Estimating Quality of Life in People With Asthma

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02771678
• Other study ID #: 16/EE/0023
• Status: Completed
• Start date: May 2016
• Est. completion date: July 25, 2017

Study information

• Verified date: October 2016
• Source: University of East Anglia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: July 25, 2017
• Est. primary completion date: July 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
United Kingdom	Aberdeen Royal Infirmary	Aberdeen
United Kingdom	Queen Elizabeth Hospital Birmingham	Birmingham
United Kingdom	Norfolk and Norwich University Hospital	Norwich	Select A County

Sponsors (2)

Lead Sponsor	Collaborator
University of East Anglia	National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EuroQol 5 Dimensions 5 Level (EQ-5D-5L)	A generic quality of life questionnaire	Once a week from baseline until week 8
Primary	Asthma Quality of Life Questionnaire (AQLQ)	A disease-specific quality of life questionnaire	Once a month from baseline to week 8
Primary	Peak flow and asthma symptom diary	Assessment of peak expiratory flow and asthma symptoms	Every day from baseline to week 8
Primary	Time Trade-Off	Assessment of quality of life. Completed at Norfolk and Norwich University Hospital only.	Once a month from baseline to week 8
Secondary	Productivity Questionnaire	Assessment of time lost from work, study or activities from having an asthma exacerbation	Week 4