NCT04136418.

Study name	A Randomised Designed Clinical Investigation of the Use of a Personalised Early Warning Decision Support System With Novel Saliva Bio‐profiling to Predict and Prevent Acute Exacerbations of Chronic Obstructive Pulmonary Disease
Methods	Multi‐centre, open label RCT with 12 months ' follow‐up Aim: t o investigate if a smart digital health intervention (COPDPredict™) can be used by both COPD patients and clinicians to improve self‐management, predict lung attacks early, intervene promptly, and avoid hospitalisation
Participants	People with clinically diagnosed and confirmed COPD with ≥ 2 acute exacerbations of COPD (AECOPD) in the previous 12 months according to the patient and/or ≥ 1 hospital admission for AECOPD
Interventions	COPDPredict™, which consists of a patient‐facing app and a clinician‐facing smart early warning decision support system. The app on a mobile device is used by patient s to track the status of their COPD and to inform the patient's care team
Outcomes	AECOPD‐related hospital admissions, inpatient days, COPD exacerbations, ED visits, symptom control markers, CAT, EQ‐5D, lifestyle choices, FEV ₁, C‐reactive protein during exacerbations
Starting date	Starting date: September 2020; estimation completion date: September 2022
Contact information	Rachael O'Beney; Rachael.O'Beney@uhcw.nhs.uk
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