Multimodal AI-Driven Out-of-Hospital Management for Hypertension and Cardiometabolic Risk (no acronym)
Effects of Multimodal Artificial Intelligence-Driven Out-of-Hospital Management on Patients With Hypertension and Cardiometabolic Risk Factors
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.
Przegląd badań
Status
Warunki
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Yifan Wu, master
- Numer telefonu: 01088398069
- E-mail: wuyifan1127@126.com
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Aged 18-70 years.
- Confirmed hypertension plus at least one of dyslipidemia, hyperglycemia, or abdominal obesity, with at least one condition not at target. Hypertension: BP ≥130/85 mmHg and/or diagnosed hypertension under treatment. Hyperglycemia: fasting glucose ≥6.1 mmol/L or 2-hour post-load glucose ≥7.8 mmol/L and/or diagnosed diabetes under treatment. Abdominal obesity: waist circumference ≥90 cm in men or ≥85 cm in women. Dyslipidemia: fasting triglycerides ≥1.7 mmol/L, LDL-C ≥4.1 mmol/L in the general population, or failure to meet the ASCVD risk-stratified LDL-C target (<2.6 mmol/L for general low-risk adults; <1.8 mmol/L for specified higher-risk groups; <1.4 mmol/L for specified very-high-risk ASCVD groups).
- Able to use a smartphone and smart wearable devices.
- Relatively stable work/life circumstances and residence for the next 6 months.
- Voluntary participation and signed informed consent.
Exclusion Criteria:
- Secondary hypertension, acute hypertension, subacute hypertension, or hypertensive encephalopathy.
- Severe primary hypertension (SBP ≥180 mmHg and/or DBP ≥110 mmHg) or poorly controlled primary hypertension.
- Acute myocardial infarction, unstable angina, or coronary revascularization (PCI or CABG) within 6 months.
- Cerebral infarction or cerebral hemorrhage within 6 months.
- Severe heart failure (NYHA class III-IV).
- Uncontrolled severe arrhythmia, such as symptomatic ventricular tachycardia or high-grade atrioventricular block.
- Chronic kidney disease.
- Severe psychiatric illness preventing cooperation.
- Life expectancy <12 months.
- ALT or AST ≥3 × ULN; for patients receiving lipid-lowering therapy, ALT or AST ≥2 × ULN that does not normalize after drug discontinuation.
- Other severe conditions preventing digital management, including severe visual/hearing impairment or cognitive dysfunction.
- Any other condition considered by the investigator to make participation unsuitable.
- Participation in another clinical study within 3 months.
- Refusal to sign informed consent.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Hybrid AI-Assisted Out-of-Hospital Management
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. |
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. |
|
Aktywny komparator: Control
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. |
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. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Proportion of Participants Achieving Blood Pressure Control and Control of at Least One Glycemic or Lipid Indicator
Ramy czasowe: At 6 months after randomization
|
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. |
At 6 months after randomization
|
|
Composite Treatment and Health-Management Adherence
Ramy czasowe: At 6 months after randomization
|
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. |
At 6 months after randomization
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Incidence of Major Adverse Cardiovascular Events (MACE)
Ramy czasowe: From randomization through 6 months
|
Composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke. |
From randomization through 6 months
|
|
Health-Related Quality of Life (SF-36 Score)
Ramy czasowe: Baseline and 6 months after randomization
|
Assessed using the 36-Item Short Form Health Survey (SF-36). |
Baseline and 6 months after randomization
|
|
System Satisfaction and Usability (System Usability Scale Score)
Ramy czasowe: At 6 months after randomization
|
Patient and healthcare-professional satisfaction and usability assessed using the System Usability Scale (SUS). |
At 6 months after randomization
|
Współpracownicy i badacze
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2026-3046
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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