Status:
UNKNOWN
Predict&Prevent: Use of a Personalised Early Warning Decision Support System to Predict and Prevent Acute Exacerbations of COPD
Lead Sponsor:
University of Birmingham
Collaborating Sponsors:
University Hospitals of North Midlands NHS Trust
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
COPD is a common complex disease with debilitating breathlessness; mortality and reduced quality of life, accelerated by frequent lung attacks (exacerbations). Changes in breathlessness, cough and/or ...
Detailed Description
Changes in dyspnoea, coughing and/or sputum production often precede exacerbations but as symptoms vary within-same day and across days, patients cannot easily judge the significance of such changes w...
Eligibility Criteria
Inclusion
- Clinically diagnosed chronic obstructive pulmonary disease (COPD), confirmed by post-bronchodilator spirometry and defined as a ratio of Forced Expiratory VolumeFEV1 to Forced Vital Capacity \<0.7 and \<lower limit of normal for age post bronchodilator use
- ≥2 Acute Exacerbations of COPD (AECOPD) in the previous 12 months according to the patient and/or ≥1 hospital admission for AECOPD
- Exacerbation free for at least 6 weeks
- An age of at least 18 years
- Willing and able to comply with the data collection process out to 12 months from randomisation
- Ability to consent
- Ability to use intervention as judged by the investigator at screening, upon demonstration of the system to the patient
Exclusion
- Life expectancy \< 12 months
- Patients with active infection, unstable co-morbidities at enrolment or very severe comorbidities such as grade IV heart failure, renal failure on haemodialysis or active neoplasia or significant cognitive impairment;
Key Trial Info
Start Date :
October 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2023
Estimated Enrollment :
384 Patients enrolled
Trial Details
Trial ID
NCT04136418
Start Date
October 7 2020
End Date
March 31 2023
Last Update
November 1 2022
Active Locations (1)
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1
University Hospitals Coventry & Warwickshire Trust
Coventry, England, United Kingdom, CV2 2DX