Aim

To test the hypothesis that COPDPredict^TM can produce a reduction in AECOPD hospitalisations (where the primary reason for admission is AECOPD) in the 12 months post randomisation, when compared to SSMP.

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Clinical Investigation Design

A phase III, 2 arm parallel-group, multi-centre, open label, individually randomised clinical investigation of 384 patients in a 1:1 ratio, to receive either a standard self-management plan and rescue medication pack (standard arm) or the COPDPredict^TM self-management system and rescue medication pack (intervention arm).

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Outcome Measures

Primary outcomes

The number of hospital admissions up to 12 months post randomisation, where the primary reason for admission is AECOPD

Secondary outcomes:

Over a 12 month period, following randomisation;

• Total inpatient days
• Number of patient defined exacerbations
• Number of visits to Accident and Emergency (A&E)
• Symptom control markers, specifically the amount of breathlessness and sputum (Anthonisen criteria)
• End-user experience (technology acceptability usability/utility via questionnaires and interviews);
• Health-related quality of life (COPD Assessment Test, CAT^TM and EQ-5D-5L);
• Lifestyle choices via App usage/questionnaires/interviews;
• Blood and salivary C-Reactive Protein (CRP) levels
• FEV₁ at 12 months
• Social acceptability and practical responses to the intervention, including any implementation issues