Clinical and cost-effectiveness of SPACE for COPD delivered as a pulmonary rehabilitation maintenance programme: a randomised controlled trial

INTRODUCTION: The benefits of pulmonary rehabilitation (PR) decline after 6-12 months. Previous studies of maintenance in the literature have been labour-intensive and concentrated on secondary care healthcare utilisation only. We aimed to investigate whether Self-management Programme of Activity, Coping and Education (SPACE) for chronic obstructive pulmonary disease (COPD), a light-touch self-management programme, was clinically and cost-effective following PR. METHODS: We conducted a prospective, multicentre, assessor-blind randomised controlled trial. Patients with COPD were randomised 1:1 to usual care (control) or SPACE. The intervention included a home-based manual and four facilitated group sessions, delivered over 12 months. PRIMARY OUTCOME: Endurance Shuttle Walking Test at 12 months. SECONDARY OUTCOMES: maximal exercise capacity, mood, patient activation, physical activity, healthcare costs and health-related quality-of-life (HRQoL). RESULTS: 116 participants were recruited (October 2019-June 2022). Baseline characteristics: SPACE (65% male, aged 71.8 years, median Medical Research Council (MRC) 3, mean pack years 41.1, mean body mass index (BMI) 29.1), control (51% male, aged 71.8 years, median MRC 3, mean pack years 44.5, mean BMI 28.3). SPACE completion rate=83% and intervention fidelity (assessed via checklist) was excellent. No statistically significant differences at 12 months for primary and secondary outcomes. Economic analysis at 12 months shows a positive HRQoL difference between groups of 0.0871 quality adjusted life years (QALY) and reduced National Health Service (NHS) costs of £139 per participant, driven primarily by a reduction in general practitioner visits in favour of SPACE. CONCLUSIONS: Endurance exercise tolerance was maintained in both groups. The programme improved HRQoL at 12 months in the intervention group (above control) and was cost-effective, driven by reduced primary care costs.