The Standardized Management of Hypertension in Rural Shaanxi

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04371874
• Other study ID #: GS610101-?
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: February 2019

Study information

• Verified date: April 2020
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1210
• Est. completion date: February 2019
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

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.

Locations

Country	Name	City	State
China	the first affiliated hospital of Xi'an Jiaotong university	Xi'an

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.