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Completed

NCT Number: NCT02771678

Estimating Quality of Life in People With Asthma

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).

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Norfolk and Norwich University Hospital, Norwich, Select A County, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Primary outcomes

  1. EuroQol 5 Dimensions 5 Level (EQ-5D-5L)

    Time frame: Once a week from baseline until week 8

    A generic quality of life questionnaire

  2. Asthma Quality of Life Questionnaire (AQLQ)

    Time frame: Once a month from baseline to week 8

    A disease-specific quality of life questionnaire

  3. Peak flow and asthma symptom diary

    Time frame: Every day from baseline to week 8

    Assessment of peak expiratory flow and asthma symptoms

  4. Time Trade-Off

    Time frame: Once a month from baseline to week 8

    Assessment of quality of life. Completed at Norfolk and Norwich University Hospital only.

Secondary outcomes

  1. Productivity Questionnaire

    Time frame: Week 4

    Assessment of time lost from work, study or activities from having an asthma exacerbation

Sponsors and collaborators

Lead sponsor

University of East Anglia

Other

Collaborators

  • National Institute for Health Research, United Kingdom

Registry information

Official study title

Estimating the Loss in Quality of Life Associated With an Asthma Related Crisis Event (ESQUARE)

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 13, 2016
Registry last updated
May 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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