County Medical Community-based, Cardiovascular Risk Stratified Integrated Care Model: a Pragmatic Cluster Randomised Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,560
- 试验地点
- 3
- 主要终点
- 10-year CVD risk score
研究概览
简要总结
The goal of this cluster randomized trial is to evaluate the effectiveness of the RISIMA model based on an integrated county healthcare consortium implemented by multi-level family health teams (FHTs)on patients with diabetes and/or hypertension, including CVD risk assessment, treatment, and management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The follow-up data collection, data entry, and data quality checks will be conducted by researchers unaware of the group assignments. The analysis of results will also be performed by statisticians unaware of the allocation.
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 40 and 70 years old;
- •Patients with hypertension or diabetes;
- •Permanent residents of the county where the research is conducted;
- •Already signed up with the family doctor team in the township where the research is located.
排除标准
- •Unable to independently carry out the interventions required for the study;
- •Residing far from the village or township health center where the research is located, making it difficult to cooperate with visits;
- •Patients who refuse to participate;
- •Patients with comorbidities such as cancer that may interfere with the study visits or intervention effects;
- •Pregnant or lactating women
研究组 & 干预措施
Control
During the study, control participant will be provided with existing essential public health service including quarterly follow-ups and annual physical examination, and be advised to see their usual provider for care, as appropriate.
Intervention
Intervention group will receive the risk-stratified integrated CVD management (RISIMA) model consisting of 5 core elements provided as a package: (1) Team-based care; (2) Risk-stratified care pathway; (3) Strengthened health education; (4) Financial incentives for integration of care; (5) Supporting health information system.
干预措施: Financial incentives for integration of care (Other)
Intervention
Intervention group will receive the risk-stratified integrated CVD management (RISIMA) model consisting of 5 core elements provided as a package: (1) Team-based care; (2) Risk-stratified care pathway; (3) Strengthened health education; (4) Financial incentives for integration of care; (5) Supporting health information system.
干预措施: Strengthened health education (Behavioral)
Intervention
Intervention group will receive the risk-stratified integrated CVD management (RISIMA) model consisting of 5 core elements provided as a package: (1) Team-based care; (2) Risk-stratified care pathway; (3) Strengthened health education; (4) Financial incentives for integration of care; (5) Supporting health information system.
干预措施: Team-based care (Other)
Intervention
Intervention group will receive the risk-stratified integrated CVD management (RISIMA) model consisting of 5 core elements provided as a package: (1) Team-based care; (2) Risk-stratified care pathway; (3) Strengthened health education; (4) Financial incentives for integration of care; (5) Supporting health information system.
干预措施: Risk-stratified care pathway (Procedure)
Intervention
Intervention group will receive the risk-stratified integrated CVD management (RISIMA) model consisting of 5 core elements provided as a package: (1) Team-based care; (2) Risk-stratified care pathway; (3) Strengthened health education; (4) Financial incentives for integration of care; (5) Supporting health information system.
干预措施: Supporting health information system (Other)
结局指标
主要结局
10-year CVD risk score
时间窗: 12 months
This study intervention is designed to address CVD risk by introducing an integrated care package. Therefore, a validated risk score is required to properly evaluate the effect of interventions. The WHO/ISH score is a tool to estimate the risk of CVD development based on age, sex, BP, total cholesterol, smoking and diabetes. The primary objective of this study is to evaluate whether or not the intervention can substantially lower the risk at 1 year. The primary outcome is the mean difference in WHO/ISH risk score change from baseline to 12 months between the intervention and control townships. The WHO/ISH risk score will be calculated using the lab-based measurements, but if there are missing, a nonlaboratory measurements will be used.
次要结局
- CVD incidence rate(12 months)
- systolic blood pressure(12 months)
- total cholesterol(12 months)
- 10-year CVD risk score changes(6 months)
- blood pressure control rate(12 months)
- systolic blood pressure(6 months)
- total cholesterol(12 months)
- fasting blood glucose(12 months)
- CVD incidence rate(12 months)
- cost-effectiveness outcome(12 months)