Comorbidity-Oriented Primary Care and Integrated Management for Hypertension and Diabetes Mellitus: A Cluster Randomised Controlled Trial in Rural China
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 960
- 主要终点
- Proportion of Participants Achieving Combined Blood Pressure and Glycemic Control Using Clinic Blood Pressure Measurement and Laboratory Glycated Hemoglobin (HbA1c)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Usual Care (Standard Primary Care Management)
Standard primary care management for hypertension and type 2 diabetes mellitus provided according to existing national guidelines.
干预措施: Usual Care intervention (Other)
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.
干预措施: Integrated Comorbidity Management Package (Behavioral)
结局指标
主要结局
Proportion of Participants Achieving Combined Blood Pressure and Glycemic Control Using Clinic Blood Pressure Measurement and Laboratory Glycated Hemoglobin (HbA1c)
时间窗: Six months
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.
次要结局
- 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)
- Medication Adherence Assessed by the Adherence to Refills and Medications Scale (ARMS)(6 months)
- Physical Activity Assessed by the International Physical Activity Questionnaire (IPAQ)(Baseline to 6 months)
- Incidence of Hypoglycemia Assessed by Participant Report and Medical Record Review(During the 6-month intervention period)
- Incidence of Hypotension Assessed by Participant Report and Medical Record Review(During the 6-month intervention period)
研究者
Xuejun Yin
Professor
Nanchang University