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CLINICAL REGISTRY STUDY
Year : 2018  |  Volume : 3  |  Issue : 4  |  Page : 117-121

Comparing an internet-based medical model with a conventional medical model in the management of patients with hypertension in China: Methodology of a cluster randomized study


1 Department of Cardiology, Peking University First Hospital, Beijing, China
2 Department of Cardiology, Peking University People's Hospital, Beijing, China
3 Chinese Hypertension League, Beijing, China
4 Department of Cardiology, Affiliated Hospital of Zunyi Medical College, Beijing, China
5 Medical Statistic Room, Peking University First Hospital, Beijing, China
6 Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China
7 Department of Chronic Disease, Kaili Municipal Health and Family Planning Bureau, Beijing, China
8 Department of Medical, Pfizer Investment Co., Ltd, Beijing, China

Correspondence Address:
Yong Huo
Peking University First Hospital, Beijing
China
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/cp.cp_31_18

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Background: The awareness, treatment, and control of hypertension are low in China. New and effective management model other than conventional hospital-based practices is needed to optimize the assessment and treatment of hypertension. Objectives: The objective of the study is to design a study that compares blood pressure (BP) control rate in hypertensive patients managed through an internet-based medical model versus conventional medical model. Methods: The study designed is a cluster randomized, unblinded controlled study which will be performed in 14 primary care clinics in Guizhou Province in southwest China. Sites will be randomized to provide BP management services to the patient through an internet-based medical model including home BP monitoring (HBPM) and telemonitoring by primary care physicians, or through a conventional medical model including HBPM and periodical visits to the clinic. Patients aged 45–75 years with two measurements of resting systolic BP (SBP) ≥140 mmHg and/or diastolic BP (DBP) ≥90 mmHg on different days during screening will be enrolled. The primary endpoint is the BP control rate, defined by the percentage of patients achieving target office BP (SBP <140 mmHg and DBP <90 mmHg). Using a superiority design, at least 958 patients were calculated to be sufficient to detect a 10% difference in BP control rate between groups, with a power of 85% and 15% drop out rate. Other outcomes include BP value, BP variability, treatment compliance, medical expense, and treatment satisfaction. Discussion and Conclusion: The results of the trial will be applicable to primary care services in China, especially in the west of China, where medical resources are less readily available. If successful, the internet-based management model with HBPM and telemonitoring from primary care physician may help to improve the BP control in patients in China. Clinical.gov Registration: NCT03527563.


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