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

Official title

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

Overview

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.

Interventions

• 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, weigh
• Other Usual Care intervention
  Standard primary care management for hypertension and type 2 diabetes mellitus provided according to existing national guidelines.

Primary outcome measures

• Proportion of Participants Achieving Combined Blood Pressure and Glycemic Control Using Clinic Blood Pressure Measurement and Laboratory Glycated Hemoglobin (HbA1c) [Time frame: Six months]

Secondary outcome measures (9)

• Blood Pressure Control Rate Using Standardized Clinic Systolic and Diastolic Blood Pressure Measurement [Time frame: Six months]
• Glycemic Control Rate Using Laboratory Glycated Hemoglobin (HbA1c) [Time frame: Six months]
• Change in Systolic Blood Pressure Measured in Millimeters of Mercury (mmHg) by Standardized Clinic Blood Pressure Measurement [Time frame: Baseline to 6 months]
• Change in Diastolic Blood Pressure Measured in Millimeters of Mercury (mmHg) by Standardized Clinic Blood Pressure Measurement [Time frame: Baseline to 6 months]
• Change in Laboratory Glycated Hemoglobin (HbA1c) Percentage [Time frame: Baseline to 6 months]
• Medication Adherence Assessed by the Adherence to Refills and Medications Scale (ARMS) [Time frame: 6 months]
• Physical Activity Assessed by the International Physical Activity Questionnaire (IPAQ) [Time frame: Baseline to 6 months]
• Incidence of Hypoglycemia Assessed by Participant Report and Medical Record Review [Time frame: During the 6-month intervention period]
• Incidence of Hypotension Assessed by Participant Report and Medical Record Review [Time frame: During the 6-month intervention period]

Eligibility criteria

Inclusion criteria

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.

Exclusion criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Health services research

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07528391 · 03002

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗