A Randomized Controlled Trial for Hypertension Control by Integrating Cloud BP System and CPOE
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|ClinicalTrials.gov Identifier: NCT02175511|
Recruitment Status : Completed
First Posted : June 26, 2014
Last Update Posted : June 26, 2014
Importance: Less than fifty percent of patients with hypertensive disease manage to maintain their blood pressure (BP) within normal levels. Practical (Pragmatic) and sustainable models are needed in order to improve BP management in patients with hypertension.
Objective: To evaluate whether cloud BP system integrated with computerized physician order entry (CPOE) is useful for improving BP management as compared with traditional care.
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Device: Cloud-based home BP monitoring||Not Applicable|
Design, Setting and Patients: A randomized clinical trial study of 382 adults recruited from 786 patients who had been diagnosed with hypertension and receiving treatment for hypertension in two district hospitals in the north of Taiwan. Physicians had access to cloud-based BP data from CPOE. Neither participants nor investigators were blinded to group assignment. The study was conducted for a period of seven months.
Interventions: Patients from two hospitals were randomized into a control group which received traditional care (n=212) and an intervention group (n=170) which received a cloud-based home BP monitoring device. The device measured and transmitted BP data to the cloud server, which was integrated with the CPOE system in the hospitals. Physicians could access the BP data during the patient encounter to adjust the antihypertensive therapy accordingly. Meanwhile, patients could browse their own BP data from their computers, smart phones, tablets and so on.
Primary Outcome(s) and Measure(s): The primary outcomes were control of systolic BP to less than 140 mm Hg and diastolic BP to less than 90 mm Hg at two, four and six months. The secondary outcomes were changes in BP and antihypertensive drug prescription at two, four and six months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||382 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Cloud BP System Integrated With CPOE Improves Self-Management of the Hypertensive Patients: A Randomized Controlled Trial Study|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||March 2014|
Experimental: Cloud-based home BP monitoring
170 were assigned to the experimental group
Device: Cloud-based home BP monitoring
a sphygmomanometer-style BP measurement device (Microlife®, "WatchBP Home") that stored and transmitted data to a secure cloud BP system directly via a General Packet Radio Service (GPRS) gateway through cell phone network.
No Intervention: Traditional Care
212 patients were assigned to the traditional care group (paper-based data)
- The proportion of patients with controlled BP (<140/90 mm Hg) [ Time Frame: Patients who participated in this trial will be followed for an expected average of 6 months ]
- The changes in BP and antihypertensive drug prescription [ Time Frame: Patients who participated in this trial will be followed for an expected average of 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02175511
|Study Chair:||Yu-Chuan Li, MD., PhD.||Taipei Medical University|
|Study Director:||Peisan Lee, MA||Taipei Medical University|