Study of a Comprehensive Intelligent Hypertension managEment SyStem

Not Applicable

Not yet recruiting

• Conditions: Hypertension
• Interventions: Behavioral: CHESS intervention

• Registration Number: NCT05605418
• Lead Sponsor: China National Center for Cardiovascular Diseases

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.

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 Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-27
• Study First Submitted QC: 2022-10-29
• Last Update Submitted: 2022-10-29
• Study First Posted: 2022-11-04
• Last Update Posted: 2022-11-04
• Study Start: 2023-01-01
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1600

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with office BP under control at 12-month;	Baseline; 12 months	Office BP under control is defined as blood pressure \<130/80 mmHg at hypertension clinic.
Proportion of hypertension visits during which inappropriate antihypertensive treatment is prescribed;	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.
Mean changes in office SBP from baseline to 12-month;	Baseline; 12 months	Patient's office SBP will be measured at hypertension clinics.
Mean changes in office DBP from baseline to 12-month;	Baseline; 12 months	Patient's office DBP will be measured at hypertension clinics.
Change in patients' medication adherence of antihypertensive drugs;	Baseline; 12 months	The investigators will measure patients medication adherence using information collected in questionnaire at baseline and 12 month follow up visits.
Mean changes in 24-hour ambulatory DBP from baseline to 12-month;	Baseline; 12 months	The investigators will measure the change in 24-h ambulatory DBP from baseline to 12 months.
Proportion of patients with 24-hour ambulatory BP under control (<130/80 mmHg) at 12-month;	Baseline; 12 months	Ambulatory BP under control is defined as mean ambulatory BP \<130/80 mmHg.
Mean changes in 24-hour ABPM heart rate from baseline to 12-month;	Baseline; 12 months	The investigators will measure the change in 24-h ambulatory heart rate from baseline to 12 months.

Trial Locations

Locations (1)

Fuwai Hospital, Chinese Academy of Medical Sciences, National Center for Cardiovascular Diseases; 🇨🇳 Beijing, China