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

NCT07588256 | Recruiting DMC

• 1 other identifier: T888-DIGICARE-DREAM
• Study Type: interventional
• Target: 4,162
• Locations: 1 country
• Sites: 1

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.

Conditions

Microalbuminuria; Microalbuminuria /Creatinine Ratios ACR; Cardiovascular Disease Risk Factor; Digital Medicine; Hypertension; Cardiovascular Disease Prevention; Hyperglycaemia (Diabetic); Hyperlipidemia

Keywords

digital medicine; hypertension; home blood pressure monitoring; dyslipidemia; microalbuminuria; diabetes

Outcome Measures

Primary Outcomes (7)

• Mean home blood pressure <130/80 mmHg.

  T-888-DIGICARE study

  24 months from baseline

• LDL-C <100 mg/dL (and <70 mg/dL for patients with diabetes or ASCVD).

  T-888-DIGICARE study

  24 months from baseline

• HbA1c <6.5% or a reduction of at least 1% from baseline if baseline HbA1c >8% or at least 2% if baseline HbA1c >10%.

  T-888-DIGICARE study

  24 months from base line

• ≥30% reduction in urine albumin to creatinine ratio (UACR).

  T-888-DIGICARE study

  24 months from baseline

• Improvement in target organ damage (changes in left ventricular mass by AI ECG and in retinal vascular lesions).

  T-888-DIGICARE study

  24 months from baseline

• • Morning home systolic and diastolic blood pressure at 6 months.

  DREAM-G study

  6 months

• • Change in UACR from baseline to 6 months, as a marker of renal target organ protection.

  DREAM-G study

  6 months

Study Arms (4)

Standard care

NO INTERVENTION

with a mobile digital health platform but no interactive digital modules

bedtime dosing

EXPERIMENTAL

Selective nocturnal antihypertensive dosing

Behavioral: Antihypertensive Medication Management

Conventional morning dosing

NO INTERVENTION

Universal morning antihypertensive dosing

Degital care

EXPERIMENTAL

With a mobile digital health platform augmented with interactive digital modules

Behavioral: Interactive digital modules

Interventions

Interactive digital modules BEHAVIORAL

Whether the Mobile Digital Health Platform augmented with interactive digital modules improves control rates of the Three Highs (Hypertension, Hyperglycemia, Hyperlipidemia), target organ damages and cardiovascular outcomes

Degital care

Antihypertensive Medication Management BEHAVIORAL

Therapeutic effects of selective nocturnal versus universal morning antihypertensive dosing on morning home blood pressure control and target organ damages

bedtime dosing

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• I.T-888-DIGICARE：
• Eligible participants must meet the definition of hypertension and at least one of the following chronic (non-hypertensive) conditions:
• 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
• Hyperlipidemia
• With or without treatment, and
• LDL-C \>100 mg/dL (or \>70 mg/dL in patients with diabetes or established ASCVD)
• Diabetes Mellitus
• With or without treatment, and
• HbA1c \>6.5%
• 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

You may not qualify if:

• I. T-888-DIGICARE
• Symptomatic heart failure (New York Heart Association functional class II-IV)
• End-stage renal disease requiring long-term dialysis
• Pregnant women or those planning pregnancy
• II. DREAM-G:
• Life expectancy \<1 year
• End-stage renal disease (ESRD) requiring regular renal replacement therapy, including dialysis, kidney transplantation, or palliative care
• Severe liver cirrhosis
• Malignancy under active treatment

Sponsors & Collaborators

• New Taipei City Medical Association: lead
• National Taiwan University: collaborator

Study Sites (1)

United safety medical group(USMG)

New Taipei City, Taiwan

RECRUITING

MeSH Terms

Conditions

Hypertension; Hyperglycemia; Hyperlipidemias; Dyslipidemias; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Lipid Metabolism Disorders; Endocrine System Diseases

Central Study Contacts

Hung-Shun Yen Principal Investigator

CONTACT

886-22994-2075; usmg@usmg.com.tw

Tzung-Dau Wang Co-Principal Investigator

CONTACT

tdwang@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 14, 2026
• Study Start: February 5, 2026
• Primary Completion (Estimated): February 5, 2029
• Study Completion (Estimated): February 5, 2029
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)