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

Capital Medical University

Status: Not yet enrolling

Conditions: Atherosclerotic Cardiovascular Diseases

Treatments: Other: Digital Remote Management Group

Study type: Interventional

Funder types: Other

Identifiers

NCT07332468

KS2025288

Details and patient eligibility

About

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.

Full description

"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."

Enrollment: 790 estimated patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

790 participants in 2 patient groups

Usual care Group

No Intervention group

Description:

Usual Care Group: Patients receive standard BP, lipids,glucose and physical activity management including guideline-directed medication and outpatient follow-up at 3, 6, 9, 12 months.

Digital Remote Management Group

Experimental group

Description:

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。

Treatment:

Other: Digital Remote Management Group