Study of a Comprehensive Intelligent Hypertension managEment SyStem (CHESS)

May 2, 2026 updated by: China National Center for Cardiovascular Diseases

Study of a Comprehensive Intelligent Hypertension managEment SyStem (CHESS) Evaluation in Primary Health Care Settings

This cluster randomized controlled trial aims to evaluate the efficacy of a comprehensive intelligent hypertension management system (CHESS) in blood pressure lowering in primary health care (PHC) settings of China.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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

The trial aims to investigate the efficacy of a comprehensive digital intervention for hypertension treatment in cluster clinics. 40 PHC centers will be selected from different areas in China, and eligible patients being screened consecutively in each site, then all PHC centers will be randomized into intervention group and control group. The physicians and patients from the 20 intervention sites will receive training and support on the use of the CHESS system, and the control group will continue to receive usual care. The multi-faceted CHESS intervention includes: (1) home blood pressure monitoring (HBPM) for patients, and the data will be uploaded to central electronic health records (EHR) automatically; (2) a Smart Reminder and Alert System (SRAS) to send educational messages and reminders to support patients on HBPM, improve blood pressure medication adherence and lifestyle modification; (3) a decision support system (DSS) to provide physicians with antihypertensive medications prescriptions and referral recommendations; (4) regular quality assessment reports will be provided to health care providers automatically to improve the quality of hypertension management at PHC level. All participants will be asked to attend the clinic at least once every 3 months, and be followed up for 12 months.

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 (Actual)

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.
1666

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.

Study Contact Backup

Study Locations

  • China
      • Beijing, China
        • Fuwai Hospital, Chinese Academy of Medical Sciences, National Center for Cardiovascular Diseases

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

35 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria for Sites:

  1. An electronic data collection system is routinely used at the clinic for hypertension management in PHC sites, and the distance between sites must be >2km;

  2. At least one drug of each of the five classes of recommended antihypertensive medications is available at the clinic:

    • A: Angiotensin-converting enzyme inhibitors (ACEI; e.g., captopril or enalapril);
    • A: Angiotensin receptor blockers (ARB; e.g., losartan or valsartan)
    • B: β-blockers (e.g., atenolol, metoprolol, or bisoprolol)
    • C: Calcium antagonists (e.g., nitrendipine, nifedipine, or amlodipine)
    • D: Diuretics (e.g., hydrochlorothiazide, indapamide, or indapamide SR tablets)
  3. Has an outpatient clinic for hypertension treatment and staff are willing to take part in the study.

Inclusion Criteria for Participants:

  1. Age ≥35 years and <80 years
  2. Local resident of the community/township who attends the PHC clinic for hypertension management, and will not travel for more than 3 months during the study period;
  3. Established diagnosis of essential hypertension, with uncontrolled BP before randomization (defined as office BP≥140/90mmHg, and 24-hour ambulatory BP≥130/80mmHg);
  4. Own and be able to use a smartphone daily;
  5. Be willing to participate in the study and sign the informed consent.

Exclusion Criteria for participants:

  1. Physician-diagnosed or suspected secondary hypertension (e.g. hypertension caused by renal disease, renal artery stenosis, aortic stenosis, primary aldosteronism, pheochromocytoma/paraganglioma, Cushing's syndrome, thyroid dysfunction, intracranial disease, drug- induced, or rare monogenic genetic disease), or the presence of other structural heart diseases, such as aortic insufficiency, hypertrophic cardiomyopathy, or congenital heart disease;
  2. Office or ambulatory SBP≥180 mmHg and/or DBP≥110 mmHg before randomization;
  3. Physician-diagnosed atrial fibrillation;
  4. Physician-diagnosed CKD, estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 (if serum creatinine is available), or currently on dialysis treatment;
  5. Physician-diagnosed hepatic dysfunction, or ALT≥ 2*ULN;
  6. Currently at the unstable or terminal stage of any disease (e.g. new- onset cardiovascular and cerebrovascular diseases occurred within 3 months, malignant tumors);
  7. Intolerance to at least two classes of antihypertensive medications among A, B, C or D;
  8. Currently taking 3 or more antihypertensive drugs;
  9. The subject is pregnant or breastfeeding, or planning to become pregnant or breastfeeding during the study period;
  10. Have communication or cognitive disorders;
  11. Be unwilling to take antihypertensive drugs, or assumed poor adherence to treatment;
  12. The subject is participating in other clinical trials at the moment.

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: Single

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: CHESS intervention
Physicians and patients at the intervention group will receive training and support on the use of the multi-faceted CHESS system.
Behavioral: CHESS intervention
The multi-faceted CHESS intervention includes: (1) home blood pressure monitoring (HBPM) for patients, and the data will be uploaded to central electronic health records (EHR) automatically; (2) a Smart Reminder and Alert System (SRAS) to send educational messages and reminders to support patients on HBPM, improve blood pressure medication adherence and lifestyle modification; (3) a decision support system (DSS) to provide physicians with antihypertensive medications prescriptions and referral recommendations; (4) regular quality assessment reports will be provided to health care providers automatically to improve the quality of hypertension management at PHC level.
No Intervention: Control
After site randomization, physicians at the control sites will manage their patients by usual care at hypertension clinics.

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
Mean change in 24-hour ambulatory SBP from baseline to 12-month follow up;
Time Frame: Baseline; 12 months
The investigators will measure the change in 24-h ambulatory SBP from baseline to 12 months.
Baseline; 12 months

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
Mean changes in 24-hour ambulatory DBP from baseline to 12-month;
Time Frame: Baseline; 12 months
The investigators will measure the change in 24-h ambulatory DBP from baseline to 12 months.
Baseline; 12 months
Mean changes in office SBP from baseline to 12-month;
Time Frame: Baseline; 12 months
Patient's office SBP will be measured at hypertension clinics.
Baseline; 12 months
Mean changes in office DBP from baseline to 12-month;
Time Frame: Baseline; 12 months
Patient's office DBP will be measured at hypertension clinics.
Baseline; 12 months
Proportion of patients with office BP under control at 12-month;
Time Frame: Baseline; 12 months
Office BP under control is defined as blood pressure <130/80 mmHg at hypertension clinic.
Baseline; 12 months
Proportion of patients with 24-hour ambulatory BP under control (<130/80 mmHg) at 12-month;
Time Frame: Baseline; 12 months
Ambulatory BP under control is defined as mean ambulatory BP <130/80 mmHg.
Baseline; 12 months
Mean changes in 24-hour ABPM heart rate from baseline to 12-month;
Time Frame: Baseline; 12 months
The investigators will measure the change in 24-h ambulatory heart rate from baseline to 12 months.
Baseline; 12 months
Proportion of hypertension visits during which inappropriate antihypertensive treatment is prescribed;
Time Frame: Baseline; 12 months
Inappropriate antihypertensive treatment is defined as a prescription incompliant with the pre-specified guideline-based recommendations. Antihypertensive treatment prescriptions will be measured and obtained through questionnaire and medical records information and be compared with decision support system recommendations automatically.
Baseline; 12 months
Change in patients' medication adherence of antihypertensive drugs;
Time Frame: Baseline; 12 months
The investigators will measure patients medication adherence using information collected in questionnaire at baseline and 12 month follow up visits.
Baseline; 12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean changes in ambulatory daytime SBP from baseline to 12-month;
Time Frame: Baseline; 12 months
Ambulatory daytime SBP will be measured according to 24-hour ABPM.
Baseline; 12 months
Mean changes in ambulatory daytime DBP from baseline to 12-month;
Time Frame: Baseline; 12 months
Ambulatory daytime DBP will be measured according to 24-hour ABPM.
Baseline; 12 months
Mean changes in ambulatory nighttime SBP from baseline to 12-month;
Time Frame: Baseline; 12 months
Ambulatory nighttime SBP will be measured according to 24-hour ABPM.
Baseline; 12 months
Mean changes in ambulatory nighttime DBP from baseline to 12-month;
Time Frame: Baseline; 12 months
Ambulatory nighttime DBP will be measured according to 24-hour ABPM.
Baseline; 12 months
Mean changes in BMI from baseline to 12-month;
Time Frame: Baseline; 12 months
BMI will be measured by dividing weight in kilograms by height in metres squared.
Baseline; 12 months
Changes in physical activity level from baseline to 12-month;
Time Frame: Baseline; 12 months
We will measure the change in self-reported physical activity scale through questionnaire from baseline to 12 months.
Baseline; 12 months
Changes in smoking proportions from baseline to 12-month;
Time Frame: Baseline; 12 months
We will measure the change in self-reported smoking status through questionnaire from baseline to 12 months.
Baseline; 12 months
Proportions of patients with major cardiovascular events during follow-up period.
Time Frame: Baseline; 12 months
Major cardiovascular events are defined as cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and hospitalization for heart failure.
Baseline; 12 months

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

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shengshou Hu, PhD, National Center for Cardiovascular Diseases

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

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.
March 16, 2023

Primary Completion (Actual)

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.
October 30, 2024

Study Completion (Actual)

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.
October 30, 2024

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 27, 2022

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 29, 2022

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, 2022

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.
May 5, 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.
May 2, 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.
May 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.
  • 2022-GSP-GG-21

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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