Atherosclerotic Cardiovascular Diseases
Conditions
Brief summary
The DigiCare-preASCVD 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.
Detailed 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 564 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."
Interventions
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。
Sponsors
Beijing Anzhen Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in the patient's 10-year ASCVD risk, calculated using the China-PAR risk prediction model | From Baseline to 12 Months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Control Rate of Systolic Blood Pressure (SBP) | 12 Months | SBP \< 130 mmHg at 12 months |
| Control Rate of Diastolic Blood Pressure (DBP) | 12 Months | DBP \< 80 mmHg at 12 months |
| Mean change in SBP compared to baseline | From Baseline to 12 Months | — |
| Mean change in DBP compared to baseline | From Baseline to 12 Months | — |
| Mean change in fasting blood glucose compared to baseline | From Baseline to 12 Months | — |
| Mean change in low-density lipoprotein compared to baseline | From Baseline to 12 Months | — |
| Overweight or Obesity Rate compared to Baseline | From Baseline to 12 Months | — |
| Current Smoking Rate compared to Baseline | From Baseline to 12 Months | — |
Countries
China
Contacts
CONTACTLiu He
Outcome results
None listed