Clinical trial NCT02771678: Estimating Quality of Life in People With Asthma
Official title: Estimating the Loss in Quality of Life Associated With an Asthma Related Crisis Event (ESQUARE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lead sponsor: University of East Anglia
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2016-05-13
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: EuroQol 5 Dimensions 5 Level (EQ-5D-5L)
timeFrame: Once a week from baseline until week 8
measure: Asthma Quality of Life Questionnaire (AQLQ)
timeFrame: Once a month from baseline to week 8
measure: Peak flow and asthma symptom diary
timeFrame: Every day from baseline to week 8
measure: Time Trade-Off
timeFrame: Once a month from baseline to week 8
Secondary outcomes:
measure: Productivity Questionnaire
timeFrame: Week 4
Other outcomes:
Locations:
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospital
state: Select A County
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital Birmingham
Study officials:
affiliation: University of East Anglia
name: Christina-Jane Crossman-Barnes, BSc, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of East Anglia
name: Andrew Wilson, MD FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Crossman-Barnes CJ, Sach T, Wilson A, Barton G. Estimating loss in quality of life associated with asthma-related crisis events (ESQUARE): a cohort, observational study. Health Qual Life Outcomes. 2019 Apr 11;17(1):58. doi: 10.1186/s12955-019-1138-5.