Clinical trial NCT02175511: A Randomized Controlled Trial for Hypertension Control by Integrating Cloud BP System and CPOE
Official title: Cloud BP System Integrated With CPOE Improves Self-Management of the Hypertensive Patients: A Randomized Controlled Trial Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Home Blood Pressure
Computerized physician order entry (CPOE)
Telemonitoring
Hypertension
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2014-06-26
Enrollment: 382
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: The proportion of patients with controlled BP (<140/90 mm Hg)
timeFrame: Patients who participated in this trial will be followed for an expected average of 6 months
Secondary outcomes:
measure: The changes in BP and antihypertensive drug prescription
timeFrame: Patients who participated in this trial will be followed for an expected average of 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Taipei Medical University
name: Yu-Chuan Li, MD., PhD.
role: STUDY_CHAIR
affiliation: Taipei Medical University
name: Peisan Lee, MA
role: STUDY_DIRECTOR
References: