Status
Conditions
Treatments
About
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.
Full description
Participants identified through the 888 screening program with at least one abnormal value will be invited for group allocation. Home blood pressure measurement will be performed according to the "722 protocol." If morning home BP ≥130/80 mmHg (average home BP ≥130/80 mmHg or already receiving antihypertensive therapy), participants will be invited to join the randomized clinical trial DREAM-G, investigating optimal timing of antihypertensive medication for morning hypertension. All other participants will be invited to the randomized clinical trial T-888-DIGICARE, evaluating care intervention via a mobile smart healthcare platform. Those not enrolled will be invited to participate in the pragmatic digital health registry program T-888-DIGICARE-Registry.
Execution methods and procedures for these three large-scale clinical trials are as follows:
Randomized Clinical Trial of Mobile Smart Healthcare Platform Intervention (T-888-DIGICARE)
Randomization Unit: Participating primary care clinics. Each clinic must complete informed consent and enrollment preparation prior to participation.
Randomization Method: Computer-generated block randomization, stratified by clinic location. Stratification is based on the median household disposable income across the 29 administrative districts of New Taipei City, categorized into three socioeconomic tiers. Clinics are randomized within each tier to minimize confounding by socioeconomic status on health behaviors and healthcare accessibility, and to facilitate future policy expansion in lower-income regions.
• Given the practical nature of digital platform implementation, blinding of physicians and patients is not feasible. Therefore, a single-blind design is adopted: investigators responsible for data aggregation and statistical analysis of primary and secondary endpoints remain blinded to clinic allocation, reducing analytic bias.
Intervention Measures:
Pragmatic Digital Health Registry Program (T-888-DIGICARE-Registry)
Blood Pressure Intervention Logic (per 2022 Taiwan Hypertension Guidelines):
Lipid Intervention Logic (per 2022 Taiwan Dyslipidemia Guidelines):
Glycemic Intervention Logic (per ADA Guidelines):
Lifestyle Intervention:
Patient Interaction Mechanisms:
Randomized Clinical Trial on Optimal Timing of Antihypertensive Medication for Morning Hypertension (DREAM-G)
Adjustment principles:
Principles of Antihypertensive Medication Adjustment:
Treated HTN Untreated HTN Average Home BP Monitoring (HBPM) HBPM < 130/80 mmHg HBPM ≥ 130/80 mmHg HBPM ≥ 130/80 mmHg Morning Home BP Monitoring (HBPM) HBPM ≥ 130/80 mmHg HBPM ≥ 130/80 mmHg HBPM ≥ 130/80 mmHg Intervention Group Shift one antihypertensive agent from daytime to bedtime dosing Initiate a new antihypertensive agent at bedtime, or adjust the dosage of existing medication Initiate a new antihypertensive agent at bedtime Control Group No dosage adjustment required Initiate a new antihypertensive agent during the daytime, or adjust the dosage of existing medication Initiate a new antihypertensive agent during the daytime
Clinical Assessments:
Enrollment
Sex
Volunteers
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:
Hypertension
Hyperlipidemia
Diabetes Mellitus
Chronic Kidney Disease (CKD)
Atherosclerotic Cardiovascular Disease (ASCVD):
II. DREAM-G:
Hypertension
Hyperlipidemia
Diabetes Mellitus
Chronic Kidney Disease (CKD)
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:
Untreated Hypertension:
Treated Hypertension:
Exclusion criteria
I. T-888-DIGICARE
II. DREAM-G:
Primary purpose
Allocation
Interventional model
Masking
4,162 participants in 4 patient groups
Loading...
Central trial contact
Tzung-Dau Wang Co-Principal Investigator; Hung-Shun Yen Principal Investigator
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal