Clinical trial NCT04371874: The Standardized Management of Hypertension in Rural Shaanxi
Official title: The Standardized and Economical Mode for the Prevention and Management of Chronic Cardiovascular Diseases: Matrix System From Rural Shaanxi ( MATRIX ) Ⅰ
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: hypertension management; rural areas; control rate
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2020-05-01
Enrollment: 1210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: the improvement of control rate of hypertension with low-cost in rural Shaanxi
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: the first affiliated hospital of Xi'an Jiaotong university
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Hongyan Tian
role: STUDY_CHAIR
References: