Multimodal AI-Driven Out-of-Hospital Management for Hypertension and Cardiometabolic Risk (no acronym)

October 30, 2026 updated by: China National Center for Cardiovascular Diseases

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Behavioral: Hybrid AI-Enabled Out-of-Hospital Health Management

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.
Active Comparator: 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.
Behavioral: Standard Out-of-Hospital Guidance

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of Participants Achieving Blood Pressure Control and Control of at Least One Glycemic or Lipid Indicator
Time Frame: 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
Time Frame: 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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of Major Adverse Cardiovascular Events (MACE)
Time Frame: 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)
Time Frame: 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)
Time Frame: At 6 months after randomization

Patient and healthcare-professional satisfaction and usability assessed using the System Usability Scale (SUS).
At 6 months after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
China National Center for Cardiovascular Diseases

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 3, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 30, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2026-3046

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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