Digital Remote Management for Care and Continuous Optimization Versus Usual Care to Reduce Risk of Atherosclerotic Cardiovascular Diseases (DigiCare-ASCVD)

N/ANot Yet RecruitingNCT07332468

Beijing Anzhen Hospital790 enrolled

Overview

The DigiCare-ASCVD study is an investigator-initiated, multicenter, open-label, parallel-group randomized controlled trial. It aims to evaluated whether digital remote management is superior to usual care in reducing risk of atherosclerotic cardiovascular diseases and improving blood pressure control, glycemic control, lipids control, medication compliance and lifestyle.

"Atherosclerotic cardiovascular disease (ASCVD) is a leading global cause of mortality. Primary care is central to its prevention within tiered healthcare systems, yet faces challenges including physician training gaps and inefficient specialist referrals. Digital remote interventions offer a promising solution due to widespread smartphone/internet access, enabling convenient care and real-time data use. Current tools focus on patient education/reminders or clinical decision support (CDSS) separately. However, effective long-term ASCVD management requires an integrated system that combines CDSS-guided treatment with comprehensive, sustained risk-factor monitoring (e.g., blood pressure, lipids). This study aims to develop and validate such an integrated remote management platform to overcome multi-level barriers, disseminate advanced resources to primary care, and enhance equitable cardiovascular risk prevention. The DigiCare-ASCVD Study is a multicenter, open-label, randomized controlled trial with a 1:1 parallel-group design. It will enroll 790 patients at high risk for ASCVD. All enrolled patients will be randomly assigned in a 1:1 ratio to either the Digital Remote Management group or the usual care group. Patients in the Digital Remote Management group will utilize a smartphone-based ""physician-machine collaboration"" platform. This system integrates home monitoring to track BP, lipids,glucose, medication compliance and physical activity. It features AI-driven alerts for abnormal values, automated medication adjustment suggestions (verified by physicians), and targeted health education The primary endpoint is the mean change in the patient's 10-year ASCVD risk, calculated using the China-PAR risk prediction model, from baseline to the 12-month follow-up."

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Conditions

Atherosclerotic Cardiovascular Diseases

Interventions

Digital Remote Management GroupOTHER

In addition to usual care, patients receive a 1-year intervention via a smartphone-based ""physician-machine collaboration"" platform： 1. BP Management: Daily or weekly self-monitoring based on control status. System triggers alerts for BP \>130/80 mmHg and generates medication adjustment suggestions for physician approval. 2. Lipid Management: Reminder for lab tests. OCR technology parses results. If LDL-C ≥2.6 mmol/L, the system suggests regimen intensification for physician review. 3. Blood Glucose Management: Reminder for lab tests. OCR technology parses results.If Fasting Blood Glucose (FBG) ≥6.1 mmol/L for patients without diabetes and FBG ≥7.0 mmol/L for patients with diabetes, the system suggests regimen intensification for physician review. 4. Medication Management: Daily app-based reminders and clock-in tasks. Non-adherence triggers automated reminders and human follow-up. 5. Health Education: Regular push of targeted articles/videos on secondary prevention。

Eligibility

Sex: ALLMin age: 35 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 10-year ASCVD risk ≥ 10%, calculated using the China-PAR risk prediction model 2. Adultd aged ≥ 35 years 3. Able to use a smartphone (or assisted by family) and agrees to remote management 4. Signed informed consent Exclusion Criteria: 1. History of acute myocardial infarction, stroke, heart failure, malignant arrhythmia, or prior percutaneous coronary intervention or coronary artery bypass grafting surgery 2. Moderate to severe hepatic dysfunction (Child-Pugh class B-C) 3. CKD stages 4-5 (eGFR \<30 ml/min/1.73m²) or on dialysis 4. Chronic obstructive pulmonary disease requiring ongoing home oxygen therapy or chronic oral steroid therapy as an outpatient 5. Pregnant, planning to become pregnant within the next 12 months 6. Life expectancy \<12 months (e.g., advanced malignancy, etc.); 7. Cognitive impairment or communication disorder.

Locations (5)

Beijing Anzhen Hospital, Capital Medical University, Beijing, China

Beijing, China

The First Hospital of Jilin University, Changchun, China

Changchun, China

The First Affiliated Hospital of Dalian Medical University, Dalian, China

Dalian, China

The Second Affiliated Hospital of Nanchang University, Nanchang, China

Nanchang, China

Outcomes

Primary Outcomes

Mean change in the patient's 10-year ASCVD risk, calculated using the China-PAR risk prediction model

Time frame: 12 Months

Secondary Outcomes

Mean change in the patient's lifetime ASCVD risk, calculated using the China-PAR risk prediction model.

Time frame: Baseline and 12 Months

Simultaneous Control Rate of Blood Pressure

SBP \< 130 mmHg, DBP \< 80 mmHg

Time frame: 12 Months

Mean change in SBP and DBP compared to baseline

Time frame: 12 Months

Overweight or Obesity Rate

Time frame: 12 Months

Smoking Cessation Rate

Self-reported complete abstinence from smoking among baseline smokers

Time frame: 12 Months

Medication Adherence

MARS-10 scale

Time frame: 12 Months

Central Contacts

Liu He

CONTACT

13810720787 theliu@139.com

Data from ClinicalTrials.gov

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