NCT07528391

Comorbidity-Oriented Primary Care and Integrated Management for Hypertension and Diabetes Mellitus

Comorbidity-Oriented Primary Care and Integrated Management for Hypertension and Diabetes Mellitus: A Cluster Randomised Controlled Trial in Rural China

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 960 (estimated)
• Sponsor: Nanchang University · Academic / Other
• Sex: All
• Age: 60 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

The COMPACT-HTDM study is a parallel, two-arm cluster randomized controlled trial designed to evaluate a comorbidity-oriented integrated primary care management model for elderly patients with coexisting hypertension and type 2 diabetes mellitus in community health centers and township health centers. The trial aims to determine whether an integrated comorbidity management package can improve metabolic control and cardiovascular risk management compared with usual disease-specific care in routine primary care settings. Clusters are primary care facilities randomized 1:1 to intervention or control by an independent statistician using a computer-generated random sequence. Patients aged 60-74 years with diagnosed hypertension and type 2 diabetes for at least six months and recent use of chronic disease management services at the study site will be recruited through chronic disease registries. The intervention includes comorbidity-focused medication optimization and safety management, integrated lifestyle management, self-management and community support, training for primary care staff, standardized toolkits and workflow embedding, an integrated comorbidity management platform, and feedback/incentive mechanisms. The control group will continue current standard primary care management for hypertension and diabetes under existing national guidelines. Participants will be followed for six months, with possible extension to 12 months for longer-term outcomes. The primary outcome is the proportion of participants achieving both blood pressure and glycemic control targets, defined as SBP/DBP \<130/80 mmHg and HbA1c \<7.0%. Secondary outcomes include BMI, blood lipids, medication adherence, lifestyle behaviors, follow-up completion, referral rate, and safety events such as hypoglycemia and hypotension; implementation outcomes include acceptability, fidelity, and feasibility.

Conditions

• Hypertension
• Diabete Type 2
• Comorbidities and Coexisting Conditions

Interventions

Type	Name	Description
BEHAVIORAL	Integrated Comorbidity Management Package	The intervention is a multi-component, comorbidity-oriented integrated management package for patients with coexisting hypertension and type 2 diabetes mellitus delivered at the primary care level. It includes: (1) standardized assessment and risk stratification for combined cardiometabolic risk; (2) coordinated medication management and optimization for blood pressure and glycemic control, including safety monitoring; (3) integrated lifestyle modification support (diet, physical activity, weight management, and smoking cessation); (4) structured self-management education and community-based support; (5) training and capacity building for primary care providers; (6) use of standardized clinical pathways, toolkits, and digital support systems to facilitate integrated care delivery; and (7) regular follow-up, monitoring, and feedback with performance evaluation and quality improvement mechanisms.
OTHER	Usual Care intervention	Standard primary care management for hypertension and type 2 diabetes mellitus provided according to existing national guidelines.

Timeline

• Start date: 2026-05-01
• Primary completion: 2027-04-30
• Completion: 2028-12-31
• First posted: 2026-04-14
• Last updated: 2026-04-14