Clinical trial NCT04031768: Best Rest: Rest Time Before Blood Pressure Measurement Trial
Official title: Rest Time Before Blood Pressure Measurement Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Blood Pressure
Cardiovascular Diseases
Cardiovascular Risk Factor
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Vital Strategies
First posted: 2019-07-24
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Difference in Systolic Blood Pressure (mmHg)
timeFrame: 90 minutes
measure: Difference in Diastolic Blood Pressure (mmHg)
timeFrame: 90 minutes
Secondary outcomes:
measure: Blood Pressure Variability (mmHg)
timeFrame: 90 minutes
measure: Standard Deviation of Blood Pressures (mmHg)
timeFrame: 90 minutes
measure: Coefficient of Variation of Blood Pressures
timeFrame: 90 minutes
Other outcomes:
measure: Total time required to obtain a BP measurement (seconds)
timeFrame: 90 minutes
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Medicine Division of Pediatric Nephrology
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Tammy Brady, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.