HypertensionNCT02175511
A Randomized Controlled Trial for Hypertension Control by Integrating Cloud BP System and CPOE
A study testing Cloud-based home BP monitoring in people with Hypertension, run by Taipei Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Cloud-based home BP monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 382 participants
- Where
- No sites listed yet
- Study dates
- Dec 2012to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Unable to participate in this trial for the whole process
- Lived alone and unable to read Text Message
About this study
Official title: Cloud BP System Integrated With CPOE Improves Self-Management of the Hypertensive Patients: A Randomized Controlled Trial Study
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.
Read the 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
- Being tested
- Cloud-based home BP monitoring
- Keywords
- Home Blood Pressure, Computerized physician order entry (CPOE), Telemonitoring, Hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Cloud-based home BP monitoring | Experimental | 170 were assigned to the experimental group Receives: Device: Cloud-based home BP monitoring |
| Traditional Care | No intervention | 212 patients were assigned to the traditional care group (paper-based data) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with controlled BP (<140/90 mm Hg)
Measured: 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
Measured: Patients who participated in this trial will be followed for an expected average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study startDec 2012
- Primary completionDec 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 382 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
- Investigators
- Yu-Chuan Li, MD., PhD., Study chair, Taipei Medical UniversityPeisan Lee, MA, Study director, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02175511
- Sponsor's protocol ID
- NSC 100-2622-E-038-001-CC2
- Status last verified
- Jun 2012
- First submitted
- 9 Jun 2014
- Last updated
- 26 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cloud BP System Integrated With CPOE Improves Self-Management of the Hypertensive Patients: A Randomized Controlled Trial Study
- ClinicalTrials.gov ID
- NCT02175511
- Acronym / sponsor ID
- NSC 100-2622-E-038-001-CC2
- Conditions
- Hypertension
- Keywords
- Home Blood Pressure, Computerized physician order entry (CPOE), Telemonitoring, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 382 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Dec 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 26 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cloud-based home BP monitoring | Experimental | Device: Cloud-based home BP monitoring170 were assigned to the experimental group |
| Traditional Care | No intervention | –212 patients were assigned to the traditional care group (paper-based data) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Secondary hypertension
- Expectant mother
- Stroke, myocardial infarction or had surgery within 3 months
- Atrial fibrillation
- Inter-arm difference (IAD) >20 mm Hg
Key exclusion criteria (2 listed)
- Unable to participate in this trial for the whole process
- Lived alone and unable to read Text Message
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cloud-based home BP monitoringa 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. | Device | Cloud-based home BP monitoring |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Chuan Li, MD., PhD. study chair
Taipei Medical University
Peisan Lee, MA study director
Taipei Medical University
Questions about this trial
What is this clinical trial studying?
A study testing Cloud-based home BP monitoring in people with Hypertension, run by Taipei Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2014.