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

T

Taipei Medical University

Status

Completed

Conditions

Hypertension

Treatments

Device: Cloud-based home BP monitoring

Study type

Interventional

Funder types

Other

Identifiers

NCT02175511
NSC 100-2622-E-038-001-CC2

Details and patient eligibility

About

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.

Full 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.

Enrollment

382 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

382 participants in 2 patient groups

Cloud-based home BP monitoring
Experimental group
Description:
170 were assigned to the experimental group
Treatment:
Device: Cloud-based home BP monitoring
Traditional Care
No Intervention group
Description:
212 patients were assigned to the traditional care group (paper-based data)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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