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

NCT ID: NCT02175511

Last Updated: 2014-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 382 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2014-03-31

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Cloud-based home BP monitoring

170 were assigned to the experimental group

Group Type: EXPERIMENTAL

Cloud-based home BP monitoring

Intervention Type: 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.

Traditional Care

212 patients were assigned to the traditional care group (paper-based data)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role: collaborator

Taipei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yu-Chuan Li, MD., PhD.

Role: STUDY_CHAIR

Taipei Medical University

Peisan Lee, MA

Role: STUDY_DIRECTOR

Taipei Medical University

Other Identifiers

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

Identifier Type: -

Identifier Source: org_study_id