Estimating Quality of Life in People With Asthma

Completed

• Conditions: Asthma

• Registration Number: NCT02771678
• Lead Sponsor: University of East Anglia

Brief Summary

The aim of this project is to estimate the quality of life for people with asthma and specifically the loss in quality of life associated with an asthma-related crisis event (accident and emergency (A\&E) attendance or admission).

Detailed Description

Asthma is a serious respiratory condition which causes shortness of breath, chest tightness and wheezing. Quality of life can have an impact on asthmatics due to such symptoms. Previous studies capture quality of life at specific time points (e.g. baseline, 1 month, 3 months), and the assumption of a steady improvement is made. However, these assumptions and time points could miss an asthma event in between. Therefore, the investigators aim to provide a more accurate estimation of the loss in quality of life by following participants over an 8 week period from when the participants have attended A\&E or been admitted to hospital following an asthma attack. This will be done by using different quality of life methods, and analysed by calculating the difference between the quality of life scores from A\&E attendance / hospital admission and follow-ups.

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-05
• Study First Submitted QC: 2016-05-10
• Study First Posted: 2016-05-13
• Status Verified: 2016-10
• Primary Completion: 2017-07-25
• Study Completion: 2017-07-25
• Last Update Submitted: 2018-05-02
• Last Update Posted: 2018-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

Inclusion Criteria

• Male or Female 18 years old and over
• Has asthma alone, or asthma with Chronic Obstructive Pulmonary Disease (COPD) or asthma with a respiratory infection
• Speaks English
• Not in need of help from carer / guardian to complete questionnaires
• Not hypoxemic
• Not participated in the study before
• Able to give informed consent

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Exclusion Criteria

• Younger than 18 years old
• Does not speak English
• Has participated in the study before
• Remains hypoxemic despite oxygen therapy
• Impaired capacity to consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Asthma Quality of Life Questionnaire (AQLQ)	Once a month from baseline to week 8	A disease-specific quality of life questionnaire
Time Trade-Off	Once a month from baseline to week 8	Assessment of quality of life. Completed at Norfolk and Norwich University Hospital only.
EuroQol 5 Dimensions 5 Level (EQ-5D-5L)	Once a week from baseline until week 8	A generic quality of life questionnaire
Peak flow and asthma symptom diary	Every day from baseline to week 8	Assessment of peak expiratory flow and asthma symptoms

Secondary Outcome Measures

Name	Time	Method
Productivity Questionnaire	Week 4	Assessment of time lost from work, study or activities from having an asthma exacerbation

Trial Locations

Locations (3)

Norfolk and Norwich University Hospital; 🇬🇧 Norwich, Select A County, United Kingdom

Aberdeen Royal Infirmary; 🇬🇧 Aberdeen, United Kingdom

Queen Elizabeth Hospital Birmingham; 🇬🇧 Birmingham, United Kingdom