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

NCT07528391 | Not Yet Recruiting DMC

• 1 other identifier: 03002
• Study Type: interventional
• Target: 960
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants Achieving Combined Blood Pressure and Glycemic Control Using Clinic Blood Pressure Measurement and Laboratory Glycated Hemoglobin (HbA1c)

  Proportion of participants who achieve both of the following at 6 months: Blood pressure control, defined as systolic blood pressure \<130 mmHg and diastolic blood pressure \<80 mmHg, assessed by standardized seated clinic blood pressure measurement after 5 minutes of rest; and Glycemic control, defined as HbA1c \<7.0%, assessed by laboratory glycated hemoglobin testing. For blood pressure, two seated measurements are obtained after 5 minutes of rest and the average value is used for outcome assessment. The combined outcome is reported as a binary participant-level endpoint.

  Six months

Secondary Outcomes (9)

• Blood Pressure Control Rate Using Standardized Clinic Systolic and Diastolic Blood Pressure Measurement

  Six months

• Glycemic Control Rate Using Laboratory Glycated Hemoglobin (HbA1c)

  Six months

• Change in Systolic Blood Pressure Measured in Millimeters of Mercury (mmHg) by Standardized Clinic Blood Pressure Measurement

  Baseline to 6 months

• Change in Diastolic Blood Pressure Measured in Millimeters of Mercury (mmHg) by Standardized Clinic Blood Pressure Measurement

  Baseline to 6 months

• Change in Laboratory Glycated Hemoglobin (HbA1c) Percentage

  Baseline to 6 months

Study Arms (2)

Integrated Comorbidity Management Intervention

EXPERIMENTAL

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.

Behavioral: Integrated Comorbidity Management Package

Usual Care (Standard Primary Care Management)

ACTIVE COMPARATOR

Standard primary care management for hypertension and type 2 diabetes mellitus provided according to existing national guidelines.

Other: Usual Care intervention

Interventions

Integrated Comorbidity Management Package BEHAVIORAL

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.

Integrated Comorbidity Management Intervention

Usual Care intervention OTHER

Standard primary care management for hypertension and type 2 diabetes mellitus provided according to existing national guidelines.

Usual Care (Standard Primary Care Management)

Eligibility Criteria

• Age: 60 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cluster level (primary care facilities):
• Township health centers or community health service centers that provide routine primary care management services for both hypertension and diabetes.
• Agree to participate in cluster randomization and study procedures.
• Have basic capacity for chronic disease follow-up and data recording.
• Individual participant level (patients):
• Aged 60 to 74 years.
• Diagnosed with hypertension and type 2 diabetes mellitus for at least 6 months.
• Received at least one chronic disease management service at the participating study site within the past 6 months.
• Able to provide written informed consent.

You may not qualify if:

• Cluster Level (Primary Care Facilities):
• Facilities currently participating in other intervention studies or pilot programs targeting hypertension and/or diabetes management that may interfere with the study intervention.
• Facilities with major organizational instability (e.g., restructuring, closure, or significant staff turnover) that would affect implementation or follow-up.
• Individual Level:
• Severe cognitive impairment or psychiatric illness affecting participation or follow-up.
• Anticipated inability to complete 6-month follow-up.

Sponsors & Collaborators

• Xiangdong District General Hospital: collaborator
• Health Commission of Wuyuan County: collaborator
• Nanchang University: lead
• Xinfeng County Center for Disease Control and Prevention: collaborator

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Xuejun Yin, PhD

CONTACT

18600988138; xuejun.yin@ncu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 14, 2026
• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share