Integrated Care for Hypertension-Diabetes Comorbidity in China: COMPACT-HTDM Trial Design and Baseline Characteristics

Background Hypertension and type 2 diabetes frequently coexist in older adults in China, yet routine primary care remains largely single-disease oriented, contributing to fragmented follow-up, medication complexity, and poor integrated risk-factor control. Objective To describe the design and baseline characteristics of COMPACT-HTDM, a trial evaluating integrated hypertension–diabetes management embedded in routine primary care. Methods COMPACT-HTDM is a pragmatic, two-arm cluster randomized controlled trial in three Jiangxi study areas, China. Twenty-four primary care institutions were randomized 1:1 to integrated comorbidity-oriented management or usual care. Eligible participants were adults aged 60 to 74 years with physician-diagnosed hypertension and type 2 diabetes for at least 6 months and recent chronic disease management. The intervention combines medication verification and safety management, monthly structured comorbidity follow-up, and health education with self-management support. The primary outcome is 6-month simultaneous blood pressure and glycemic control, defined as blood pressure <130/80 mm Hg and HbA1c <7.0%. Analyses will account for clustering. Results 1,010 participants completed baseline assessment: 504 in intervention clusters and 506 in usual-care clusters. Groups were well balanced. Mean age was 66.7 years, 578 participants (57.2%) were women, and 631 (62.5%) had primary school education or below. Despite common medication use and previous follow-up, only 188 (18.6%) had blood pressure <130/80 mm Hg, 517 (51.2%) had HbA1c <7.0%, and 96 (9.5%) achieved dual control. Conclusions COMPACT-HTDM enrolled a pragmatic primary care population with low baseline dual control despite established service contact. The trial will evaluate whether integrated management improves cardiometabolic control and comorbidity-oriented service delivery.