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Study of a Comprehensive Intelligent Hypertension managEment SyStem (CHESS)

Primary Purpose

Hypertension

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
CHESS intervention
Sponsored by
China National Center for Cardiovascular Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Hypertension, Digital intervention, Ambulatory blood pressure, Home blood pressure monitoring, Cluster randomized controlled trial

Eligibility Criteria

35 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CHESS intervention

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Mean changes in office SBP from baseline to 12-month;
Patient's office SBP will be measured at hypertension clinics.
Mean changes in office DBP from baseline to 12-month;
Patient's office DBP will be measured at hypertension clinics.
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.
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.
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.
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.
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.

Full Information

First Posted
October 27, 2022
Last Updated
October 29, 2022
Sponsor
China National Center for Cardiovascular Diseases
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1. Study Identification

Unique Protocol Identification Number
NCT05605418
Brief Title
Study of a Comprehensive Intelligent Hypertension managEment SyStem
Acronym
CHESS
Official Title
Study of a Comprehensive Intelligent Hypertension managEment SyStem (CHESS) Evaluation in Primary Health Care Settings
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2023 (Anticipated)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China National Center for Cardiovascular Diseases

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Hypertension, Digital intervention, Ambulatory blood pressure, Home blood pressure monitoring, Cluster randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CHESS intervention
Arm Type
Experimental
Arm Description
Physicians and patients at the intervention group will receive training and support on the use of the multi-faceted CHESS system.
Arm Title
Control
Arm Type
No Intervention
Arm Description
After site randomization, physicians at the control sites will manage their patients by usual care at hypertension clinics.
Intervention Type
Behavioral
Intervention Name(s)
CHESS intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean change in 24-hour ambulatory SBP from baseline to 12-month follow up;
Description
The investigators will measure the change in 24-h ambulatory SBP from baseline to 12 months.
Time Frame
Baseline; 12 months
Secondary Outcome Measure Information:
Title
Mean changes in 24-hour ambulatory DBP from baseline to 12-month;
Description
The investigators will measure the change in 24-h ambulatory DBP from baseline to 12 months.
Time Frame
Baseline; 12 months
Title
Mean changes in office SBP from baseline to 12-month;
Description
Patient's office SBP will be measured at hypertension clinics.
Time Frame
Baseline; 12 months
Title
Mean changes in office DBP from baseline to 12-month;
Description
Patient's office DBP will be measured at hypertension clinics.
Time Frame
Baseline; 12 months
Title
Proportion of patients with office BP under control at 12-month;
Description
Office BP under control is defined as blood pressure <130/80 mmHg at hypertension clinic.
Time Frame
Baseline; 12 months
Title
Proportion of patients with 24-hour ambulatory BP under control (<130/80 mmHg) at 12-month;
Description
Ambulatory BP under control is defined as mean ambulatory BP <130/80 mmHg.
Time Frame
Baseline; 12 months
Title
Mean changes in 24-hour ABPM heart rate from baseline to 12-month;
Description
The investigators will measure the change in 24-h ambulatory heart rate from baseline to 12 months.
Time Frame
Baseline; 12 months
Title
Proportion of hypertension visits during which inappropriate antihypertensive treatment is prescribed;
Description
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.
Time Frame
Baseline; 12 months
Title
Change in patients' medication adherence of antihypertensive drugs;
Description
The investigators will measure patients medication adherence using information collected in questionnaire at baseline and 12 month follow up visits.
Time Frame
Baseline; 12 months
Other Pre-specified Outcome Measures:
Title
Mean changes in ambulatory daytime SBP from baseline to 12-month;
Description
Ambulatory daytime SBP will be measured according to 24-hour ABPM.
Time Frame
Baseline; 12 months
Title
Mean changes in ambulatory daytime DBP from baseline to 12-month;
Description
Ambulatory daytime DBP will be measured according to 24-hour ABPM.
Time Frame
Baseline; 12 months
Title
Mean changes in ambulatory nighttime SBP from baseline to 12-month;
Description
Ambulatory nighttime SBP will be measured according to 24-hour ABPM.
Time Frame
Baseline; 12 months
Title
Mean changes in ambulatory nighttime DBP from baseline to 12-month;
Description
Ambulatory nighttime DBP will be measured according to 24-hour ABPM.
Time Frame
Baseline; 12 months
Title
Mean changes in BMI from baseline to 12-month;
Description
BMI will be measured by dividing weight in kilograms by height in metres squared.
Time Frame
Baseline; 12 months
Title
Changes in physical activity level from baseline to 12-month;
Description
We will measure the change in self-reported physical activity scale through questionnaire from baseline to 12 months.
Time Frame
Baseline; 12 months
Title
Changes in smoking proportions from baseline to 12-month;
Description
We will measure the change in self-reported smoking status through questionnaire from baseline to 12 months.
Time Frame
Baseline; 12 months
Title
Proportions of patients with major cardiovascular events during follow-up period.
Description
Major cardiovascular events are defined as cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and hospitalization for heart failure.
Time Frame
Baseline; 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haibo Zhang, MD
Phone
+86 60866781
Email
haibo.zhang@fwoxford.org
First Name & Middle Initial & Last Name or Official Title & Degree
Xiqian Huo, PhD
Phone
+86 60866884
Email
xiqian.huo@fwoxford.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shengshou Hu, PhD
Organizational Affiliation
National Center for Cardiovascular Diseases
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fuwai Hospital, Chinese Academy of Medical Sciences, National Center for Cardiovascular Diseases
City
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haibo Zhang, MD
Phone
+86 60866781
Email
haibo.zhang@fwoxford.org

12. IPD Sharing Statement

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Study of a Comprehensive Intelligent Hypertension managEment SyStem

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