RecruitingNANCT07588256

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

ConditionMicroalbuminuria, Microalbuminuria /Creatinine Ratios ACR, Cardiovascular Disease Risk Factor, Cardiovascular Disease Prevention, Digital Medicine, Hypertension, Hyperglycaemia (Diabetic), Hyperlipidemia
InterventionInteractive digital modules; Antihypertensive Medication Management
PhaseNA
StatusRecruiting
Participants4,162
Est. Completion5 Feb 2029
Last Updated14 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

Taiwan
View Registry Entry

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