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| Name | Class |
|---|---|
| Xiangdong District General Hospital | UNKNOWN |
| Xinfeng County Center for Disease Control and Prevention | UNKNOWN |
| Health Commission of Wuyuan County | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Cluster level (primary care facilities):
Individual participant level (patients):
Exclusion Criteria:
Cluster Level (Primary Care Facilities):
Individual Level:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xuejun Yin, PhD | Contact | 18600988138 | xuejun.yin@ncu.edu.cn |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
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| Usual Care intervention | Other | Standard primary care management for hypertension and type 2 diabetes mellitus provided according to existing national guidelines. |
|
| 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 |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |