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Completed

NCT Number: NCT02175511

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cloud-based home BP monitoring

Device

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Collaborators

  • National Science and Technology Council, Taiwan

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Jun 26, 2014
Registry last updated
Jun 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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