- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
Ontario
-
North York, Ontario, Canada, M3B 3S6
- North York Family Health Team
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Able to consent
- Over the age of 18
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Case-Crossover
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
---|
All patients over the age of 18
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Automated Blood Pressure measurements in two different environments
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Automated Blood Pressure values of hypertensive patients in two different environments
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Michelle Greiver, MD, North Toronto Primary Care Research Network
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 11-0519
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