NCT03634813

Brief Summary

To explore in a pilot randomized clinical trial, the impact of Home Blood Pressure Monitoring with patient directed information as compared to usual care on the postoperative management of blood pressure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

Typical duration for not_applicable

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

August 10, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 16, 2018

Completed
15 days until next milestone

Study Start

First participant enrolled

August 31, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2021

Completed
1 month until next milestone

Results Posted

Study results publicly available

May 24, 2021

Completed
Last Updated

November 17, 2022

Status Verified

November 1, 2022

Enrollment Period

1.7 years

First QC Date

August 10, 2018

Results QC Date

April 30, 2021

Last Update Submit

November 11, 2022

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (2)

  • Patients Reporting Primary Care Follow-up

    For the primary analysis, we will estimate the proportion of subjects that had a primary care follow-up visit within 60 days

    60 days

  • Patients Reporting New/Adjusted Hypertension Treatment.

    For the primary analysis, we will estimate the proportion reporting new/adjusted hypertension treatment within 60 days. The count of participants is the number of patients for whom it was determined that they had new or adjusted hypertension treatment.

    60 days

Secondary Outcomes (1)

  • Patient Acceptance/Satisfaction With Blood Pressure Care

    60 days

Other Outcomes (1)

  • Patients Demonstrating HBPM Elevation.

    1 year

Study Arms (2)

High Blood Pressure Monitoring and Counseling

EXPERIMENTAL

Enrolled patients will be fitted with a HBPM device and instructed in its use. Patients will be asked to return the HBPM device on the morning of surgery. At the same time they receive the HBPM device, they will also be provided with the National Institutes of Health (NIH) booklet called "Your guide on lowering blood pressure", which has several guidelines regarding diet, exercise and lifestyle changes that can be implemented to improve blood pressure control.

Device: High Blood Pressure Monitor

Usual Care

ACTIVE COMPARATOR

The usual care group will receive brief counseling after the PAT visit which will review their blood pressure readings taken at the clinic and how they compare with the American Heart Association (AHA) blood pressure guidelines. They will be offered the suggestion that they should follow up with their primary care doctor 2-4 weeks after their surgical episode is completed, or at their earliest convenience.

Procedure: Usual Care

Interventions

High Blood Pressure MonitorDEVICE

High Blood Pressure Monitoring device (Omron MX3 model BP742, Omron, Shaumberg, IL)

High Blood Pressure Monitoring and Counseling
Usual CarePROCEDURE

Usual Care

Usual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • We propose to recruit patients who present for ambulatory surgery, aged \>18 years, with a preoperative blood pressure \> 140/90 mmHg taken as the mean of two readings during the pre-admission testing visit.

You may not qualify if:

  • Patients who are unable or unwilling to be contacted by telephone, are non-English speaking, or are unable to operate an automated home blood pressure monitor will also be excluded.
  • Healthy patients with blood pressure readings that fall within the American Heart Association (AHA) guidelines.

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 (1)

  • Diaz SI, Yan L, Dai F, Zhou B, Burg MM, Schonberger RB. Feasibility of a randomized hypertension screening initiative in the perioperative setting. Perioper Med (Lond). 2021 Nov 22;10(1):39. doi: 10.1186/s13741-021-00210-7.

    PMID: 34802471DERIVED

Results Point of Contact

Title
Robert B. Schonberger, Director of Clinical Scientist Track Program
Organization
Yale School of Medicine
robert.schonberger@yale.edu
203-785-3941

Study Officials

  • Robert Schonberger, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: 2 cohort parallel
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2018

First Posted

August 16, 2018

Study Start

August 31, 2018

Primary Completion

May 1, 2020

Study Completion

April 17, 2021

Last Updated

November 17, 2022

Results First Posted

May 24, 2021

Record last verified: 2022-11

Locations

US(1)