Observational Study Of An Electronic Questionnaire In Patients With Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
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Brief Summary
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The aim of the study is to develop a new patient-reported outcome (PRO) questionnaire measuring the impact of an acute exacerbation on daily lives of patients with chronic obstructive pulmonary disease (COPD). This questionnaire will aim to detect an acute exacerbation and resolution of exacerbation from the patient's perspective. At a later stage of development, this questionnaire will be able to measure the effect of anti bacterials in the treatment of acute exacerbations of COPD (AECOPD). This study will evaluate the factor structure, validity, reliability, and responsiveness of the GSK questionnaire in subjects who experience acute exacerbations of their COPD.

Official Title
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A Prospective Observational Study for the Psychometric Validation of a Patient-reported Questionnaire in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)

Conditions
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Pulmonary Disease, Chronic Obstructive, Infections, Bacterial

Intervention / Treatment
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* Other: GSK questionnaire
* Other: St. George's Respiratory Questionnaire
* Other: Acute Short Form 12 version 2
* Other: Global Efficacy questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 15 pack-year smoking history. Confirmed diagnosis of COPD. Have two documented episodes of acute exacerbation in past 12 months. Exclusion Criteria: Clinical diagnosis of asthma. Subjects not literate in the language of the questionnaire (e.g. US English).

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects with COPD<br>Subject has a confirmed clinical diagnosis of COPD, with or without chronic bronchitis. | Other: GSK questionnaire<br>* GSK questionnaire will demonstrate the validity, reliability and responsiveness as a tool for measuring subject-reported outcomes during an acute exacerbation of chronic obstructive pulmonary disease.<br>Other: St. George's Respiratory Questionnaire<br>* The SGRQ is a 50-item questionnaire with 76 weighted responses. It provides a Total score and three component scores: Symptoms (distress caused by respiratory symptoms), Activity (physical activities that cause or are limited by breathlessness), and Impacts (social and psychological effects of the disease). The Total score and each of the SGRQ sub-scores are scored from 0 to 100 where 0 indicates best and 100 indicates worst health.<br>Other: Acute Short Form 12 version 2<br>* The Acute SF-12v2 is a multipurpose short-form questionnaire with only 12 questions with two summary scores, the SF-12 Physical Component Summary (PCS-12) and the SF-12 Mental Component Summary (MCS-12). The scoring range for the PCS-12 and MCS-12 is 0 to 100, with a lower score indicating a poorer level of health<br>Other: Global Efficacy questionnaire<br>* Global Efficacy questionnaire will be administered in an electronic form to validate test-retest reliability, responsiveness and minimum important difference (MID)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| St. George's Respiratory Questionnaire (SGRQ) Scores at Baseline | The SGRQ is a 50-item questionnaire with 76 weighted responses. It provides a Total score and three component scores: Symptoms (distress caused by respiratory symptoms), Activity (physical activities that cause or are limited by breathlessness), and Impacts (social and psychological effects of the disease). The Total score and each of the SGRQ sub-scores are scored from 0 to 100 where 0 indicates best and 100 indicates worst health. An increase in score indicates worsening health. A change in the Total score of 4 units is consistent with a clinically significant change in the subject | Day 1 | 
| SGRQ Scores at exacerbation | The SGRQ is a 50-item questionnaire with 76 weighted responses. It provides a Total score and three component scores: Symptoms (distress caused by respiratory symptoms), Activity (physical activities that cause or are limited by breathlessness), and Impacts (social and psychological effects of the disease). The Total score and each of the SGRQ sub-scores are scored from 0 to 100 where 0 indicates best and 100 indicates worst health. An increase in score indicates worsening health. A change in the Total score of 4 units is consistent with a clinically significant change in the subject | Up to Day 14 | 
| SGRQ Scores post-exacerbation | The SGRQ is a 50-item questionnaire with 76 weighted responses. It provides a Total score and three component scores: Symptoms (distress caused by respiratory symptoms), Activity (physical activities that cause or are limited by breathlessness), and Impacts (social and psychological effects of the disease). The Total score and each of the SGRQ sub-scores are scored from 0 to 100 where 0 indicates best and 100 indicates worst health. An increase in score indicates worsening health. A change in the Total score of 4 units is consistent with a clinically significant change in the subject | Up to Day 14 | 
| Acute Short Form 12 version 2 (Acute SF-12v2) scores at Baseline | The Acute SF-12v2 is a multipurpose short-form questionnaire with only 12 questions with two summary scores, the SF-12 Physical Component Summary (PCS-12) and the SF-12 Mental Component Summary (MCS-12). The scoring range for the PCS-12 and MCS-12 is 0 to 100, with a lower score indicating a poorer level of health. It has been translated and validated in most major languages. The Acute SF-12v2 is self-administered by patients, and completed on average in 2 minutes or less. | Day 1 | 
| Acute SF-12v2 scores at exacerbation | The Acute SF-12v2 is a multipurpose short-form questionnaire with only 12 questions with two summary scores, the SF-12 Physical Component Summary (PCS-12) and the SF-12 Mental Component Summary (MCS-12). The scoring range for the PCS-12 and MCS-12 is 0 to 100, with a lower score indicating a poorer level of health. It has been translated and validated in most major languages. The Acute SF-12v2 is self-administered by patients, and completed on average in 2 minutes or less. | Up to Day 14 | 
| Acute SF-12v2 scores post-exacerbation | The Acute SF-12v2 is a multipurpose short-form questionnaire with only 12 questions with two summary scores, the SF-12 Physical Component Summary (PCS-12) and the SF-12 Mental Component Summary (MCS-12). The scoring range for the PCS-12 and MCS-12 is 0 to 100, with a lower score indicating a poorer level of health. It has been translated and validated in most major languages. The Acute SF-12v2 is self-administered by patients, and completed on average in 2 minutes or less. | Up to Day 14 | 
| Global Efficacy questionnaire scores at Baseline | Global Efficacy questionnaire will be administered in an electronic form to validate test-retest reliability, responsiveness and minimum important difference (MID) | Day 1 | 
| Global Efficacy questionnaire scores at exacerbation | Global Efficacy questionnaire will be administered in an electronic form to validate test-retest reliability, responsiveness and minimum important difference (MID) | Up to Day 14 | 
| Global Efficacy questionnaire scores post-exacerbation | Global Efficacy questionnaire will be administered in an electronic form to validate test-retest reliability, responsiveness and minimum important difference (MID) | Up to Day 14 | 
| Physician reported measures at Baseline |  | Day 1 | 
| Physician reported measures at exacerbation |  | Up to Day 14 | 
| Physician reported measures post-exacerbation |  | Up to Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in SGRQ-C Total and Subscales Scores |  | Up to Day 14 | 
| Percentage change in SGRQ-C scores |  | Up to Day 14 | 
| Change from Baseline in Acute SF-12v2 Total and Subscales Scores |  | Up to Day 14 | 
| Percentage change in Acute SF-12v2 scores |  | Up to Day 14 | 
| Change from Baseline in Global Efficacy Questionnaire Total and Subscales Scores |  | Up to Day 14 | 
| Percentage change in Global Efficacy Questionnaire scores |  | Up to Day 14 | 
| Change from Baseline in GSK questionnaire Total and Subscales Scores |  | Up to Day 14 | 
| Percentage change in GSK questionnaire scores |  | Up to Day 14 | 
| Time to resolution of each domain score |  | Up to Day 35 | 
| Time to resolution of total domain score |  | Up to Day 35 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient reported outcomes, COPD, acute exacerbation of chronic obstructive pulmonary disease (AECOPD)