Alberta Clinical Trial in Optimizing Hypertension (RxAction)
25. april 2015 opdateret af: Ross T. Tsuyuki, University of Alberta
Alberta Clinical Trial in Optimizing Hypertension: The RxAction Study
The purpose of this study is to evaluate the effect of enhanced pharmacist care (patient identification, assessment, education, prescribing/titration of antihypertensive medications and close follow-up) on systolic blood pressure (BP) reduction in patients with poorly controlled hypertension in the community setting.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The study is a randomized, controlled trial of enhanced pharmacist care, with the unit of randomization as the patient.
Participants will be randomized to enhanced pharmacist care (patient identification, assessment, education, close follow-up and prescribing/titration of antihypertensive medications or usual care.
Participants will be patients in Alberta with undiagnosed or uncontrolled BP as defined by the Canadian Hypertension Education Program.
The primary intervention will be enhanced pharmacist care.
Pharmacists will assess patients with regards to cardiovascular risk reduction including reviewing BP control, treatment goals and determining lifestyle modifications for the patient to undertake to help manage their BP.
The primary outcome will be a comparison of difference in change in systolic BP between enhanced care and usual care at 24 weeks follow-up.
Secondary outcomes include the number of patients at their BP target at 24 weeks, number of new antihypertensive medication starts, number of antihypertensive dosage changes, number of antihypertensive medication changes and number of new prescriptions for ASA and cholesterol medications.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
248
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Alberta
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Edmonton, Alberta, Canada, T6G 2C8
- University of Alberta
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Overall average (after 2 visits) systolic ≥180 OR diastolic ≥110 mmHg in undiagnosed patients without macrovascular target organ damage, diabetes or chronic kidney disease
- Overall average (after 2 visits) systolic ≥140 OR diastolic ≥90 for patients with undiagnosed hypertension with macrovascular target organ damage (coronary artery disease, cerebrovascular disease, DM)
- In patients with diagnosed hypertension, systolic ≥140 (≥ 130 with DM or CKD) OR diastolic ≥90, (≥ 80 with DM or CKD)
- Overall average (after 5 visits, for those without macrovascular target organ damage, DM, or CKD and without an existing hypertension diagnosis) systolic ≥140 OR diastolic ≥90 mmHg
- Overall average (after 7 days of twice-daily home blood pressure monitoring , for those without macrovascular target organ damage, DM, or CKD and without an existing hypertension diagnosis) systolic ≥135 OR diastolic ≥85
Exclusion Criteria:
Patients with hypertensive urgency or emergency:
- Urgency: SBP ≥ 180 mm Hg or DBP ≥ 120 mm Hg with no acute signs of end-organ damage
- Unwilling to participate/sign consent form
- Pregnancy
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Sædvanlig pleje
|
Patients randomized to usual care will receive a wallet card for BP readings, pamphlet on BP and usual pharmacist and physician care.
Patients will be seen at 12 weeks for interim BP measurement only.
Both groups of patients will be seen at 24 weeks for BP measurement.
Andre navne:
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Eksperimentel: Enhanced pharmacist care
|
The primary intervention will be enhanced pharmacist care.
Pharmacists will assess patients with regards to cardiovascular risk reduction including reviewing BP control, treatment goals and determining lifestyle modifications for the patient to undertake to help manage their BP.
The pharmacist will also review the patient's current hypertensive therapy regimen and decide on the options for improvement of BP control (lifestyle modification, increase dose, additional BP medications), and implementation of these strategies.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Comparison of difference in change in systolic BP between enhanced care and usual care
Tidsramme: 24 weeks
|
24 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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number of patients at their BP target
Tidsramme: 24 weeks
|
24 weeks
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number of new antihypertensive medication starts
Tidsramme: 24 weeks
|
24 weeks
|
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number of antihypertensive dosage changes
Tidsramme: 24 weeks
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24 weeks
|
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EQ-5D
Tidsramme: 24 weeks
|
24 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Ross T. Tsuyuki, PharmD, MSc, University of Alberta
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Tsuyuki RT, Houle SK, Charrois TL, Kolber MR, Rosenthal MM, Lewanczuk R, Campbell NR, Cooney D, McAlister FA; RxACTION Investigators*. Randomized Trial of the Effect of Pharmacist Prescribing on Improving Blood Pressure in the Community: The Alberta Clinical Trial in Optimizing Hypertension (RxACTION). Circulation. 2015 Jul 14;132(2):93-100. doi: 10.1161/CIRCULATIONAHA.115.015464. Epub 2015 Jun 10.
- Charrois TL, McAlister FA, Cooney D, Lewanczuk R, Kolber MR, Campbell NR, Rosenthal M, Houle SK, Tsuyuki RT. Improving hypertension management through pharmacist prescribing; the rural Alberta clinical trial in optimizing hypertension (Rural RxACTION): trial design and methods. Implement Sci. 2011 Aug 11;6:94. doi: 10.1186/1748-5908-6-94.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. november 2009
Primær færdiggørelse (Faktiske)
1. november 2013
Studieafslutning (Faktiske)
1. marts 2014
Datoer for studieregistrering
Først indsendt
8. april 2009
Først indsendt, der opfyldte QC-kriterier
8. april 2009
Først opslået (Skøn)
9. april 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
28. april 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. april 2015
Sidst verificeret
1. april 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Pro00005300
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .