Health TrialsbyHealthPanel

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

ConditionsHypertensionDiabete Type 2Comorbidities and Coexisting Conditions
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-74
SponsorNanchang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Aged 60 to 74 years.

Disqualifiers

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.

Severe cognitive impairment or psychiatric illness affecting participation or follow-up.

Anticipated inability to complete 6-month follow-up.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Usual Care intervention

    Other intervention

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

Treatment groups

960 Participants
are divided into 2 treatment groups
Group A: Integrated Comorbidity Management InterventionExperimental treatment 1 intervention
Group B: Usual Care (Standard Primary Care Management)Active comparator 1 intervention

Trial outcomes

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.

Time frame
Six months

Secondary outcomes

1

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

Proportion of participants with systolic blood pressure \<130 mmHg and diastolic blood pressure \<80 mmHg at 6 months, assessed using standardized seated clinic blood pressure measurement after 5 minutes of rest. Two measurements are taken and the average is used. Unit of measure: mmHg.

Time frame
Six months
2

Glycemic Control Rate Using Laboratory Glycated Hemoglobin (HbA1c)

Proportion of participants with HbA1c \<7.0% at 6 months, assessed by laboratory glycated hemoglobin testing. Unit of measure: percent (%). Lower values indicate better glycemic control.

Time frame
Six months
3

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

Change in systolic blood pressure from baseline to 6 months, assessed by standardized seated clinic blood pressure measurement after 5 minutes of rest. Two measurements are taken and the average systolic blood pressure is used. Unit of measure: mmHg.

Time frame
Baseline to 6 months
4

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

Change in diastolic blood pressure from baseline to 6 months, assessed by standardized seated clinic blood pressure measurement after 5 minutes of rest. Two measurements are taken and the average diastolic blood pressure is used. Unit of measure: mmHg.

Time frame
Baseline to 6 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nanchang University

Lead sponsor

Xiangdong District General Hospital

Collaborator

Xinfeng County Center for Disease Control and Prevention

Collaborator

Health Commission of Wuyuan County

Collaborator

Source ClinicalTrials.gov

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