Preprint · Jun 10, 2026
Protocol for a cluster randomized controlled trial for patients with chronic obstructive pulmonary diseases and comorbidities: Better Breathe with Advanced Self-management and Integrated Care (BASIC) study (Preprint)
By Guan X, Shi Z, Wei X et al.
BACKGROUND Chronic obstructive pulmonary disease (COPD) is a global health burden, with 44.7% of Chinese COPD patients aged above 40 having comorbidities (predominantly hypertension and type 2 diabetes) that worsen prognosis. Despite national efforts to integrate COPD into Essential Public Health Services, no rigorous trial has evaluated integrated care for this multimorbid population in resource-limited primary care. OBJECTIVE To develop an integrated care package for COPD patients with hypertension/type 2 diabetes, evaluate its effects on key outcomes (COPD exacerbations, blood pressure, glucose), explore its sustainability and scalability, and assess cost-effectiveness. METHODS The BASIC study is a two-arm, parallel, cluster randomised controlled trial in 8 township health centres in Shanxian, Shandong Province. We will recruit 556 adults (aged 35–75 years) with post-bronchodilator FEV1/FVC <70% and comorbid hypertension or type 2 diabetes. Clusters are stratified by geography and service performance, then randomly allocated (1:1) to a 12-month intervention or usual care. The intervention delivers multidisciplinary team management, 10 structured follow-up contacts, personalised clinical and behavioural adjustments, and horizontal and vertical care integration. Controls receive standard Essential Public Health Services (4 follow-ups). Co-primary outcomes are COPD exacerbation frequency and control rates of hypertension/diabetes. Secondary outcomes include quality of life (EQ-5D), COPD symptoms (CAT), 6-minute walk distance, activities of daily living, depression (CESD-10), healthcare utilisation, and costs. Generalised linear mixed models will account for clustering. Economic evaluation will estimate incremental cost-effectiveness ratios and cost-utility. Qualitative process evaluation will identify implementation determinants. RESULTS Not Applicable CONCLUSIONS The BASIC study will provide the first rigorous evidence on integrated care for COPD multimorbidity in rural Chinese primary care, with direct implications for national policy scale-up. CLINICALTRIAL Chinese Clinical Trial Registry, ChiCTR2400095000