Best Rest: Rest Time Before Blood Pressure Measurement Trial

Rest Time Before Blood Pressure Measurement Trial

The objectives of this study are to:

1. Determine the impact of wait time before initiating BP measurement on BP variability
2. 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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Hypertension; Blood Pressure; Cardiovascular Risk Factor
• Intervention / Treatment: Other: Timing of rest prior to blood pressure measurement

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins School of Medicine Division of Pediatric Nephrology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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	Other: Timing of rest prior to blood pressure measurement; 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.
Other: 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	Other: Timing of rest prior to blood pressure measurement; 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.
Other: 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	Other: Timing of rest prior to blood pressure measurement; 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.
Other: 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	Other: Timing of rest prior to blood pressure measurement; 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.
Other: 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	Other: Timing of rest prior to blood pressure measurement; 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.
Other: 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	Other: Timing of rest prior to blood pressure measurement; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in Systolic Blood Pressure (mmHg)	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)	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure Variability (mmHg)	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)	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	Difference in coefficient of variation (SD/mean) of 3 systolic and diastolic BPs obtained at each rest period	90 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total time required to obtain a BP measurement (seconds)	For each rest time assignment, mean time from: Seating -> cuff placement; Cuff placement -> first measurement; Start of cuff inflation to measurement completion/BP output on device; Overall: Time from seating -> completion of all 3 BP measurements, 30 seconds apart.	90 minutes

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Vital Strategies
• Investigators: Principal Investigator: Tammy Brady, MD, PhD, Johns Hopkins University

Publications and helpful links

General Publications

• Brady TM, Charleston J, Ishigami J, Miller ER 3rd, Matsushita K, Appel LJ. Effects of Different Rest Period Durations Prior to Blood Pressure Measurement: The Best Rest Trial. Hypertension. 2021 Nov;78(5):1511-1519. doi: 10.1161/HYPERTENSIONAHA.121.17496. Epub 2021 Oct 4.

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2019
• Primary Completion (Actual): March 16, 2020
• Study Completion (Actual): March 16, 2020

Study Registration Dates

• First Submitted: July 22, 2019
• First Submitted That Met QC Criteria: July 22, 2019
• First Posted (Actual): July 24, 2019

Study Record Updates

• Last Update Posted (Actual): September 6, 2022
• Last Update Submitted That Met QC Criteria: September 1, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: IRB00214827

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No