Chronic Obstructive Pulmonary Disease, Quality of Life, COPD Assessment Test, Nepal, Dyspnea, Spirometry

NCT ID: NCT07261813

Last Updated: 2025-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

71 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-01

Study Completion Date

2026-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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COPD (Chronic Obstructive Pulmonary Disease) Quality of Life

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Evaluation of Quality of life in COPD patients

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

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

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of medicine, Maharagjung medical campus

OTHER

Sponsor Role lead

Responsible Party

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Abhishek Kumar Shah

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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353 (6-11) E2 077/ 078

Identifier Type: -

Identifier Source: org_study_id

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