NCT02771678

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2016

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 13, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2017

Completed
Last Updated

May 3, 2018

Status Verified

October 1, 2016

Enrollment Period

1.2 years

First QC Date

May 5, 2016

Last Update Submit

May 2, 2018

Conditions

Outcome Measures

Primary Outcomes (4)

  • EuroQol 5 Dimensions 5 Level (EQ-5D-5L)

    A generic quality of life questionnaire

    Once a week from baseline until week 8

  • Asthma Quality of Life Questionnaire (AQLQ)

    A disease-specific quality of life questionnaire

    Once a month from baseline to week 8

  • Peak flow and asthma symptom diary

    Assessment of peak expiratory flow and asthma symptoms

    Every day from baseline to week 8

  • 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 Outcomes (1)

  • Productivity Questionnaire

    Week 4

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Younger than 18 years old
  • Does not speak English
  • Has participated in the study before
  • Remains hypoxemic despite oxygen therapy
  • Impaired capacity to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Norfolk and Norwich University Hospital

Norwich, Select A County, NR4 7TJ, United Kingdom

Location

Aberdeen Royal Infirmary

Aberdeen, AB25 2ZN, United Kingdom

Location

Queen Elizabeth Hospital Birmingham

Birmingham, B15 2GW, United Kingdom

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Christina-Jane Crossman-Barnes, BSc, MSc

    University of East Anglia

    PRINCIPAL INVESTIGATOR
  • Andrew Wilson, MD FRCP

    University of East Anglia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2016

First Posted

May 13, 2016

Study Start

May 1, 2016

Primary Completion

July 25, 2017

Study Completion

July 25, 2017

Last Updated

May 3, 2018

Record last verified: 2016-10

Locations