Where Should Automated Blood Pressures be Done in Primary Care Offices?

NCT01538004 | Withdrawn

• 1 other identifier: 12-0217
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The use of automated blood pressure measurement (ABPM) devices in the office setting is increasingly recognized as superior to manual BP measurement. Current guidelines recommend that patients be alone in a quiet room, with no interactions with health care professionals during the readings; in practice, this means using an exam room. However, we found no evidence supporting the location of ABPM. Furthermore, exam rooms are constantly being used in primary care offices, so this may not be practical in routine care. For this study, fifty consecutive consenting patients age 18 or more in each of seven community based primary care offices will randomly be allocated to either ABPM in an exam room, or in a non-private area of the clinic. After being tested in the first location they will then be tested in the second location with the same device. The main outcome will be the mean value of the last five systolic blood pressures for each location within offices. Secondary measures will include blood pressures for patients with or without hypertension, a comparison of the initial and second set of blood pressures and of the effect of office noise in decibels on BP readings. New technology is more readily adopted if barriers to use are minimized. If we find no differences in BP readings between office locations, clinicians will then have the option to use an additional office area to implement the automated BP measurement device.

Conditions

Hypertension

Keywords

Blood pressure determination; Primary health care; Office visits; Reproducibility of results

Outcome Measures

Primary Outcomes (1)

• mean value of the last five systolic blood pressures for each location within the offices

  comparison between the mean systolic values of the automated blood pressure measurements using a BpTRU device in private (quiet, no interactions with health care personnel) and non private areas of the offices.

  1 hour

Secondary Outcomes (3)

• comparison of first and second sets of blood pressure readings

  1 hour

• comparisons of automated BP readings for patients with and without previously documented hypertension

  1 hour

• effect of office decibel levels on automated office BP readings

  1 hour

Study Arms (2)

BpTRU readings in private office area

Consenting patients will be randomly allocated using a random number table to BpTRU in an exam room. The first reading will be done with the research assistant present to ensure proper placement and recording and will then be left alone for the subsequent five measurements at one minute intervals. This will be immediately followed by a second set of readings in the alternate location. During both sets of readings the patient will be seated comfortably in a chair with arms and will be instructed not to talk or cross their legs. The same arm will be used for both sets of measurements with the blood pressure cuff at heart level. The average of the last five out of six blood pressure readings for each office location will be recorded. The decibel levels in each location will be recorded during BP readings using a Reed Sound Level Meter C-322. The patient's weight in kg, height in cm, gender and self reported history of hypertension will also be recorded.

BpTRU readings in open office area

Consenting patients will be randomly allocated using a random number table to BpTRU in an open office area The first reading will be done with the research assistant present to ensure proper placement and recording and will then be left alone for the subsequent five measurements at one minute intervals. This will be immediately followed by a second set of readings in the alternate location. During both sets of readings the patient will be seated comfortably in a chair with arms and will be instructed not to talk or cross their legs. The same arm will be used for both sets of measurements with the blood pressure cuff at heart level. The average of the last five out of six blood pressure readings for each office location will be recorded. The decibel levels in each location will be recorded during BP readings using a Reed Sound Level Meter C-322. The patient's weight in kg, height in cm, gender and self reported history of hypertension will also be recorded.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive consenting patients age eighteen or over will be recruited from the waiting rooms of participating practices in Toronto, Ontario

You may qualify if:

• Age eighteen and over
• Able to consent

Sponsors & Collaborators

• North Toronto Primary Care Research Network: lead

Study Sites (1)

North Toronto Primary Care Research Network

Toronto, Ontario, M3B 3S6, Canada

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Michelle Greiver, MD MSc

  North Toronto Primary Care Research Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the North Toronto Primary Care Research Network

Study Record Dates

• First Submitted: February 17, 2012
• First Posted: February 23, 2012
• Study Start: March 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: November 1, 2014
• Last Updated: April 4, 2014

Record last verified: 2014-04

Locations

CA (1)