Perioperative Blood Pressures and Chronic Hypertension

An observational study of Hypertension, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study aims to assess the performance of presurgical clinic blood pressure measurements in predicting home blood pressure readings among surgical patients. It also aims to measure the association between home blood pressures and patient perspectives on blood pressure control. Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Hypertension
How many people: 200 participants
Where: 1 siteUnited States
Study dates: 9 Nov 2015to 16 Jan 2018
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Ambulatory surgical patients >= 21 years of age presenting for preadmission testing to a tertiary care hospital and who demonstrate elevated clinic blood pressures greater than or equal to 130/85mmHg.

Who may be able to join

Ambulatory patients >= 21 years of age presenting for surgery to a tertiary care preadmission testing clinic.

Who cannot join

Inability or unwillingness to independently operate a home blood pressure monitor.

Trial locations and contacts

1 site in 1 country.

United States1 site

Yale-New Haven Hospital PreAdmission Testing Clinic
New Haven, Connecticut, 06520

Other trials in United States

About this study

Official title: The Association Between Home Blood Pressures and Clinic Blood Pressures in Patients Presenting for Surgery.

Read the detailed description

A convenience sample of presurgical patients seen in a preadmission testing clinic were enrolled and sent home with a home blood pressure monitor that stored up to 50 readings. Participants were asked to return the BP cuff on the day of their surgery.

Conditions: Hypertension
Keywords: Hypertension, Perioperative Care
Medical subject headings: Hypertension

What is being measured

The primary outcome is the main question the study is designed to answer.

Performance of Blood Pressure Referral Threshold
The positive predictive value of preadmission testing-measured blood pressure to predict mean home blood pressure >135/85mmHg will be calculated.
Measured: Subjects followed for approximately 1 year

Secondary outcomes (5)

Patient Perspectives and Beliefs Regarding Blood Pressure Status as They Relate to Actual Home Blood Pressures.
In secondary analyses, the agreement between patients' self-reported blood pressure control (binary outcome) and home blood pressure monitor-determined blood pressure status (binary outcome) will we assessed via Cohen's kappa and raw indices of agreement.
Measured: Approximately 60 days
Preidentified Subgroups
The investigators will examine the correlation between blood pressure and heart rate in the subset of patients with hypertension diagnosis.
Measured: 1 year
Patient Perspectives
The possible association of self-reported availability of primary care (5 point LIKERT scale) with home blood pressure monitor-status will be examined by the Mantel-Haenszel Chi-Square Test.
Measured: 60 days
Patient Adherence
The possible association of medication adherence (Morisky scale) with home blood pressure monitor-status will be examined by the Mantel-Haenszel Chi-Square Test.
Measured: 60 days
Preidentified Subgroup Analysis
The investigators will examine the correlation between blood pressure and heart rate in the subset of patients without hypertension diagnosis.
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Nov 201516 Jan 2018

First posted13 May 2014 (estimated)
Study start9 Nov 2015
Primary completion11 Jan 2017
Study completion16 Jan 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 Yale UniversityThe 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02136810
Sponsor's protocol ID: 1509016399
Other IDs: K23HL116641
Status last verified: Jun 2023
First submitted: 6 May 2014
Last updated: 5 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Schonberger RB, Dai F, Brandt CA, Burg MM. Balancing Model Performance and Simplicity to Predict Postoperative Primary Care Blood Pressure Elevation. Anesth Analg. 2015 Sep;121(3):632-641. doi: 10.1213/ANE.0000000000000860.
PubMed 26214552
Schonberger RB, Burg MM, Holt N, Lukens CL, Dai F, Brandt C. The relationship between preoperative and primary care blood pressure among veterans presenting from home for surgery: is there evidence for anesthesiologist-initiated blood pressure referral? Anesth Analg. 2012 Jan;114(1):205-14. doi: 10.1213/ANE.0b013e318239c4c1. Epub 2011 Nov 10.
PubMed 22075017
Schonberger RB. Ideal blood pressure management and our specialty. J Neurosurg Anesthesiol. 2014 Jul;26(3):270-1. doi: 10.1097/ANA.0000000000000012. No abstract available.
PubMed 24905036

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Association Between Home Blood Pressures and Clinic Blood Pressures in Patients Presenting for Surgery.
ClinicalTrials.gov ID: NCT02136810
Acronym / sponsor ID: 1509016399
Conditions: Hypertension
Keywords: Hypertension, Perioperative Care
Study type: Observational
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Study start: 9 Nov 2015 (actual)
Primary completion: 11 Jan 2017 (actual)
Study completion: 16 Jan 2018 (actual)
First posted: 13 May 2014 (estimated)
Results: Posted 14 Dec 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Ambulatory surgical patients >= 21 years of age presenting for preadmission testing to a tertiary care hospital and who demonstrate elevated clinic blood pressures greater than or equal to 130/85mmHg.

Key inclusion criteria (1 listed)

Ambulatory patients >= 21 years of age presenting for surgery to a tertiary care preadmission testing clinic.

Key exclusion criteria (1 listed)

Inability or unwillingness to independently operate a home blood pressure monitor.

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

Performance of Blood Pressure Referral Threshold
Time frame: Subjects followed for approximately 1 year
The positive predictive value of preadmission testing-measured blood pressure to predict mean home blood pressure >135/85mmHg will be calculated.

5 secondary outcomes

Patient Perspectives and Beliefs Regarding Blood Pressure Status as They Relate to Actual Home Blood Pressures.
Time frame: Approximately 60 days
Preidentified Subgroups
Time frame: 1 year
Patient Perspectives
Time frame: 60 days
Patient Adherence
Time frame: 60 days
Preidentified Subgroup Analysis
Time frame: 1 year

Results and safety

Results posted to the registry on 14 Dec 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Included Participants	200	200

Primary outcome: Performance of Blood Pressure Referral Threshold

Time frame: Subjects followed for approximately 1 year. Number (95% Confidence Interval). Unit: proportion

Measure	Included Participants n = 188
Value	.841 (.78 to .89)

Population analysed: Of the 200 participants, 188 returned Home BP Cuffs with valid BP data.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From time of enrollment until participant returned for surgery.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Included Participants	0 of 200 (0%)	0 of 200 (0%)	0 of 200

Limitations and caveats (from the sponsor): 94% of participants returned Home BP cuffs with at least one valid reading.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 26214552Schonberger RB, Dai F, Brandt CA, Burg MM. Balancing Model Performance and Simplicity to Predict Postoperative Primary Care Blood Pressure Elevation. Anesth Analg. 2015 Sep;121(3):632-641. doi: 10.1213/ANE.0000000000000860.
Background: PubMed 22075017Schonberger RB, Burg MM, Holt N, Lukens CL, Dai F, Brandt C. The relationship between preoperative and primary care blood pressure among veterans presenting from home for surgery: is there evidence for anesthesiologist-initiated blood pressure referral? Anesth Analg. 2012 Jan;114(1):205-14. doi: 10.1213/ANE.0b013e318239c4c1. Epub 2011 Nov 10.
Background: PubMed 24905036Schonberger RB. Ideal blood pressure management and our specialty. J Neurosurg Anesthesiol. 2014 Jul;26(3):270-1. doi: 10.1097/ANA.0000000000000012. No abstract available.

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.

Robert Schonberger, MD/MHS principal investigator

Yale University

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 Yale University 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 1 inclusion and 1 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 5 Jun 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?

Yes. Results are posted in the registry (first posted 14 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Performance of Blood Pressure Referral Threshold (time frame: Subjects followed for approximately 1 year). 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 NCT02136810, 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 5 Jun 2023.