HypertensionNCT00798551
Emergency Department Interventions to Improve Blood Pressure Follow-up
A study testing Risk counseling in people with Hypertension, run by University of Nebraska at 1 site in United States.
Trial summary
Hypertension affects approximately 65 million people in the United States and approximately 20 million individuals remain undiagnosed. In Emergency Room visits, many as one third of the patients were noted to have elevated BP readings, two thirds of which could benefit from further therapy or closer clinic follow-up. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Risk counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2008to 20 Dec 2010
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 19 years of age or older
- diastolic BP 90 mm Hg or systolic BP 140 mm Hg
- diabetes and chronic kidney disease who have a diastolic BP 80 mm Hg or systolic BP 130 mm Hg
Who cannot join
- unable/unwilling to provide informed consent
- acute anxiety state
- Any subject on pain medication which compromises their ability to consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Hypertension affects approximately 65 million people in the United States and approximately 20 million individuals remain undiagnosed. In Emergency Room visits, many as one third of the patients were noted to have elevated BP readings, two thirds of which could benefit from further therapy or closer clinic follow-up. However primary care follow-up after discharge with an elevated BP is surprisingly low. The purpose of this study is to measure the follow-up rate after the Emergency Room visit in individuals identified with elevated blood pressure after a brief counseling regarding risks of elevated blood pressure.
Read the detailed description
Hypertension is a very common disease, affecting approximately 65 million people in the United States. As many as 30 % of people with hypertension, approximately 20 million individuals, remain undiagnosed. As many as one third of patients seen in ED were noted to have elevated BP readings in prior studies. Approximately 5% of emergency department (ED) patients have severely elevated blood pressure. Prior studies suggest that as many as two thirds of ED patients with elevated BP can benefit from further therapy or closer clinic follow-up. However primary care follow-up after ED discharge with an elevated BP is surprisingly low. The purpose of this study is to measure the follow-up rate after the ED visit in individuals identified with elevated blood pressure after a brief counseling regarding risks of elevated blood pressure.
- Conditions
- Hypertension
- Being tested
- Risk counseling
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk counselingBehavioural
cardiovascular risk counseling regarding elevated blood pressure
| Study group | Role | What they receive |
|---|---|---|
| Risk counseling | Other | Risk counseling regarding elevated blood pressure Receives: Behavioral: Risk counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Follow-up with Primary care physician
The purpose of this study is to measure the follow-up rate after the ED visit in individuals identified with elevated blood pressure after a brief counseling regarding risks of elevated blood pressure.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2008 (estimated)
- Study start16 Apr 2008
- Primary completion20 Dec 2010
- Study completion20 Dec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Srikar R Adhikari, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00798551
- Sponsor's protocol ID
- 0519-07-EP
- Status last verified
- Sep 2023
- First submitted
- 25 Nov 2008
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Backer HD, Decker L, Ackerson L. Reproducibility of increased blood pressure during an emergency department or urgent care visit. Ann Emerg Med. 2003 Apr;41(4):507-12. doi: 10.1067/mem.2003.151.
PubMed 12658251Karras DJ, Ufberg JW, Heilpern KL, Cienki JJ, Chiang WK, Wald MM, Harrigan RA, Wald DA, Shayne P, Gaughan J, Kruus LK. Elevated blood pressure in urban emergency department patients. Acad Emerg Med. 2005 Sep;12(9):835-43. doi: 10.1197/j.aem.2005.04.015.
PubMed 16141017Preston RA, Baltodano NM, Cienki J, Materson BJ. Clinical presentation and management of patients with uncontrolled, severe hypertension: results from a public teaching hospital. J Hum Hypertens. 1999 Apr;13(4):249-55. doi: 10.1038/sj.jhh.1000796.
PubMed 10333343
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Department Interventions to Improve Blood Pressure Follow-up
- ClinicalTrials.gov ID
- NCT00798551
- Acronym / sponsor ID
- 0519-07-EP
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 16 Apr 2008 (actual)
- Primary completion
- 20 Dec 2010 (actual)
- Study completion
- 20 Dec 2010 (actual)
- First posted
- 26 Nov 2008 (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.
Hypertension affects approximately 65 million people in the United States and approximately 20 million individuals remain undiagnosed. In Emergency Room visits, many as one third of the patients were noted to have elevated BP readings, two thirds of which could benefit from further therapy or closer clinic follow-up. However primary care follow-up after discharge with an elevated BP is surprisingly low. The purpose of this study is to measure the follow-up rate after the Emergency Room visit in individuals identified with elevated blood pressure after a brief counseling regarding risks of elevated blood pressure.
Detailed description
Hypertension is a very common disease, affecting approximately 65 million people in the United States. As many as 30 % of people with hypertension, approximately 20 million individuals, remain undiagnosed. As many as one third of patients seen in ED were noted to have elevated BP readings in prior studies. Approximately 5% of emergency department (ED) patients have severely elevated blood pressure. Prior studies suggest that as many as two thirds of ED patients with elevated BP can benefit from further therapy or closer clinic follow-up. However primary care follow-up after ED discharge with an elevated BP is surprisingly low. The purpose of this study is to measure the follow-up rate after the ED visit in individuals identified with elevated blood pressure after a brief counseling regarding risks of elevated blood pressure.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Risk counseling | Other | Behavioral: Risk counselingRisk counseling regarding elevated blood pressure |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 19 years of age or older
- diastolic BP 90 mm Hg or systolic BP 140 mm Hg
- diabetes and chronic kidney disease who have a diastolic BP 80 mm Hg or systolic BP 130 mm Hg
Key exclusion criteria (3 listed)
- unable/unwilling to provide informed consent
- acute anxiety state
- Any subject on pain medication which compromises their ability to consent
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 |
|---|---|---|
| Risk counselingcardiovascular risk counseling regarding elevated blood pressure | Behavioural | Risk counseling |
Primary outcome
Follow-up with Primary care physician
Time frame: one month
The purpose of this study is to measure the follow-up rate after the ED visit in individuals identified with elevated blood pressure after a brief counseling regarding risks of elevated blood pressure.
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 15 Sep 2023.
- Results publication: PubMed 12658251Backer HD, Decker L, Ackerson L. Reproducibility of increased blood pressure during an emergency department or urgent care visit. Ann Emerg Med. 2003 Apr;41(4):507-12. doi: 10.1067/mem.2003.151.
- Results publication: PubMed 16141017Karras DJ, Ufberg JW, Heilpern KL, Cienki JJ, Chiang WK, Wald MM, Harrigan RA, Wald DA, Shayne P, Gaughan J, Kruus LK. Elevated blood pressure in urban emergency department patients. Acad Emerg Med. 2005 Sep;12(9):835-43. doi: 10.1197/j.aem.2005.04.015.
- Results publication: PubMed 10333343Preston RA, Baltodano NM, Cienki J, Materson BJ. Clinical presentation and management of patients with uncontrolled, severe hypertension: results from a public teaching hospital. J Hum Hypertens. 1999 Apr;13(4):249-55. doi: 10.1038/sj.jhh.1000796.
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
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.
Srikar R Adhikari, MD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Risk counseling in people with Hypertension, run by University of Nebraska 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 3 inclusion and 3 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 15 Sep 2023. 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?
Follow-up with Primary care physician (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00798551, which also lists 3 linked publications.
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 15 Sep 2023.