New Taipei City 888 Digital Medical AI Platform for the Prevention and Treatment of the Three Highs (Hypertension, Hyperglycemia, Hyperlipidemia) and Cardio-Renal-Vascular Diseases: Validation and Implementation Through Large-Scale Cluster Randomized Clinical Trials: T-888-DIGICARE-DREAM
Sponsor: New Taipei City Medical Association
Trial Details
| Condition | Microalbuminuria, Microalbuminuria /Creatinine Ratios ACR, Cardiovascular Disease Risk Factor, Cardiovascular Disease Prevention, Digital Medicine, Hypertension, Hyperglycaemia (Diabetic), Hyperlipidemia |
| Intervention | Interactive digital modules; Antihypertensive Medication Management |
| Phase | NA |
| Status | Recruiting |
| Participants | 4,162 |
| Est. Completion | 5 Feb 2029 |
| Last Updated | 14 May 2026 |
Primary Outcome
Mean home blood pressure <130/80 mmHg.; LDL-C <100 mg/dL (and <70 mg/dL for patients with diabetes or ASCVD).; HbA1c <6.5% or a reduction of at least 1% from baseline if baseline HbA1c >8% or at least 2% if baseline HbA1c >10%.; ≥30% reduction in urine albumin to creatinine ratio (UACR).; Improvement in target organ damage (changes in left ventricular mass by AI ECG and in retinal vascular lesions).; • Morning home systolic and diastolic blood pressure at 6 months.; • Change in UACR from baseline to 6 months, as a marker of renal target organ protection.
Eligibility Criteria
Inclusion Criteria
Inclusion Criteria: I.T-888-DIGICARE: Eligible participants must meet the definition of hypertension and at least one of the following chronic (non-hypertensive) conditions: 1. Hypertension * With or without treatment, and meeting one of the following: * Office blood pressure: two consecutive measurements \>130/80 mmHg * Home blood pressure: weekly average (morning/evening) \>130/80 mmHg, or more than half of the weekly measurements exceeding this threshold 2. Hyperlipidemia * With or without treatment, and * LDL-C \>100 mg/dL (or \>70 mg/dL in patients with diabetes or established ASCVD) 3. Diabetes Mellitus * With or without treatment, and * HbA1c \>6.5% 4. Chronic Kidney Disease (CKD) * Estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m², and * Urine albumin-to-creatinine ratio (UACR) \>30 mg/g 5. Atherosclerotic Cardiovascular Disease (ASCVD): * Including coronary artery disease, cerebrovascular disease, peripheral arterial disease, or aortic pathology II. DREAM-G: 1. Hypertension * With or without treatment, and meeting one of the following: * Office blood pressure: two consecutive measurements \>130/80 mmHg * Home blood pressure: weekly average (morning/evening) \>130/80 mmHg, or more than half of weekly measurements exceeding this threshold 2. Hyperlipidemia * With or without treatment, and * LDL-C \>100 mg/dL (or \>70 mg/dL in patients with diabetes or established ASCVD) 3. Diabetes Mellitus * With or without treatment, and * HbA1c \>6.5% 4. Chronic Kidney Disease (CKD) * Estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m², and * Measurable urinary microalbumin-to-creatinine ratio 5. Atherosclerotic Cardiovascular Disease (ASCVD): • Including coronary artery disease, cerebrovascular disease, peripheral arterial disease, or aortic pathology Participants must meet at least one of the above chronic disease conditions and: 6. Untreated Hypertension: * Morning home blood pressure (HBP) \>130/80 mmHg: weekly average (≥4 days) \>130/80 mmHg, * Or more than half of morning HBP measurements (≥4 days per week) \>130/80 mmHg 7. Treated Hypertension: * Morning home blood pressure \>130/80 mmHg: weekly average (≥4 days) \>130/80 mmHg, * Or more than half of morning HBP measurements (≥4 days per week) \>130/80 mmHg * Average home blood pressure ≤130/80 mmHg (used to determine treatment strategy) Exclusion Criteria: I. T-888-DIGICARE 1. Symptomatic heart failure (New York Heart Association functional class II-IV) 2. End-stage renal disease requiring long-term dialysis 3. Pregnant women or those planning pregnancy II. DREAM-G: 1. Life expectancy \<1 year 2. End-stage renal disease (ESRD) requiring regular renal replacement therapy, including dialysis, kidney transplantation, or palliative care 3. Severe liver cirrhosis 4. Malignancy under active treatment
Trial Sites
Countries
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