A Cross-sectional Study of COPD and Symptom Variability in MEA Countries (COPVAR)
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|ClinicalTrials.gov Identifier: NCT03425760|
Recruitment Status : Completed
First Posted : February 8, 2018
Last Update Posted : February 8, 2018
This non-interventional study aims at assessing stable GOLD C and D COPD patient's perception of daily and weekly symptoms variability and their impact on daily activities.
It will also explore the current practice in management of stable GOLD C and D COPD patients.
|Condition or disease|
|Chronic Obstructive Pulmonary Disease|
- Primary objective: To assess perception of daily and weekly variability of symptoms in stable GOLD C and D COPD patients and their impact on daily life activities
- To describe the current treatment practice for the management of GOLD C and D COPD in MEA countries and their adherence to the GOLD 2015 guidelines
- To compare patients' perception of symptoms variability and their impact on activities between Gold categories C and D
- To identify demographic, behavioral and clinical factors associated with symptoms variability.
|Study Type :||Observational|
|Actual Enrollment :||3092 participants|
|Official Title:||A Cross-sectional Study of COPD and Symptom Variability in MEA Countries|
|Actual Study Start Date :||December 7, 2015|
|Actual Primary Completion Date :||March 31, 2017|
|Actual Study Completion Date :||March 31, 2017|
- Perception of symptoms variability in Chronic obstructive pulmonary disease(COPD) patients [ Time Frame: 1 Year ]Mean score of Morning Activities and Symptoms Questionnaires (MASQ). MASQ is a patient-reported outcome instrument developed to measure morning activities and morning symptoms. The MASQ consist of two parts that captures instant symptoms through the Global Chest Symptoms Questionnaire (GCSQ), and morning activities through the Capacity of Daily Living during the morning (CDLM) questionnaire. Each item is rated on a 5 point Likert scale, from 0 (not at all) to 4 (extremely), the total score being calculated as the average score of the two questions. Score Range a score ranging from 0 (so difficult that the activity could not be carried out by the patient on their own) to 5 (activity was not at all difficult to carry out).
- Impact of symptom variability on daily life activities of Chronic obstructive pulmonary disease(COPD) Patients [ Time Frame: 1 Year ]Percentage of patients whose daily activities are affected as captured in the Chronic obstructive pulmonary disease(COPD) Assessment Test(CAT). CAT IS a questionnaire that assesses the impact of COPD (cough, sputum, dyspnoea, chest tightens) on health status. There are eight questions with a scale of 1 to 5. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life. The difference between stable and exacerbation patients was five units. No target score represents the best achievable outcome.
- Current treatment practice for the management of COPD in Middle East Africa countries and their adherence to The Global Initiative for Chronic Obstructive Lung Disease(GOLD 2015) guidelines [ Time Frame: 1 Year ]Patients whose treatment is adherent with The Global Initiative for Chronic Obstructive Lung Disease(GOLD) 2015 in Percentage