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

Обзор

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.

Подробное описание

"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."

Вмешательства

• Другое Digital Remote Management Group
  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

Первичные конечные точки

• Mean change in the patient's 10-year ASCVD risk, calculated using the China-PAR risk prediction model [Срок оценки: 12 Months]

Вторичные конечные точки (6)

• Mean change in the patient's lifetime ASCVD risk, calculated using the China-PAR risk prediction model. [Срок оценки: Baseline and 12 Months]
• Simultaneous Control Rate of Blood Pressure [Срок оценки: 12 Months]
• Mean change in SBP and DBP compared to baseline [Срок оценки: 12 Months]
• Overweight or Obesity Rate [Срок оценки: 12 Months]
• Smoking Cessation Rate [Срок оценки: 12 Months]
• Medication Adherence [Срок оценки: 12 Months]

Критерии участия

Критерии включения

• 10-year ASCVD risk ≥ 10%, calculated using the China-PAR risk prediction model
• Adultd aged ≥ 35 years
• Able to use a smartphone (or assisted by family) and agrees to remote management
• Signed informed consent

Критерии исключения

• History of acute myocardial infarction, stroke, heart failure, malignant arrhythmia, or prior percutaneous coronary intervention or coronary artery bypass grafting surgery
• Moderate to severe hepatic dysfunction (Child-Pugh class B-C)
• CKD stages 4-5 (eGFR <30 ml/min/1.73m²) or on dialysis
• Chronic obstructive pulmonary disease requiring ongoing home oxygen therapy or chronic oral steroid therapy as an outpatient
• Pregnant, planning to become pregnant within the next 12 months
• Life expectancy <12 months (e.g., advanced malignancy, etc.);
• Cognitive impairment or communication disorder.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 5 центров

• Beijing Anzhen Hospital, Capital Medical University, Beijing, China — Пекин
• The First Hospital of Jilin University, Changchun, China — Changchun
• The First Affiliated Hospital of Dalian Medical University, Dalian, China — Dalian
• The Second Affiliated Hospital of Nanchang University, Nanchang, China — Nanchang
• Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China — Шанхай

Идентификаторы

NCT: NCT07332468 · KS2025288

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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