- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT01357226
Using the Blood Pressure TRU in Clinical Settings: a Knowledge Translation Study
Using the Bp TRU in Clinical Settings: a Knowledge Translation Study
Context: Use of automated blood pressure (BP) measurement devices in the office setting is increasingly recognized as superior to manual BP measurement. Current recommendations are to have the patient alone in a quiet room, with no interactions with health care professionals during the readings. However, this may not be practical in primary care offices where the exam rooms are constantly being used.
Objective: To compare measurements with an automated BP device in private examination rooms with measurements in non-private areas of a primary care office.
Design: Randomized controlled trial with cross-over.
Setting: Community based primary care office participating in the NorTReN Practice Based Research Network in Toronto, Ontario.
Participants: Fifty consecutive consenting patients over the age of 18 having their BP checked as part of their routine care.
Intervention: Patients will be randomly allocated to either automated BP measurement in an exam room, or in a non-private area of the clinic. After being tested in the first location they will subsequently be tested in the second location with the same device.
Main outcome measure: The primary outcome measure is a comparison between the mean systolic values of the automated BP measurements in the two office areas. The investigators will use the t-test for paired samples. The secondary outcome is a comparison of systolic values for patients with previously documented hypertension. The investigators define a clinically meaningful result as a difference of 5 mmHg or more in systolic BP.
Conclusion: New technology is more readily adopted if barriers to use are minimized. If the investigators find no differences in BP readings between office locations, physicians will then have the convenience of an additional office area to implement the automated BP measurement device.
Studie Overzicht
Toestand
Conditie
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
-
-
Ontario
-
North York, Ontario, Canada, M3B 3S6
- North York Family Health Team
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- Able to consent
- Over the age of 18
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: Geval-overgang
- Tijdsperspectieven: Prospectief
Cohorten en interventies
Groep / Cohort |
---|
All patients over the age of 18
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Automated Blood Pressure measurements in two different environments
Tijdsspanne: Day of consent
|
Comparison of the mean systolic values of the automated blood pressure measurement in the private exam room and the common area (laboratory area).
|
Day of consent
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Automated Blood Pressure values of hypertensive patients in two different environments
Tijdsspanne: Day of consent
|
Comparison of the mean systolic blood pressure measurements for patients with previously documented hypertension in the private exam room and the common area (laboratory area).
|
Day of consent
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Michelle Greiver, MD, North Toronto Primary Care Research Network
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- 11-0519
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .