Estimating Quality of Life in People With Asthma

May 2, 2018 updated by: University of East Anglia

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

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).

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

121

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZN
        • Aberdeen Royal Infirmary
      • Birmingham, United Kingdom, B15 2GW
        • Queen Elizabeth Hospital Birmingham
    • Select A County
      • Norwich, Select A County, United Kingdom, NR4 7TJ
        • Norfolk and Norwich University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Asthma patients who have an asthma-related crisis event (attended A&E or have been admitted to hospital).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Asthma
All participants will have an asthma-related crisis event due to an asthma exacerbation that resulted in A&E attendance and/or hospital admission.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EuroQol 5 Dimensions 5 Level (EQ-5D-5L)
Time Frame: Once a week from baseline until week 8
A generic quality of life questionnaire
Once a week from baseline until week 8
Asthma Quality of Life Questionnaire (AQLQ)
Time Frame: Once a month from baseline to week 8
A disease-specific quality of life questionnaire
Once a month from baseline to week 8
Peak flow and asthma symptom diary
Time Frame: Every day from baseline to week 8
Assessment of peak expiratory flow and asthma symptoms
Every day from baseline to week 8
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.
Once a month from baseline to week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Productivity Questionnaire
Time Frame: Week 4
Assessment of time lost from work, study or activities from having an asthma exacerbation
Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of East Anglia

Collaborators

National Institute for Health Research, United Kingdom

Investigators

  • Principal Investigator: Christina-Jane Crossman-Barnes, BSc, MSc, University of East Anglia
  • Principal Investigator: Andrew Wilson, MD FRCP, University of East Anglia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

July 25, 2017

Study Completion (Actual)

July 25, 2017

Study Registration Dates

First Submitted

May 5, 2016

First Submitted That Met QC Criteria

May 10, 2016

First Posted (Estimate)

May 13, 2016

Study Record Updates

Last Update Posted (Actual)

May 3, 2018

Last Update Submitted That Met QC Criteria

May 2, 2018

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16/EE/0023

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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