Study of a Comprehensive Intelligent Hypertension managEment SyStem

NCT05605418 | Completed

• 1 other identifier: 2022-GSP-GG-21
• Study Type: interventional
• Target: 1,666
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension

Keywords

Hypertension; Digital intervention; Ambulatory blood pressure; Home blood pressure monitoring; Cluster randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Mean change in 24-hour ambulatory SBP from baseline to 12-month follow up;

  The investigators will measure the change in 24-h ambulatory SBP from baseline to 12 months.

  Baseline; 12 months

Secondary Outcomes (8)

• Mean changes in 24-hour ambulatory DBP from baseline to 12-month;

  Baseline; 12 months

• Mean changes in office SBP from baseline to 12-month;

  Baseline; 12 months

• Mean changes in office DBP from baseline to 12-month;

  Baseline; 12 months

• Proportion of patients with office BP under control at 12-month;

  Baseline; 12 months

• Proportion of patients with 24-hour ambulatory BP under control (<130/80 mmHg) at 12-month;

  Baseline; 12 months

Other Outcomes (8)

• Mean changes in ambulatory daytime SBP from baseline to 12-month;

  Baseline; 12 months

• Mean changes in ambulatory daytime DBP from baseline to 12-month;

  Baseline; 12 months

• Mean changes in ambulatory nighttime SBP from baseline to 12-month;

  Baseline; 12 months

Study Arms (2)

CHESS intervention

EXPERIMENTAL

Physicians and patients at the intervention group will receive training and support on the use of the multi-faceted CHESS system.

Behavioral: CHESS intervention

Control

NO INTERVENTION

After site randomization, physicians at the control sites will manage their patients by usual care at hypertension clinics.

Interventions

CHESS intervention BEHAVIORAL

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.

CHESS intervention

Eligibility Criteria

• Age: 35 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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)
• Has an outpatient clinic for hypertension treatment and staff are willing to take part in the study.
• Age ≥35 years and \<80 years
• 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;
• Established diagnosis of essential hypertension, with uncontrolled BP before randomization (defined as office BP≥140/90mmHg, and 24-hour ambulatory BP≥130/80mmHg);
• Own and be able to use a smartphone daily;
• Be willing to participate in the study and sign the informed consent.

You may not qualify if:

• 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;
• Office or ambulatory SBP≥180 mmHg and/or DBP≥110 mmHg before randomization;
• Physician-diagnosed atrial fibrillation;
• Physician-diagnosed CKD, estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m2 (if serum creatinine is available), or currently on dialysis treatment;
• Physician-diagnosed hepatic dysfunction, or ALT≥ 2\*ULN;
• Currently at the unstable or terminal stage of any disease (e.g. new- onset cardiovascular and cerebrovascular diseases occurred within 3 months, malignant tumors);
• Intolerance to at least two classes of antihypertensive medications among A, B, C or D;
• Currently taking 3 or more antihypertensive drugs;
• The subject is pregnant or breastfeeding, or planning to become pregnant or breastfeeding during the study period;
• Have communication or cognitive disorders;
• Be unwilling to take antihypertensive drugs, or assumed poor adherence to treatment;
• The subject is participating in other clinical trials at the moment.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

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

Beijing, China

Location

Related Publications (1)

• Zhang H, Huo X, Ren L, Lu J, Li J, Zheng X, Liu J, Ma W, Yuan J, Diao X, Wu C, Zhang X, Wang J, Zhao W, Hu S. Design and rationale of the Comprehensive intelligent Hypertension managEment SyStem (CHESS) evaluation study: A cluster randomized controlled trial for hypertension management in primary care. Am Heart J. 2024 Jul;273:90-101. doi: 10.1016/j.ahj.2024.03.018. Epub 2024 Apr 2.

  PMID: 38575049 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Shengshou Hu, PhD

  National Center for Cardiovascular Diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 4, 2022
• Study Start: March 16, 2023
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2024
• Last Updated: May 5, 2026

Record last verified: 2026-05

Locations

CN (1)