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

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Device: Cloud-based home BP monitoring

• Registration Number: NCT02175511
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2012-06
• Study Start: 2012-12
• Primary Completion: 2013-12
• Study Completion: 2014-03
• Study First Submitted: 2014-06-09
• Study First Submitted QC: 2014-06-24
• Last Update Submitted: 2014-06-24
• Study First Posted: 2014-06-26
• Last Update Posted: 2014-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 382

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cloud-based home BP monitoring	Cloud-based home BP monitoring	170 were assigned to the experimental group

Primary Outcome Measures

Name	Time	Method
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

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