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

Cloud BP System Integrated With CPOE Improves Self-Management of the Hypertensive Patients: A Randomized Controlled Trial Study

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Device: Cloud-based home BP monitoring

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.

• Study Type: Interventional
• Enrollment (Actual): 382
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The proportion of patients with controlled BP (<140/90 mm Hg)	Patients who participated in this trial will be followed for an expected average of 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
The changes in BP and antihypertensive drug prescription	Patients who participated in this trial will be followed for an expected average of 6 months

Collaborators and Investigators

• Sponsor: Taipei Medical University
• Collaborators: National Science Council, Taiwan
• Investigators: Study Chair: Yu-Chuan Li, MD., PhD., Taipei Medical University; Study Director: Peisan Lee, MA, Taipei Medical University

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: June 9, 2014
• First Submitted That Met QC Criteria: June 24, 2014
• First Posted (Estimate): June 26, 2014

Study Record Updates

• Last Update Posted (Estimate): June 26, 2014
• Last Update Submitted That Met QC Criteria: June 24, 2014
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Hypertension; Telemonitoring; Home Blood Pressure; Computerized physician order entry (CPOE)
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: NSC 100-2622-E-038-001-CC2