Best Rest: Rest Time Before Blood Pressure Measurement Trial

NCT ID: NCT04031768

Last Updated: 2022-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-11
• Study Completion Date: 2020-03-16

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.

Conditions

Hypertension; Blood Pressure; Cardiovascular Diseases; Cardiovascular Risk Factor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

Timing of rest prior to blood pressure measurement

Intervention Type: OTHER

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.

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

Group Type: OTHER

Timing of rest prior to blood pressure measurement

Intervention Type: OTHER

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.

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

Group Type: OTHER

Timing of rest prior to blood pressure measurement

Intervention Type: OTHER

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.

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

Group Type: OTHER

Timing of rest prior to blood pressure measurement

Intervention Type: OTHER

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.

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

Group Type: OTHER

Timing of rest prior to blood pressure measurement

Intervention Type: OTHER

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.

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

Group Type: OTHER

Timing of rest prior to blood pressure measurement

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vital Strategies

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tammy Brady, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins School of Medicine Division of Pediatric Nephrology

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 34601959 (View on PubMed)

Other Identifiers

IRB00214827

Identifier Type: -

Identifier Source: org_study_id