Implementation of Machine Learning and Hemodynamic Profiles Based Clinical Decision Support Systems for Personalized Guideline Accordant Antihypertensive Regimens in Primary Care: a Pragmatic Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,160
- 试验地点
- 1
- 主要终点
- hierarchical composite outcome
研究概览
简要总结
This trial is a prospective, multicenter, single-blind, three-arm parallel-group, cluster randomized controlled trial assessing the effectiveness and safety of two types of CDSS in primary care settings in China. Primary care sites are randomized to one of the intervention arms or the control arm (1:1:1 ratio) using computer-generated random numbers stratified by region and administrative categories of the primary healthcare institutions (including community health centers, community health stations, and township health centers). A total of 51 primary care sites are randomized to three groups, with 17 sites assigned to group A (use a CDSS based on clinical guidelines and machine learning), 17 sites to group B (use a CDSS based on guidelines, hemodynamic parameters and ML), and the remaining 17 sites to the control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 35 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •35 ≤ Age < 80 years.
- •Regularly attend the clinic for hypertension treatment during the study period, without plans of traveling during the study period.
- •Diagnosed with hypertension, with SBP ≥140mmHg at screening.
- •Currently taking 0 or 2 classes of antihypertensive medications (A/C/D), with or without concurrent use of class B.
- •Willing to participate in the trial and capable of providing written informed consent.
排除标准
- •Physician-diagnosed or suspected secondary hypertension (e.g., hypertension caused by renal disease, renal artery stenosis, aortic stenosis, primary aldosteronism, pheochromocytoma/paraganglioma, Cushing's syndrome, thyroid dysfunction, intracranial disease, drug-induced, or rare monogenic genetic disease).
- •SBP ≥180mmHg and/or DBP ≥110mmHg at the screening visit.
- •Suspected or diagnosed white coat hypertension.
- •History of coronary heart disease.
- •History of heart failure.
- •Intolerance to 2 or more classes of A, C,D antihypertensive medications.
- •Currently taking antihypertensive medications other than class A,B,C and D.
- •Diagnosed chronic kidney disease, estimating Glomerular Filtration Rate (eGFR)< 60 ml/min·1.73m2, or receiving dialysis.
- •Serious medical conditions (e.g., malignant cancer and hepatic dysfunction)
- •Currently in an acute episode of disease (e.g, new-onset cardiovascular and cerebrovascular disease occurred within 3 months).
- •Cognitive or communicative disorders.
- •Currently pregnant or breastfeeding or planning a pregnant or breastfeeding during the study.
- •Reluctant to take antihypertensive medications or have poor compliance with previous treatment.
- •Participating in other clinical trials.
研究组 & 干预措施
Group C (UC)
干预措施: Group C (usual care) (Other)
Group A (CG+ML)
干预措施: Group A (clinical guideline+machine learning) (Combination Product)
Group B (CG+ICG+ML)
干预措施: Group B (clinical guideline+impedance cardiograph+machine learning) (Combination Product)
结局指标
主要结局
hierarchical composite outcome
时间窗: Baseline; 3 months
The primary outcome of the trial is a hierarchical composite outcome, evaluated using the Win-ratio method in the following order: 1. Office blood pressure control rate (\<130/80 mmHg) at 3 months after randomization. 2. The duration from baseline to the first occurrence of controlled blood pressure achievement (\<130/80 mmHg) within 3 months after randomization. 3. The composite index of the number and dosage of antihypertensive drugs among participants achieved controlled blood pressure at 3 months after randomization.
次要结局
- Changes in office systolic and diastolic blood pressure from baseline to 1 month and 3 months(Baseline; 1 month; 3 months)
- Average 24-hour ambulatory systolic and diastolic blood pressure, along with blood pressure control rate at 3 months(3 months)
- Changes in hemodynamic parameters measured by ICG from baseline to 3 months(Baseline; 3 months)
- Differences in the three-tier hierarchical composite primary outcomes and each component of the three-tier hierarchical composite primary outcome among intervention groups at 3 months(Baseline; 3 months)
- Separate evaluation of each component of the three-tier hierarchical composite primary outcome at 3 months(Baseline; 3 months)