NCT02175511

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
382

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started Dec 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2014

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 26, 2014

Completed
Last Updated

June 26, 2014

Status Verified

June 1, 2012

Enrollment Period

1 year

First QC Date

June 9, 2014

Last Update Submit

June 24, 2014

Conditions

Hypertension

Keywords

Home Blood PressureComputerized physician order entry (CPOE)TelemonitoringHypertension

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • The changes in BP and antihypertensive drug prescription

    Patients who participated in this trial will be followed for an expected average of 6 months

Study Arms (2)

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

Cloud-based home BP monitoringDEVICE

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.

Cloud-based home BP monitoring

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Unable to participate in this trial for the whole process
  • Lived alone and unable to read Text Message

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Yu-Chuan Li, MD., PhD.

    Taipei Medical University

    STUDY CHAIR

  • Peisan Lee, MA

    Taipei Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2014

First Posted

June 26, 2014

Study Start

December 1, 2012

Primary Completion

December 1, 2013

Study Completion

March 1, 2014

Last Updated

June 26, 2014

Record last verified: 2012-06