The Standardized Management of Hypertension in Rural Shaanxi

The Standardized and Economical Mode for the Prevention and Management of Chronic Cardiovascular Diseases: Matrix System From Rural Shaanxi ( MATRIX ) Ⅰ

The purpose of the study is to build a prevention and management system of hypertension in rural Shaanxi, China, which tries to use the standardized and economical methods to improve the outcome of chronic cardiovascular diseases.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Hydrochlorothiazide, Captopril, Nitrendipine, Aspirin

Detailed Description

Hypertension is common in China, but there are low rates of awareness (36.0%), treatment (22.9%) and control (5.7%) in the hypertension population of an estimated 200 million adults, a figure generated from the nationwide China Patient-Centered Evaluative Assessment of Cardiac Events (PEACE) Million Person Project (MPP) . Substantial health and economic burdens are caused by hypertension, and adequate control of blood pressure (BP) has been a national public health priority. In China, nearly half of population are living in rural areas , where lower treatment and control rates of hypertension compared with urban areas. Expenditure of antihypertension medications and insufficient professional ability of rural doctors were the major problems facing hypertension management in rural areas of China with backward economies.

Absence of affordable medications prescribed may be a major barrier to adherence to medications. The rural doctors with insufficient professional ability had not to provide standard management of hypertension. So, an effective, cheap and simple hypertension control strategy was urgently needed in underdeveloped rural areas.

My center has been devoted to the study of hypertension in economically backward rural areas of Shaanxi Province in Western China for decades. We provided a cheap and simple hypertension management plan suitable for these areas. Because the cost of the management was about $10 dollars per year, the plan was called the ten dollars project (TDP). The TDP included a management system and a cheap treatment plan. The management software for hypertension was designed to help rural doctors with poor professional medical ability standardly manage hypertension adhering to the guidelines. Of course, a more effective and affordable treatment costing about ten dollars a year is the core of this system. The aim of this study was to measure whether the TDP can effectively improve the control of hypertension in rural areas.

• Study Type: Interventional
• Enrollment (Actual): 1210
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Xi'an, China
    • The First Affiliated Hospital of Xi'an Jiaotong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• primary hypertension;
• Age ≥ 18 years old;

Exclusion Criteria:

• Secondary hypertension;
• the acute onset of cardiovascular events within three months;
• severe liver disease (ALT increased 2-fold greater than creatinine 2.5mg/dl);
• Severe cardiomyopathy, congenital heart disease, rheumatic heart disease
• malignancies
• allergic to study drugs
• with clear contraindications on study drugs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control; Hypertension of patients in the control group was managed with the original protocol including lifestyle by doctors in village clinic.
EXPERIMENTAL: Treatment with Ten Dollars Project (TDP); Hypertension of patients in the TDP group were managed with the protocol of "Ten Dollars Project (TDP)" by doctors in village clinic.	Drug: Hydrochlorothiazide, Captopril, Nitrendipine, Aspirin; The participants were grouped into a control group and a TDP group. Hypertension of patients in the control group was managed with the original protocol by doctors in village clinics. Patients in the TDP group were supplied with the TDP treatment, for whom different levels of oral administration plans to patients without drugs treatment in original protocol were: G 0 and G I, nifedipine (20mg, bid) or captopril (25mg, tid), hydrochlorothiazide (12.5mg, bid) for patients who couldn't tolerate previous drugs; G II, nifedipine (20mg, bid) plus hydrochlorothiazide (12.5mg, bid), or captopril (25mg, tid) plus hydrochlorothiazide (12.5mg, bid ), triple therapy for patients whose blood pressure did not reach target BP; G III, three drugs combination. Patients with drugs treatments in the original protocol were changed to be treated with the above antihypertension medications which were uniformly supplied by the government.; Other Names: medications were uniformly supplied by the Chinese government

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the improvement of control rate of hypertension with low-cost in rural Shaanxi	value whether the protocol of TDP could improve the control rate of hypertension in rural Shaanxi	Patients in the TDP group accepted protocol of TDP to manage hypertension and patients in the control group were managed by the original protocol for six months. Compare the change of control rate at baseline and the end of the sixth month.

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Investigators: Study Chair: Hongyan Tian, First Affiliated Hospital Xi'an Jiaotong University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2014
• Primary Completion (ACTUAL): July 1, 2017
• Study Completion (ACTUAL): February 1, 2019

Study Registration Dates

• First Submitted: April 29, 2020
• First Submitted That Met QC Criteria: April 29, 2020
• First Posted (ACTUAL): May 1, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 1, 2020
• Last Update Submitted That Met QC Criteria: April 29, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: hypertension management; rural areas; control rate
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Protease Inhibitors; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Angiotensin-Converting Enzyme Inhibitors; Sodium Chloride Symporter Inhibitors; Aspirin; Hydrochlorothiazide; Captopril; Nitrendipine
• Other Study ID Numbers: GS610101-Ⅰ