NCT07588256 New Taipei City 888 Digital Medical AI Platform for Prevention and Care of the Three Highs and Cardio-Renal-Vascular Diseases

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This trial targets 4,162 participants in total. It began in 2026-02-05 with a primary completion date of 2029-02-05.

Brief Summary

Non-communicable diseases (NCDs), or chronic diseases, are a major public health burden globally and in Taiwan, and control of the "three highs" (hypertension, dyslipidemia, and hyperglycemia) is a national priority. Nearly half of the 10 leading causes of death in Taiwan are directly or indirectly related to atherosclerotic cardiovascular disease (ASCVD), for which hypertension, dyslipidemia, and abnormal blood glucose are the major risk factors. National health insurance data indicate that over 70% of middle-aged and older adults have at least one of these chronic conditions. Early stages are often asymptomatic, and inadequate control may lead to complications of cardiovascular disease, stroke, renal vascular disease, and retinopathy, causing irreversible organ damage and death. For blood pressure, large clinical trials such as SPRINT and STEP have shown that targeting systolic blood pressure below 130 mmHg significantly reduces ASCVD events. For LDL cholesterol, "the lower, the better" applies, with guideline-recommended LDL-C targets determined by baseline ASCVD risk, with levels below 55 mg/dL for very high-risk patients. For diabetes, treatment goals generally include fasting plasma glucose below 130 mg/dL and glycated hemoglobin (HbA1c) below 7%. Although antihypertensive therapy has been proven effective in preventing cardiovascular disease and chronic kidney disease attributable to hypertension, fewer than one-third of patients receiving antihypertensive medications achieve current guideline-recommended blood pressure targets. No randomized clinical trial to date has used home blood pressure as the primary therapeutic reference. Moreover, long-term evidence is lacking regarding the organ-protective effects of strategies targeting morning hypertension and of bedtime dosing regimens. Although the TIME study is currently the largest and longest-followed trial addressing dosing time, its bedtime-dosing arm was not specifically targeted to patients with morning hypertension. Therefore, we propose a clinical trial to investigate management strategies for morning hypertension. Aligned with the 2022 Taiwan Hypertension Guidelines, we will employ the "722 protocol" for home blood pressure monitoring and enroll patients with morning home blood pressure ≥130/80 mmHg to compare selective nocturnal administration of antihypertensive agents versus exclusive morning dosing, assessing differences in morning home blood pressure control rates, end-organ damage, and atherosclerotic cardiovascular disease (ASCVD) events. This project will implement two large-scale cluster-randomized clinical trials within the New Taipei City healthcare network. The first trial (T-888-DIGICARE) will evaluate whether a mobile digital health platform augmented with interactive digital modules can more effectively achieve the "888" targets for prevention and treatment of the Three Highs (Hypertension, Hyperglycemia, Hyperlipidemia). The second trial (DREAM-G) will use the same mobile health delivery model to investigate whether the timing of antihypertensive medication administration (nocturnal versus morning dosing) differentially affects patients with poor morning home blood pressure control. Beyond generating rigorous evidence through a novel clinical approach, this program is expected to have substantial global clinical impact and to showcase Taiwan's healthcare capabilities internationally. Operational challenges encountered and solutions developed during the trials will also provide critical feasibility data for the concurrent real-world implementation registry (T-888-DIGICARE-Registry). The registry will run in parallel with the cluster trials and will enroll individuals who decline trial participation at baseline as well as participants after trial completion, thereby serving as a continuity and real-world evidence platform.

Eligibility 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

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