A Randomized Controlled Trial for Hypertension Control by... | NCT02175511

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

NCT02175511

Sponsor

Taipei Medical University

Status

Completed

Last Update Posted

Jun 26, 2014Estimated

Enrollment

382Actual

Phase

Not Applicable

Conditions

Hypertension

Interventions

Cloud-based home BP monitoring

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

Dec 2013Actual

Completion Date

Mar 2014Actual

First Submitted Date

Jun 9, 2014

First Submission Date that Met QC Criteria

Jun 24, 2014

First Posted Date

Jun 26, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 24, 2014

Last Update Posted Date

Jun 26, 2014Estimated

Name	Class
National Science and Technology Council, Taiwan	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

382Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yu-Chuan Li, MD., PhD.	Taipei Medical University	Study Chair
Peisan Lee, MA	Taipei Medical University	Study Director

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

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Browse Branches

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