Study of a Comprehensive Intelligent Hypertension managEment SyStem

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hypertension

Intervention / Treatment
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* Behavioral: CHESS intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for Sites: 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. Inclusion Criteria for Participants: 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. Exclusion Criteria for participants: 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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CHESS intervention<br>Physicians and patients at the intervention group will receive training and support on the use of the multi-faceted CHESS system. | Behavioral: CHESS intervention<br>* 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.<br>|
| No Intervention: Control<br>After site randomization, physicians at the control sites will manage their patients by usual care at hypertension clinics. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean changes in 24-hour ambulatory DBP from baseline to 12-month; | 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; | Patient's office SBP will be measured at hypertension clinics. | Baseline; 12 months | 
| Mean changes in office DBP from baseline to 12-month; | Patient's office DBP will be measured at hypertension clinics. | Baseline; 12 months | 
| Proportion of patients with office BP under control at 12-month; | 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; | 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; | 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; | 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; | The investigators will measure patients medication adherence using information collected in questionnaire at baseline and 12 month follow up visits. | Baseline; 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Digital intervention, Ambulatory blood pressure, Home blood pressure monitoring, Cluster randomized controlled trial