NCT02136810

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 13, 2014

Completed
1.5 years until next milestone

Study Start

First participant enrolled

November 9, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2018

Completed
11 months until next milestone

Results Posted

Study results publicly available

December 14, 2018

Completed
Last Updated

June 5, 2023

Status Verified

June 1, 2023

Enrollment Period

1.2 years

First QC Date

May 6, 2014

Results QC Date

November 20, 2018

Last Update Submit

June 1, 2023

Conditions

Hypertension

Keywords

HypertensionPerioperative Care

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.

    Approximately 60 days

  • Preidentified Subgroups

    1 year

  • Patient Perspectives

    60 days

  • Patient Adherence

    60 days

  • Preidentified Subgroup Analysis

    1 year

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale-New Haven Hospital PreAdmission Testing Clinic

New Haven, Connecticut, 06520, United States

Location

Related Publications (3)

  • 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.

    PMID: 26214552BACKGROUND

  • 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.

    PMID: 22075017BACKGROUND

  • 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.

    PMID: 24905036BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Limitations and Caveats

94% of participants returned Home BP cuffs with at least one valid reading.

Results Point of Contact

Title
Dr. Robert Schonberger, PI
Organization
Yale School of Medicine
robert.schonberger@yale.edu
203-785-2802

Study Officials

  • Robert Schonberger, MD/MHS

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2014

First Posted

May 13, 2014

Study Start

November 9, 2015

Primary Completion

January 11, 2017

Study Completion

January 16, 2018

Last Updated

June 5, 2023

Results First Posted

December 14, 2018

Record last verified: 2023-06

Locations

US(1)