Study of a Comprehensive Intelligent Hypertension managEment SyStem (CHESS) Evaluation in Primary Health Care Settings
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hypertension
- Sponsor
- China National Center for Cardiovascular Diseases
- Enrollment
- 1600
- Locations
- 1
- Primary Endpoint
- Mean change in 24-hour ambulatory SBP from baseline to 12-month follow up;
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Proportion of patients with office BP under control at 12-month;(Baseline; 12 months)
- Proportion of hypertension visits during which inappropriate antihypertensive treatment is prescribed;(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)
- Change in patients' medication adherence of antihypertensive drugs;(Baseline; 12 months)
- Mean changes in 24-hour ambulatory DBP from baseline to 12-month;(Baseline; 12 months)
- Proportion of patients with 24-hour ambulatory BP under control (<130/80 mmHg) at 12-month;(Baseline; 12 months)
- Mean changes in 24-hour ABPM heart rate from baseline to 12-month;(Baseline; 12 months)