Date: 
November 29, 2025 
Version: 
Version 1.0 
 
 
 
 
 
 
 
 
 
 
 

Team Members:  
Abhishek Kumar Shah, MBBS (PI), Institute of Medicine, Kathmandu, Nepal 
Dr. Narayan Prasad Neupane, MBBS, Institute of Medicine, Kathmandu,Nepal 
Nishant Neupane, MBBS, Institute of Medicine, Kathmandu,Nepal 
Dr. Bishal Bashyal, MBBS, Institute of Medicine, Kathmandu, Nepal 
Suhana Chaulagain, MBBS, Patan Academy of Health Sciences, Kathmandu, Nepal 
Dr. Niraj Bam, Associate Professor, Institute of Medicine, Kathmandu, Nepal 
 
Title 
Quality of life among people living with Chronic Obstructive Pulmonary Disease- visiting 
spirometry center of Tribhuvan University Teaching Hospital, Kathmandu Nepal: A cross-
sectional study. 
 
Project Background 
Chronic obstructive pulmonary disease (COPD) is characterized by airflow limitation that is not 
fully reversible. The study “Quality of life among people living with Chronic Obstructive 
Pulmonary Disease- visiting spirometry center of Tribhuvan University Teaching Hospital, 
Kathmandu Nepal” aims to assess the quality of life (QOL) of COPD patients and the factors 
affecting it. 
 A cross sectional study will be performed among the patients visiting Spirometry center of 
Tribhuvan University Teaching Hospital, Kathmandu Nepal using Convenience Sampling. Ethical 
approval will be obtained from Institutional Review Board (IRB) of TUTH and written/verbal 
consent for data collection will be obtained from Teaching hospital authority as well as the 
respondents. St. George's respiratory questionnaire (SGRQ) will be used to assess quality of life 
and the Medical Research Council questionnaire will be used to assess the severity of dyspnea. 
Data management and analysis will be conducted through Epi-Data version 3.1 and Statistical 
Package for Social Sciences (SPSS) version 26.0.  
Introduction 
 
Chronic obstructive pulmonary disease (COPD) represents a complex respiratory disorder 
characterized by chronic airflow limitation and an increased inflammatory response of the airways 
(1) The Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines define COPD 
as a disease state characterized by airflow limitation that is not fully reversible, is usually 

progressive, and is associated with an abnormal inflammatory response of the lungs to inhaled 
noxious particles or gases,. Globally, 10%–20% of the population older than 40 years (an estimated 
80 million) are COPD sufferers, resulting in more than 3 million deaths each year (2, 3). In Nepal, 
COPD accounts for 43% of the non-communicable disease burden, and 2.56% of hospitalizations 
(4, 5). 
 
Though tobacco smoking is established as the primary cause of COPD, indoor air pollution from 
biomass and/or traditional fuels is estimated to be associated with 0.4 million deaths from acute 
symptoms of COPD (6). Studies have shown that smokers in Nepal have a 70% greater chance of 
developing COPD (4). In Nepal, more than 85% of households (98% in rural areas) still rely on 
biomass fuel (7). Nepalese women are at higher risk of developing COPD through exposure to 
indoor air pollution; additionally, about 15% of women also smoke tobacco (8, 9). 
 
Health-related quality of life (HRQOL) may have a major impact on COPD patients. They may 
have restriction of activities, decreased social functioning and loss of independence (10). Co-
morbidities are frequent in COPD and significantly impact on patients’ quality of life, exacerbation 
frequency, and survival (1, 11). Quality of life and self-reported health status decrease with an 
increasing number of co-morbidities in patients with COPD (11,12,13). The distinction between 
co-morbidities and systemic manifestations of COPD is, at present, unclear. Systemic features of 
COPD include cachexia, skeletal muscle abnormalities, osteoporosis, depression, anemia, and 
cardiovascular disease (1). 
 
COPD is a major public health problem because of its high prevalence, adverse impact on quality 
of life (QoL), (14) and large social and economic costs. (15) Psychological and behavioral factors 
may influence individual perceptions of symptom severity, and strategies used by patients to cope 
with the burden of symptoms and disability are still incompletely understood. (15) 
Acceptance of the disease has a significant impact on the level of assessment of quality of life in 
patients with COPD — the higher acceptance, the higher rating of quality of life. (16) COPD as a 
chronic illness has effects on social, psychological, and economic spheres of life. It has several 
significant extra-pulmonary effects, such as skeletal muscle impairment and exercise intolerance, 
which have an important effect on the daily life activities of patients with this disease (17, 18). 

Lower self-reported walking times are related to worse markers of disease severity in COPD (19). 
Moreover, reduced levels of physical activity have been found to be related to an increased risk of 
hospital admissions and mortality in COPD (20, 21). The American College of Sports Medicine 
recommends that older adults should perform at least 30 min of physical activity of moderate 
intensity, such as walking, most days of the week in order to maintain or develop fitness. (22) 
The Bagmati province  of Nepal consists of a privately-run medical college and many public 
hospitals, of which the TUTH is the referral center within the public hospital/health facility 
network in the province. Assessment of visits made to the TUTH helps identify the number of 
COPD cases. Therefore, the purpose of this study is to identify the quality of life among Chronic 
Obstructive Pulmonary Disease in Nepal through a cross-sectional study in TUTH. 
 
Rationale 
Despite the increasing trend of burden of COPD, little efforts have been made to combat Chronic 
Obstructive Pulmonary Diseases (COPD). There is very scare information in about the quality of 
life among COPD patients.  
Quality of life (QOL) is an important aspect for measuring the impact of chronic diseases. HRQOL 
measurement facilitates the evaluation of efficacy of medical interventions and also the detection 
of groups at risk. Many studies have been conducted across the world to study the HRQOL of 
COPD patients and the factors affecting it. However, studies from Nepal are far fewer in number. 
To fill this gap, we have proposed this research which would be helpful to find out the association 
between quality of life and chronic disease. Moreover, this will be useful to compare QOL of 
COPD patients of Nepal with other countries 
General Objective 
To assess the quality of life and identify its associated factors among people living with Chronic 
Obstructive Pulmonary Disease (COPD) visiting the spirometry center of Tribhuvan University 
Teaching Hospital, Kathmandu, Nepal. 
Specific Objectives 
1. To describe the socio-demographic, clinical, and exposure profiles of COPD patients. 

2. To assess the quality of life of COPD patients using the COPD Assessment Test (CAT) 
and determine the prevalence of different impact levels (low, medium, high). 
3. To analyze the relationship between quality of life (CAT score) and key clinical factors, 
including dyspnea severity (mMRC grade), lung function (FEV₁% predicted), and GOLD 
stage. 
4. To identify the factors independently associated with poor quality of life (defined as a 
CAT score >20) using multivariate logistic regression. 
 
Methodology 
Study design 
A cross-sectional study design employing quantitative research method will be done to fulfill the 
research purpose. The study will be hospital based and will be carried out in Institute of Medicine, 
Tribhuvan University Teaching Hospital, Maharajgunj, Kathmandu, Nepal.  
Sampling 
Non probability sampling will be done for four months visiting the spirometry center of TUTH. 
According to the spirometry center report average 30 patients visit in a month. Considering the 
non-response rate 20% we can collect data of 24 patients in a month. Considering this and duration 
of data collection, study aims to collect data from 96 patients.  
Data collection 
Data collection will be carried out by trained medical interns at the spirometry center. Following 
the provision of informed consent, participants underwent a face-to-face interview using a 
structured questionnaire to gather information on socio-demographics, smoking history, and 
biomass fuel exposure. Dyspnea severity was assessed using the modified Medical Research 
Council (mMRC) scale, and health-related quality of life was measured using the COPD 
Assessment Test (CAT). Anthropometric measurements and vital signs were recorded for each 
participant. Spirometry was performed pre- and post-bronchodilator administration in accordance 
with standard 4 guidelines to confirm COPD diagnosis and severity classification; all spirometric 
values were directly recorded onto a standardized data sheet. Medical Modified Research 
Council (mMRC) will be used to assess dyspnea scale. Spirometry report card will be observed 
and recorded for assessing the following parameters:  
a. Forced expiratory volume in the first second (FEV1) pre and post bronchodilator. 
Forced vital capacity (FVC). 
b. FEV1/FVC ratio. 
c. Peak expiratory flow rate (PEFR). 

d. Forced expiratory flow at 25%- 75% of maximal lung volume (FEF25–75%). 
 
Table 1: Tools and techniques of the data collection 
Techniques 
Tools 
Participants 
Data generated  
Structured interview 
CAT Questionnaire  
Sample Population 
Health related quality 
of life (HRQOL) 
Anthropometric 
measurement 
Digital 
weighing 
machine, measuring 
tape 
and 
portable 
standard stature scales 
Sample Population 
BMI, 
waist 
circumference 
Observation 
and 
structured interview 
Spirometry 
report 
card 
Sample population 
FEV1% 
and 
FEV1/FVC 
Structured interview 
Medical 
Research 
Council (mMRC) 
Sample Population 
Assess dyspnea scale 
 
 
 
Data collection and analysis plan 
Data collection will be carried out by trained medical interns at the spirometry center. Following 
the provision of informed consent, participants will undergo a face-to-face interview using a 
structured questionnaire to gather information on socio-demographics, smoking history, and 
biomass fuel exposure. Dyspnea severity will be assessed using the modified Medical Research 
Council (mMRC) scale, and health-related quality of life will be measured using the COPD 
Assessment Test (CAT). Anthropometric measurements and vital signs will be recorded for each 
participant. Spirometry will be performed pre- and post-bronchodilator administration in 
accordance with standard guidelines to confirm COPD diagnosis and severity classification; all 
spirometric values will be directly recorded onto a standardized data sheet. 
For statistical analysis, the parameters from the datasheet will first be entered into an Excel 
spreadsheet (Microsoft Corp., 2019). All analyses will be conducted in the Statistical Package for 
the Social Sciences (SPSS), version 29.0 (IBM Corp., Armonk, N.Y., USA). Descriptive 
statistics will be presented as means ± standard deviations for continuous variables and as 
frequencies and percentages for categorical variables. Bivariate analyses will be conducted using 
Pearson's or Spearman's correlation coefficients for continuous variables, independent samples t-
tests for dichotomous comparisons, and one-way ANOVA for comparisons across multiple groups. 
Multivariable analyses will include a linear regression to identify factors associated with the 
continuous COPD Assessment Test (CAT) score and a logistic regression to determine predictors 
of poor quality of life (defined as a CAT score > 20). Assumptions for all regression models will 
be checked and must be met. A two-tailed p-value of < 0.05 will be considered statistically 

significant. All figures, including the participant flow diagram, distribution plots, and scatter 
plot, will be generated using R software (R Foundation for Statistical Computing). 
 
 
 
Ethics 
Ethical approval will be taken from Ethical Review Board of the Nepal Health Research 
Council(NHRC) and Institutional Review Board (IRB) of TUTH . Written informed consent will 
be taken from the study participants. The study participants will be informed about the 
confidentiality of information collected and their right to withdraw from the study at any time. 
Preventive and promotional counseling will be given to the study population after the data 
collection and healthy tips for promoting quality of life will be shared.  
 
Potential impact of the project 
Our research is closely aligned with goal 3, target no. 4 of Sustainable Developments Goals (SDG): 
reducing the premature mortality of NCDs and Nepal’s Multi-sectorial action plan for the 
prevention and control of NCDs.It has spelled out the need to reduce the premature death due to 
NCDs with focus on prevention and treatment as well as decreasing the risk factors of NCDs. As 
COPD is the major burden of NCDs in Nepal, it can play crucial role in generating evidence and 
which ultimately helps in formulation and execution of plans and policies. In Institute of 
Medicine(IOM), we students celebrate many health related days and make patients aware of the 
healthy life.This research can help us to focus about different factors affecting COPD. This 
research will set the baseline information for developing patients based intervention for the 
prevention and management of COPD and uplifting the quality of life among them.  
So, the design and implementation of intervention package following the study will be conducted 
jointly by different organization available under Institute of Medicine, TUTH. 
 
Project Schedule 
Task to be performed 

Preparation 
and 
submission of research 
proposal  
Ethical clearance from 
NHRC 
Orientation 
to 
enumerators 
Data collection  
Data analysis 
Report 
writing 
and 
dissemination 
of 
preliminary 
study 
findings 
to 
IRC 
and 
TUTH 
Submission of final report 
to IRC and TUTH, IOM 
 
 
 
 
 
 
 
 
Budget 
S.N. Budget head 
Justification 
#units 
(days/months) Rate 
 
Total 
(NRs) 
Phase I: Study design and development 
1.1 
Human resources  
 
 
 
1.1.1 Research team  
Includes cost for data analysis, 
report writing and monitoring 
research work for research team 
members 
15 working 
days 
1000 15000 
1.1.2 Field supervisor 
Allowance 
1 
persons*4days 1000 4000 
1.1.3 Field enumerators Includes cost for field allowance 
2 * 32 
500 
19000 
 
 
 
Subtotal (1.1)  
30,000 

1.2 
Study tools and 
training 
  
  
  
  
1.2.1 Stationery 
For literature review and field 
level data collection  
Lump sum 
- 
5000 
1.2.2 Questionnaire  
For literature review and field 
level data collection  
1 
2000 2000 
1.2.3 Training for  
enumerators 
For data collection  
2 days 
25,00 5,000 
 
 
 
Subtotal (1.2)  
12,000 
Phase II: Field work organization  
2.2 
Communication 
expenses 
 
Lump sum 
 
1000 
  
  
 
 Sub total (2) 
  
1,000 
Phase III: Data management 
3.1 
Data analysis 
 
- 
- 
- 
3.2 
Report 
preparation  
Printing and binding 
Lump sum 
- 
3000 
3.4 
Miscellaneous  
other contingency costs  
Lump sum 
- 
1000 
  
  
 
 Sub total (3) 
  
4,000 
 
 
 
Subtotal  
(1.1+1.2+2+3) 
 
52,000 
 
Ethical approval 
cost 
 
 
 
1000 
  
  
Grand Total  
  
 
53,000 
 
 
References 
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diagnosis, 
management, 
and 
prevention 
of 
COPD; 
2014. 
Available 
from: 
http://www.goldcopd.org/. Accessed June 5, 2014. 
 
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Informed consent form 
"Quality of life among people living with Chronic 
Obstructive Pulmonary Disease- visiting spirometry center 
of Tribhuvan University Teaching Hospital, Kathmandu 
Nepal: A cross-sectional study." 
Maharajgunj Medical Campus, Tribhuvan University Teaching Hospital, Institute of Medicine 
Maharajgunj, Kathmandu, Nepal 
I, ............................................................. , a male/female of ............ years of age, have received 
information regarding this research to be conducted by ............................................................. by 
reading and/or listening to the attached 'Information Sheet/Booklet' and through a question-and-
answer session. 
• 
I understand that my participation in this research work depends entirely on my personal 
will, and that I can withdraw from this research process at any time if I wish. I have been 
made to understand that I do not need to provide any reason for this, and it will not affect 
the services I receive or my legal rights. 
• 
I understand that no personal identifying information about me will be published in the 
report of this research or in any related publications. 
• 
Knowing and understanding all these points, I voluntarily agree to participate in this 
study-research and hereby provide my signature on this Informed Consent Form. 
 
[Participant's] 
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Date : ......./....../...... (YYYY/MM/DD) 
 
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