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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hypertension

Intervention / Treatment
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* Device: Cloud-based home BP monitoring


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cloud-based home BP monitoring<br>170 were assigned to the experimental group | Device: Cloud-based home BP monitoring<br>* 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.<br>|
| No Intervention: Traditional Care<br>212 patients were assigned to the traditional care group (paper-based data) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Home Blood Pressure, Computerized physician order entry (CPOE), Telemonitoring, Hypertension