Best Rest: Rest Time Before Blood Pressure Measurement Trial
1. september 2022 opdateret af: Johns Hopkins University
Rest Time Before Blood Pressure Measurement Trial
The objectives of this study are to:
- Determine the impact of wait time before initiating BP measurement on BP variability
- Determine the difference in BP variability between measurements by amount of initial rest.
The investigators also aim to:
1. To determine the total time required to obtain a BP measurement.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Detaljeret beskrivelse
Hypertension guidelines recommend a minimum of five minute rest time prior to blood pressure (BP) measurements obtained for screening, diagnosis and management of hypertension.
This recommended wait time is often not adhered to and is cited as a barrier to regular screening due to length of time, clinic workflow and provider burden.
It is unclear if BPs obtained at different rest intervals would provide clinically similar measurements.
This study therefore aims to determine if BPs obtained immediately or after 2 minutes are rest are non-inferior to the BPs obtained after the guideline recommended 5 minutes of rest.
It also aims to determine the time required to measure BP from start to finish, to allow for easier identification of other potential barriers to regular BP screening practices in busy clinical settings.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
116
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Maryland
-
Baltimore, Maryland, Forenede Stater, 21287
- Johns Hopkins School of Medicine Division of Pediatric Nephrology
-
-
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 til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Age 18-80 years
Exclusion Criteria:
- Presence of the following on both arms: rashes, gauze dressings, casts, edema, paralysis, tubes, open sores or wounds, withered arms, A-V shunts, or if blood has been drawn from arm within last week.
- Being mentally impaired, pregnant.
- Arm circumference exceeding 50 cm.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Screening
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: 0-2-5-5 minutes rest group
The order of rest periods for participants randomized to this arm will be: 0 minutes 2 minutes 5 minutes 5 minutes |
Each participant will have 4 sets of 3 blood pressure measurements taken.
The participants will be randomized to the order in which they rest prior to each set of measurements.
|
|
Andet: 0-5-2-5 minutes rest group
The order of rest periods for participants randomized to this arm will be: 0 minutes 5 minutes 2 minutes 5 minutes |
Each participant will have 4 sets of 3 blood pressure measurements taken.
The participants will be randomized to the order in which they rest prior to each set of measurements.
|
|
Andet: 2-0-5-5 minutes rest group
The order of rest periods for participants randomized to this arm will be: 2 minutes 0 minutes 5 minutes 5 minutes |
Each participant will have 4 sets of 3 blood pressure measurements taken.
The participants will be randomized to the order in which they rest prior to each set of measurements.
|
|
Andet: 5-0-2-5 minutes rest group
The order of rest periods for participants randomized to this arm will be: 5 minutes 0 minutes 2 minutes 5 minutes |
Each participant will have 4 sets of 3 blood pressure measurements taken.
The participants will be randomized to the order in which they rest prior to each set of measurements.
|
|
Andet: 2-5-0-5 minutes rest group
The order of rest periods for participants randomized to this arm will be: 2 minutes 5 minutes 0 minutes 5 minutes |
Each participant will have 4 sets of 3 blood pressure measurements taken.
The participants will be randomized to the order in which they rest prior to each set of measurements.
|
|
Andet: 5-2-0-5 minutes rest group
The order of rest periods for participants randomized to this arm will be: 5 minutes 2 minutes 0 minutes 5 minutes |
Each participant will have 4 sets of 3 blood pressure measurements taken.
The participants will be randomized to the order in which they rest prior to each set of measurements.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Difference in Systolic Blood Pressure (mmHg)
Tidsramme: 90 minutes
|
Comparison of the average of 3 systolic BP measurements (mmHg) measured after 5 minutes rest with the average of 3 systolic blood pressure (SBP) measured after the other periods of rest (0 minutes, 2 minutes, second 5 minutes of rest)
|
90 minutes
|
|
Difference in Diastolic Blood Pressure (mmHg)
Tidsramme: 90 minutes
|
Comparison of the average of 3 diastolic BP measurements (mmHg) measured after 5 minutes rest with the average of 3 diastolic blood pressure (DBP) measured after the other periods of rest (0 minutes, 2 minutes, second 5 minutes of rest)
|
90 minutes
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Blood Pressure Variability (mmHg)
Tidsramme: 90 minutes
|
Difference between individual systolic and diastolic BP measurements (BP reading 1 - BP reading 2; BP reading 2 - BP reading 3) obtained per each rest period
|
90 minutes
|
|
Standard Deviation of Blood Pressures (mmHg)
Tidsramme: 90 minutes
|
Difference in standard deviation of the mean of 3 systolic and diastolic BPs obtained at each rest period
|
90 minutes
|
|
Coefficient of Variation of Blood Pressures
Tidsramme: 90 minutes
|
Difference in coefficient of variation (SD/mean) of 3 systolic and diastolic BPs obtained at each rest period
|
90 minutes
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Total time required to obtain a BP measurement (seconds)
Tidsramme: 90 minutes
|
For each rest time assignment, mean time from:
|
90 minutes
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Tammy Brady, MD, PhD, Johns Hopkins University
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.
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 (Faktiske)
11. november 2019
Primær færdiggørelse (Faktiske)
16. marts 2020
Studieafslutning (Faktiske)
16. marts 2020
Datoer for studieregistrering
Først indsendt
22. juli 2019
Først indsendt, der opfyldte QC-kriterier
22. juli 2019
Først opslået (Faktiske)
24. juli 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. september 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. september 2022
Sidst verificeret
1. september 2022
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB00214827
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