An interventional study of Hybrid AI-Enabled Out-of-Hospital Health Management and Standard Out-of-Hospital Guidance in Hypertension, Hyperglycemia and Dyslipidemia, sponsored by China National Center for Cardiovascular Diseases. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by China National Center for Cardiovascular Diseases · Not applicable, Interventional, and Treatment
High blood pressure often occurs together with abnormal blood glucose, abnormal blood lipids, or abdominal obesity. Managing these conditions outside the hospital can be difficult. This study will test whether a digital health program that combines artificial intelligence (AI) with review and support by doctors and nurses improves health outcomes compared with standard out-of-hospital guidance.
The study will enroll 150 adults aged 18 to 70 years who have hypertension and at least one additional cardiometabolic risk factor that is not at target. Participants will be randomly assigned in a 1:1 ratio to either the hybrid AI-assisted management group or the standard-guidance group. The intervention group will use a patient mini-program and connected devices to monitor blood pressure, glucose, and lifestyle information. The AI system will propose personalized medication, diet, exercise, and monitoring plans, which the healthcare team will review and confirm before delivery. The control group will receive routine printed health education and usual clinical follow-up.
All participants will be followed for 6 months. The main outcome is the proportion of participants achieving blood pressure control together with control of at least one glycemic or lipid indicator. Other assessments include treatment adherence, cardiovascular events, hospitalizations, medical costs, quality of life, and system usability.
This single-center, prospective, randomized, open-label, parallel-group controlled trial evaluates a multimodal AI-driven, human-AI collaborative out-of-hospital health management system for adults with hypertension and cardiometabolic risk factors. A central randomization system will allocate 150 participants in a 1:1 ratio to hybrid AI-assisted management or standard out-of-hospital guidance. Follow-up lasts 6 months.
The intervention integrates clinical data, patient-generated data, and device data from Huawei wearable bands/watches, blood pressure monitors, and glucose meters. An AI agent informed by the COM-B and Fogg behavior models generates personalized recommendations, monitoring tasks, reminders, adherence support, and risk alerts. Healthcare professionals review, modify, and approve key recommendations, respond to medical questions, and manage alerts. The control group receives a printed health education booklet, instructions on medication use and follow-up, and usual clinical care without the study digital system or additional proactive follow-up.
Study visits occur at screening, baseline, Month 3, and Month 6, with additional telephone follow-up. Blood pressure is measured using a HUAWEI WATCH D2. Laboratory assessments include glucose, lipids, insulin, HbA1c, and free fatty acids after an 8-hour fast. The primary endpoint is a participant-level composite of blood pressure target attainment and target attainment for at least one glycemic or lipid indicator at Month 6. Secondary and exploratory assessments cover multidimensional adherence, major adverse cardiovascular events, all-cause hospitalization, medical costs related to hypertension, hyperlipidemia, hyperglycemia, and hyperuricemia, SF-36 quality of life, and System Usability Scale ratings.
The planned analysis uses intention-to-treat principles, with chi-square tests and logistic regression for the primary endpoint, analysis of covariance for continuous changes, Kaplan-Meier methods for cardiovascular events, and multiple imputation for missing primary and secondary outcome data.
6,845 studies on the registry are indexed under Hypertension; 976 are open to participants now.
This study's planned enrollment of 150 is above the median of 90 across 5,105 interventional studies indexed under Hypertension.
Browse Hypertension studies →China National Center for Cardiovascular Diseases is the lead sponsor of 266 studies on the registry; 138 are open to participants now.
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Exclusion Criteria:
Participants use a patient mini-program with automatically synchronized wearable-device, blood pressure, and glucose data plus manual lifestyle entries. An AI agent generates personalized medication reminders, dietary advice, exercise plans, monitoring tasks, education, and risk alerts. Healthcare professionals review, modify, and approve recommendations and manage medical questions and alerts for 6 months.
Behavioral: Hybrid AI-Enabled Out-of-Hospital Health Management
Participants receive routine discharge health education and a printed booklet, with instructions to take medications as prescribed and attend regular follow-up visits. They do not receive the study digital system or additional proactive follow-up beyond usual clinical care. Follow-up lasts 6 months.
Behavioral: Standard Out-of-Hospital Guidance
A 6-month personalized digital health intervention integrating multimodal clinical, patient-generated, and device data. AI informed by COM-B and Fogg behavior models provides lifestyle and medication-adherence support, monitoring tasks, reminders, and risk alerts; healthcare professionals review and confirm key recommendations and provide clinical oversight.
Routine health education at discharge, including a printed booklet and advice on medication adherence and regular follow-up, with usual clinical follow-up for 6 months and no study digital system or additional proactive follow-up.
Proportion of Participants Achieving Blood Pressure Control and Control of at Least One Glycemic or Lipid Indicator
Proportion of participants achieving both: (1) blood pressure \<140/90 mmHg for general hypertension, or \<130/80 mmHg for participants with metabolic syndrome; and (2) at least one glycemic or lipid target. Glycemic target: fasting plasma glucose \<7.0 mmol/L and HbA1c \<7.0%. LDL-C target: \<2.6 mmol/L for intermediate ASCVD risk or \<1.8 mmol/L for high/very high ASCVD risk.
Time frame: At 6 months after randomization
Composite Treatment and Health-Management Adherence
Composite adherence assessed using MMAS-8 (score ≥6 indicates good medication adherence) and system data. Good monitoring adherence: ≥4 valid blood pressure measurements/week. Good home-monitoring adherence: ≥80% of AI-recommended tasks completed/week. Dietary/physical-activity adherence is defined in the protocol using achievement of at least 4 of 5 domains (medication, monitoring, diet, physical activity, follow-up), with \>80% of participants meeting this threshold.
Time frame: At 6 months after randomization
Incidence of Major Adverse Cardiovascular Events (MACE)
Composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke.
Time frame: From randomization through 6 months
Health-Related Quality of Life (SF-36 Score)
Assessed using the 36-Item Short Form Health Survey (SF-36).
Time frame: Baseline and 6 months after randomization
System Satisfaction and Usability (System Usability Scale Score)
Patient and healthcare-professional satisfaction and usability assessed using the System Usability Scale (SUS).
Time frame: At 6 months after randomization
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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