NCT03460249

Brief Summary

The investigators plan to determine if the sequence of blood pressure measurements from the sitting position to the table and vice versa has an impact on the measurements.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2018

Shorter than P25 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

October 18, 2017

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 9, 2018

Completed
24 days until next milestone

Study Start

First participant enrolled

April 2, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

September 5, 2018

Status Verified

September 1, 2018

Enrollment Period

3 months

First QC Date

October 18, 2017

Last Update Submit

September 2, 2018

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (1)

  • Percentage of participants whose blood pressures differ with chair to table versus table to chair positioning

    Chair to table versus table to chair positional differences in mean systolic and diastolic blood pressures in mm Hg are determined for each participant using an oscillometric device. The percentage of individuals with significant differences in positional blood pressure readings leading to inconsistent blood pressure health status classification will be calculated and reported.

    4 months

Study Arms (2)

BP table or chair, systolic or diastolic

ACTIVE COMPARATOR

record the BP obtained in each patient position

Other: BP measurement

as above

ACTIVE COMPARATOR

as above

Other: BP measurement

Interventions

BP measurementOTHER

the BP will be measured in the chair position followed by the table position and also in the reverse sequence

BP table or chair, systolic or diastolicas above

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients presenting to the Family Medicine Center age between 18 and 80

You may not qualify if:

  • Decline to participate for any reason
  • Experiencing acute pain or febrile illness
  • Pregnant
  • Inability to get on the examination table
  • Atrial fibrillation, arrhythmia or tachycardia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mercy Health Youngstown

Youngstown, Ohio, 44501, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Associate Professor of Family and Community Medicine

Study Record Dates

First Submitted

October 18, 2017

First Posted

March 9, 2018

Study Start

April 2, 2018

Primary Completion

July 2, 2018

Study Completion

August 1, 2018

Last Updated

September 5, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)