Comorbidity-Oriented Primary Care and Integrated Management for Hypertension and Diabetes Mellitus (COMPACT-HTDM)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension; Comorbidities and Coexisting Conditions; Diabete Type 2
• Intervention / Treatment: Behavioral: Integrated Comorbidity Management Package; Other: Usual Care intervention

• Study Type: Interventional
• Enrollment (Estimated): 960
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xuejun Yin, PhD; Phone Number: 18600988138; Email: xuejun.yin@ncu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Integrated Comorbidity Management Intervention; 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; 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.
Active Comparator: Usual Care (Standard Primary Care Management); Standard primary care management for hypertension and type 2 diabetes mellitus provided according to existing national guidelines.	Other: Usual Care intervention; Standard primary care management for hypertension and type 2 diabetes mellitus provided according to existing national guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Six months
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.	Six months
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.	Baseline to 6 months
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.	Baseline to 6 months
Change in Laboratory Glycated Hemoglobin (HbA1c) Percentage	Change in HbA1c from baseline to 6 months, assessed by laboratory glycated hemoglobin testing. Unit of measure: percent (%). Lower values indicate better glycemic control.	Baseline to 6 months
Medication Adherence Assessed by the Adherence to Refills and Medications Scale (ARMS)	Medication adherence is assessed using the Adherence to Refills and Medications Scale (ARMS) included in the questionnaire. The ARMS contains 12 items, each scored from 1 to 4, for a total score range of 12 to 48. Lower scores indicate better medication adherence and higher scores indicate worse adherence. The questionnaire assesses medication-taking and prescription refill behaviors over the past 3 months.	6 months
Physical Activity Assessed by the International Physical Activity Questionnaire (IPAQ)	Physical activity is assessed using the International Physical Activity Questionnaire (IPAQ) items in the questionnaire, including vigorous activity, moderate activity, walking, and sitting time over the last 7 days. The primary reported value will be total physical activity in MET-minutes/week, calculated from frequency and duration of vigorous activity, moderate activity, and walking. Higher MET-minutes/week indicate greater physical activity. Sitting time may be summarized separately in minutes/day if reported descriptively.	Baseline to 6 months
Incidence of Hypoglycemia Assessed by Participant Report and Medical Record Review	Incidence of hypoglycemia events during the intervention period, identified by participant report and/or medical record review. Reported as the proportion of participants with at least one hypoglycemia event.	During the 6-month intervention period
Incidence of Hypotension Assessed by Participant Report and Medical Record Review	Incidence of hypotension events during the intervention period, identified by participant report and/or medical record review. Reported as the proportion of participants with at least one hypotension event.	During the 6-month intervention period

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: April 1, 2026
• First Submitted That Met QC Criteria: April 7, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Hypertension; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 03002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No