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A Randomized Controlled Trial for Hypertension Control by Integrating Cloud BP System and CPOE

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02175511
Recruitment Status : Completed
First Posted : June 26, 2014
Last Update Posted : June 26, 2014
National Science Council, Taiwan
Information provided by (Responsible Party):
Taipei Medical University

Brief Summary:

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

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 382 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Secondary hypertension
  • Expectant mother
  • Stroke, myocardial infarction or had surgery within 3 months
  • Atrial fibrillation
  • Inter-arm difference (IAD) >20 mm Hg
  • Unsuitability as recognized by physicians.

Exclusion Criteria:

  • Unable to participate in this trial for the whole process
  • Lived alone and unable to read Text Message

Information from the National Library of Medicine

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 identifier (NCT number): NCT02175511

Sponsors and Collaborators
Taipei Medical University
National Science Council, Taiwan
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Study Chair: Yu-Chuan Li, MD., PhD. Taipei Medical University
Study Director: Peisan Lee, MA Taipei Medical University
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Responsible Party: Taipei Medical University Identifier: NCT02175511    
Other Study ID Numbers: NSC 100-2622-E-038-001-CC2
First Posted: June 26, 2014    Key Record Dates
Last Update Posted: June 26, 2014
Last Verified: June 2012
Keywords provided by Taipei Medical University:
Home Blood Pressure
Computerized physician order entry (CPOE)
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases