Digital health platform to help prevent and manage high blood pressure, lipids, and kidney and heart disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This program uses a mobile smart healthcare platform to deliver interactive digital modules and antihypertensive medication management for adults with hypertension and related risk factors. Participants are recruited from primary care clinics and randomized within clinic sites, with randomization stratified by socioeconomic tier to reduce bias. The study follows a three-arm approach: a DREAM-G trial for morning- timing of antihypertensive therapy, a T-888-DIGICARE trial of digital care interventions, and a registry for those not enrolled. Home blood pressure will be recorded according to a standardized protocol, and eligibility includes adults with hypertension and at least one additional condition such as hyperlipidemia, diabetes, CKD, or ASCVD. The overarching goal is to determine whether digital interventions can improve cardiovascular and renal risk markers in a real-world setting.

Why it matters

Who can join: the full rules

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

Where it's running

• United safety medical group(USMG)
  New Taipei City, Taiwan Recruiting

Study contacts

• Study coordinator: Hung-Shun Yen Principal Investigator
• Email: usmg@usmg.com.tw
• Phone: 886-22994-2075

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.