HypertensionNCT02217059
Emergency Department Home Blood Pressure Monitoring and BpTRU Study
An observational study of Hypertension, run by Rhode Island Hospital at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the Congruence of Emergency Department (ED) Attendings' Predictions of Hypertension with Results of Home Blood Pressure Monitoring. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Jul 2017
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Emergency Department
Who may be able to join
- One elevated blood pressure greater than 120 systolic and/or 80 diastolic
- BpTRU device blood pressure greater than 120 systolic and/or 80 diastolic while in ED
Who cannot join
- Prior history of hypertension
- Currently on antihypertensives or receiving prescription on discharge
- Pregnancy
- History of atrial fibrillation
- Dialysis patient
- Nursing home or rehabilitation center resident
Show all 15Show fewer
- Admitted
- Moving out of the area in next 30 days
- Substance abuse
- Prisoner
- Presenting for psychiatric complaint requiring constant observation
- Inability to give informed consent (intoxicated, altered, non-English speaking)
- Presenting with symptoms of hypertensive emergency
- Inability to demonstrate adequate use of the home blood pressure device in the ED
- Arm circumference less than 9 inches or greater than 17 inches
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
Official title: Congruence of Emergency Department Attendings' Predictions of Hypertension With Results of Home Blood Pressure Monitoring
The purpose of this study is to evaluate the Congruence of Emergency Department (ED) Attendings' Predictions of Hypertension with Results of Home Blood Pressure Monitoring.
Read the detailed description
Evaluate the Congruence of Emergency Department (ED) Attendings' Predictions of Hypertension with Results of Home Blood Pressure Monitoring \& evaluate reliability of ED measured elevated blood pressure compared to the BpTRU
- Conditions
- Hypertension
- Keywords
- Emergency Medical Services, Emergency Care, Hypertension, BpTRU, Blood pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prehypertension | Using the JNC7 definition | |
| Stage I Hypertension | Using the JNC7 definition | |
| Stage II Hypertension | Using the JNC7 definition |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of emergency department attendings that accurately predict which patients meet criteria for hypertension in two week follow-up using home blood pressure monitoring.
Measured: 18 months
Secondary outcomes (1)
The predictive value of the emergency department measured blood pressure by the standard ED blood pressure device, BpTRU device, and home blood pressure device for hypertension in follow-up
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionJul 2017
- Study completionJul 2017
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02217059
- Sponsor's protocol ID
- UEMF0000
- Status last verified
- Mar 2016
- First submitted
- 7 Aug 2014
- Last updated
- 29 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Congruence of Emergency Department Attendings' Predictions of Hypertension With Results of Home Blood Pressure Monitoring
- ClinicalTrials.gov ID
- NCT02217059
- Acronym / sponsor ID
- UEMF0000
- Conditions
- Hypertension
- Keywords
- Emergency Medical Services, Emergency Care, Hypertension, BpTRU, Blood pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 15 Aug 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.
The purpose of this study is to evaluate the Congruence of Emergency Department (ED) Attendings' Predictions of Hypertension with Results of Home Blood Pressure Monitoring.
Detailed description
Evaluate the Congruence of Emergency Department (ED) Attendings' Predictions of Hypertension with Results of Home Blood Pressure Monitoring \& evaluate reliability of ED measured elevated blood pressure compared to the BpTRU
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prehypertension | – | –Using the JNC7 definition |
| Stage I Hypertension | – | –Using the JNC7 definition |
| Stage II Hypertension | – | –Using the JNC7 definition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Emergency Department
Key inclusion criteria (2 listed)
- One elevated blood pressure greater than 120 systolic and/or 80 diastolic
- BpTRU device blood pressure greater than 120 systolic and/or 80 diastolic while in ED
Key exclusion criteria (15 listed)
- Prior history of hypertension
- Currently on antihypertensives or receiving prescription on discharge
- Pregnancy
- History of atrial fibrillation
- Dialysis patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The percentage of emergency department attendings that accurately predict which patients meet criteria for hypertension in two week follow-up using home blood pressure monitoring.
Time frame: 18 months
1 secondary outcome
The predictive value of the emergency department measured blood pressure by the standard ED blood pressure device, BpTRU device, and home blood pressure device for hypertension in follow-up
Time frame: 18 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 29 Nov 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Rhode Island Hospital at 1 site in United States.
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 2 inclusion and 15 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 29 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 percentage of emergency department attendings that accurately predict which patients meet criteria for hypertension in two week follow-up using home blood pressure monitoring. (time frame: 18 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 29 Nov 2017.