HypertensionNCT04031768
Best Rest: Rest Time Before Blood Pressure Measurement Trial
A study testing Timing of rest prior to blood pressure measurement in people with Hypertension and Blood Pressure, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Blood Pressure, Cardiovascular Diseases
- What is being tested?
- Timing of rest prior to blood pressure measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2019to 16 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-80 years
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins School of Medicine Division of Pediatric Nephrology
Baltimore, Maryland, 21287
About this study
Official title: 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:
- To determine the total time required to obtain a BP measurement.
Read the 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.
- Being tested
- Timing of rest prior to blood pressure measurement
- Medical subject headings
- Hypertension, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timing of rest prior to blood pressure measurementOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 0-2-5-5 minutes rest group | Other | The order of rest periods for participants randomized to this arm will be:
0 minutes 2 minutes 5 minutes 5 minutes Receives: Other: Timing of rest prior to blood pressure measurement |
| 0-5-2-5 minutes rest group | Other | The order of rest periods for participants randomized to this arm will be:
0 minutes 5 minutes 2 minutes 5 minutes Receives: Other: Timing of rest prior to blood pressure measurement |
| 2-0-5-5 minutes rest group | Other | The order of rest periods for participants randomized to this arm will be:
2 minutes 0 minutes 5 minutes 5 minutes Receives: Other: Timing of rest prior to blood pressure measurement |
| 5-0-2-5 minutes rest group | Other | The order of rest periods for participants randomized to this arm will be:
5 minutes 0 minutes 2 minutes 5 minutes Receives: Other: Timing of rest prior to blood pressure measurement |
| 2-5-0-5 minutes rest group | Other | The order of rest periods for participants randomized to this arm will be:
2 minutes 5 minutes 0 minutes 5 minutes Receives: Other: Timing of rest prior to blood pressure measurement |
| 5-2-0-5 minutes rest group | Other | The order of rest periods for participants randomized to this arm will be:
5 minutes 2 minutes 0 minutes 5 minutes Receives: Other: Timing of rest prior to blood pressure measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 90 minutes
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study start11 Nov 2019
- Primary completion16 Mar 2020
- Study completion16 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Vital Strategies
- Responsible party
- Sponsor
- Investigators
- Tammy Brady, MD, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04031768
- Sponsor's protocol ID
- IRB00214827
- Status last verified
- Sep 2022
- First submitted
- 22 Jul 2019
- Last updated
- 6 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34601959
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rest Time Before Blood Pressure Measurement Trial
- ClinicalTrials.gov ID
- NCT04031768
- Acronym / sponsor ID
- IRB00214827
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Vital Strategies
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 16 Mar 2020 (actual)
- Study completion
- 16 Mar 2020 (actual)
- First posted
- 24 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 0-2-5-5 minutes rest group | Other | Other: Timing of rest prior to blood pressure measurementThe order of rest periods for participants randomized to this arm will be: 0 minutes 2 minutes 5 minutes 5 minutes |
| 0-5-2-5 minutes rest group | Other | Other: Timing of rest prior to blood pressure measurementThe order of rest periods for participants randomized to this arm will be: 0 minutes 5 minutes 2 minutes 5 minutes |
| 2-0-5-5 minutes rest group | Other | Other: Timing of rest prior to blood pressure measurementThe order of rest periods for participants randomized to this arm will be: 2 minutes 0 minutes 5 minutes 5 minutes |
| 5-0-2-5 minutes rest group | Other | Other: Timing of rest prior to blood pressure measurementThe order of rest periods for participants randomized to this arm will be: 5 minutes 0 minutes 2 minutes 5 minutes |
| 2-5-0-5 minutes rest group | Other | Other: Timing of rest prior to blood pressure measurementThe order of rest periods for participants randomized to this arm will be: 2 minutes 5 minutes 0 minutes 5 minutes |
| 5-2-0-5 minutes rest group | Other | Other: Timing of rest prior to blood pressure measurementThe order of rest periods for participants randomized to this arm will be: 5 minutes 2 minutes 0 minutes 5 minutes |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18-80 years
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Timing of rest prior to blood pressure measurementEach 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 | 0-2-5-5 minutes rest group, 0-5-2-5 minutes rest group, 2-0-5-5 minutes rest group, 2-5-0-5 minutes rest group, 5-0-2-5 minutes rest group, 5-2-0-5 minutes rest group |
Primary outcome
Difference in Systolic Blood Pressure (mmHg)
Time frame: 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)
Difference in Diastolic Blood Pressure (mmHg)
Time frame: 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)
3 secondary outcomes
Blood Pressure Variability (mmHg)
Time frame: 90 minutes
Standard Deviation of Blood Pressures (mmHg)
Time frame: 90 minutes
Coefficient of Variation of Blood Pressures
Time frame: 90 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2022.
- Results publication: PubMed 34601959Brady 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tammy Brady, MD, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Timing of rest prior to blood pressure measurement in people with Hypertension and Blood Pressure, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Systolic Blood Pressure (mmHg) (time frame: 90 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04031768, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2022.