AsthmaNCT02771678
Estimating Quality of Life in People With Asthma
An observational study of Asthma, run by University of East Anglia at 3 sites in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- How many people
- 121 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- May 2016to 25 Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Asthma patients who have an asthma-related crisis event (attended A\&E or have been admitted to hospital).
Who may be able to join
- 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
Who cannot join
- Younger than 18 years old
- Does not speak English
- Has participated in the study before
- Remains hypoxemic despite oxygen therapy
- Impaired capacity to consent
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Aberdeen Royal Infirmary
Aberdeen, AB25 2ZN
Queen Elizabeth Hospital Birmingham
Birmingham, B15 2GW
Norfolk and Norwich University Hospital
Norwich, Select A County, NR4 7TJ
About this study
Official title: 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).
Read the 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.
- Conditions
- Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
EuroQol 5 Dimensions 5 Level (EQ-5D-5L)
A generic quality of life questionnaire
Measured: Once a week from baseline until week 8
Asthma Quality of Life Questionnaire (AQLQ)
A disease-specific quality of life questionnaire
Measured: Once a month from baseline to week 8
Peak flow and asthma symptom diary
Assessment of peak expiratory flow and asthma symptoms
Measured: Every day from baseline to week 8
Time Trade-Off
Assessment of quality of life. Completed at Norfolk and Norwich University Hospital only.
Measured: Once a month from baseline to week 8
Secondary outcomes (1)
Productivity Questionnaire
Assessment of time lost from work, study or activities from having an asthma exacerbation
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study startMay 2016
- Primary completion25 Jul 2017
- Study completion25 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of East Anglia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Christina-Jane Crossman-Barnes, BSc, MSc, Principal investigator, University of East AngliaAndrew Wilson, MD FRCP, Principal investigator, University of East Anglia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02771678
- Sponsor's protocol ID
- 16/EE/0023
- Status last verified
- Oct 2016
- First submitted
- 5 May 2016
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30971261
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimating the Loss in Quality of Life Associated With an Asthma Related Crisis Event (ESQUARE)
- ClinicalTrials.gov ID
- NCT02771678
- Acronym / sponsor ID
- 16/EE/0023
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- University of East AngliaUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- May 2016
- Primary completion
- 25 Jul 2017 (actual)
- Study completion
- 25 Jul 2017 (actual)
- First posted
- 13 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Asthma patients who have an asthma-related crisis event (attended A\&E or have been admitted to hospital).
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- Younger than 18 years old
- Does not speak English
- Has participated in the study before
- Remains hypoxemic despite oxygen therapy
- Impaired capacity to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
EuroQol 5 Dimensions 5 Level (EQ-5D-5L)
Time frame: Once a week from baseline until week 8
A generic quality of life questionnaire
Asthma Quality of Life Questionnaire (AQLQ)
Time frame: Once a month from baseline to week 8
A disease-specific quality of life questionnaire
Peak flow and asthma symptom diary
Time frame: Every day from baseline to week 8
Assessment of peak expiratory flow and asthma symptoms
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.
1 secondary outcome
Productivity Questionnaire
Time frame: Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
- Derived from this study: PubMed 30971261Crossman-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina-Jane Crossman-Barnes, BSc, MSc principal investigator
University of East Anglia
Andrew Wilson, MD FRCP principal investigator
University of East Anglia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by University of East Anglia at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EuroQol 5 Dimensions 5 Level (EQ-5D-5L) (time frame: Once a week from baseline until week 8). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02771678, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2018.