NCT07261813

Brief Summary

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. CAT questionnaire 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 Statistical Package for Social Sciences (SPSS) version 26.0.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
71

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2025

Completed
17 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2025

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

December 3, 2025

Status Verified

November 1, 2025

Enrollment Period

1 month

First QC Date

November 14, 2025

Last Update Submit

November 28, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Health-Related Quality of Life (HRQoL) Score (COPD Assessment Test - CAT)

    The COPD Assessment Test (CAT) score ranges from 0 to 40, with 0 indicating no impact and 40 indicating the worst impact on quality of life. Higher scores represent worse outcomes.

    1 month

Interventions

This study does not involve a clinical intervention. Instead, it focuses on evaluating Quality of life of COPD patient using the COPD Assessment Test (CAT). It is a validated, patient-completed questionnaire designed to assess the impact of Chronic Obstructive Pulmonary Disease (COPD) on a patient's health status. It consists of eight simple questions, each scored from 0 to 5, covering symptoms such as cough, sputum production, chest tightness, breathlessness, activity limitation, confidence leaving home, sleep quality, and energy levels. The total score ranges from 0 to 40, with higher scores indicating a greater impact of COPD on the patient's daily life. A score of 0-10 suggests a low impact, 11-20 a medium impact, 21-30 a high impact, and 31-40 a very high impact. The CAT is easy to administer, typically taking less than two minutes to complete, and provides clinicians with a standardized way to monitor disease progression and evaluate treatment effectiveness.

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study enrolled participants aged 20 years or older who were referred to the spirometry center of Tribhuvan University Teaching Hospital. The primary inclusion criterion was a confirmed diagnosis of COPD based on the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria, defined as a postbronchodilator ratio of forced expiratory volume in one second to forced vital capacity (FEV1/FVC) \< 0.70.

You may qualify if:

  • Age ≥ 20 years
  • Referred to the spirometry center of Tribhuvan University Teaching Hospital
  • Confirmed diagnosis of COPD based on GOLD criteria: post-bronchodilator FEV1/FVC \< 0.7

You may not qualify if:

  • Unable to perform acceptable spirometry maneuvers
  • Presence of significant respiratory diseases that can confound COPD assessment (e.g., asthma, bronchiectasis, active tuberculosis)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 14, 2025

First Posted

December 3, 2025

Study Start

December 1, 2025

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

December 3, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Since this is an observational study focused on evaluating the quality of life of COPD patients, Individual Participant Data (IPD) will not be shared as part of the study's results. However, the aggregated findings, such as overall satisfaction scores and analysis of demographic factors influencing consent understanding, will be presented in the final study report.