Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2026-02-21 @ 6:00 AM
Study NCT ID:
NCT04031768
Status:
COMPLETED
Last Update Posted:
2022-09-06
First Post:
2019-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Best Rest: Rest Time Before Blood Pressure Measurement Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2020-03-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-01', 'studyFirstSubmitDate': '2019-07-22', 'studyFirstSubmitQcDate': '2019-07-22', 'lastUpdatePostDateStruct': {'date': '2022-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Total time required to obtain a BP measurement (seconds)', 'timeFrame': '90 minutes', 'description': 'For each rest time assignment, mean time from:\n\n* Seating -\\> cuff placement\n* Cuff placement -\\> first measurement\n* Start of cuff inflation to measurement completion/BP output on device\n* Overall: Time from seating -\\> completion of all 3 BP measurements, 30 seconds apart.'}], 'primaryOutcomes': [{'measure': 'Difference in Systolic Blood Pressure (mmHg)', 'timeFrame': '90 minutes', 'description': '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)'}, {'measure': 'Difference in Diastolic Blood Pressure (mmHg)', 'timeFrame': '90 minutes', 'description': '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)'}], 'secondaryOutcomes': [{'measure': 'Blood Pressure Variability (mmHg)', 'timeFrame': '90 minutes', 'description': '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'}, {'measure': 'Standard Deviation of Blood Pressures (mmHg)', 'timeFrame': '90 minutes', 'description': 'Difference in standard deviation of the mean of 3 systolic and diastolic BPs obtained at each rest period'}, {'measure': 'Coefficient of Variation of Blood Pressures', 'timeFrame': '90 minutes', 'description': 'Difference in coefficient of variation (SD/mean) of 3 systolic and diastolic BPs obtained at each rest period'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension', 'Blood Pressure', 'Cardiovascular Diseases', 'Cardiovascular Risk Factor']}, 'referencesModule': {'references': [{'pmid': '34601959', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': 'The objectives of this study are to:\n\n1. Determine the impact of wait time before initiating BP measurement on BP variability\n2. Determine the difference in BP variability between measurements by amount of initial rest.\n\nThe investigators also aim to:\n\n1\\. To determine the total time required to obtain a BP measurement.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-80 years\n\nExclusion Criteria:\n\n* 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.\n* Being mentally impaired, pregnant.\n* Arm circumference exceeding 50 cm.'}, 'identificationModule': {'nctId': 'NCT04031768', 'briefTitle': 'Best Rest: Rest Time Before Blood Pressure Measurement Trial', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Rest Time Before Blood Pressure Measurement Trial', 'orgStudyIdInfo': {'id': 'IRB00214827'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '0-2-5-5 minutes rest group', 'description': 'The order of rest periods for participants randomized to this arm will be:\n\n0 minutes 2 minutes 5 minutes 5 minutes', 'interventionNames': ['Other: Timing of rest prior to blood pressure measurement']}, {'type': 'OTHER', 'label': '0-5-2-5 minutes rest group', 'description': 'The order of rest periods for participants randomized to this arm will be:\n\n0 minutes 5 minutes 2 minutes 5 minutes', 'interventionNames': ['Other: Timing of rest prior to blood pressure measurement']}, {'type': 'OTHER', 'label': '2-0-5-5 minutes rest group', 'description': 'The order of rest periods for participants randomized to this arm will be:\n\n2 minutes 0 minutes 5 minutes 5 minutes', 'interventionNames': ['Other: Timing of rest prior to blood pressure measurement']}, {'type': 'OTHER', 'label': '5-0-2-5 minutes rest group', 'description': 'The order of rest periods for participants randomized to this arm will be:\n\n5 minutes 0 minutes 2 minutes 5 minutes', 'interventionNames': ['Other: Timing of rest prior to blood pressure measurement']}, {'type': 'OTHER', 'label': '2-5-0-5 minutes rest group', 'description': 'The order of rest periods for participants randomized to this arm will be:\n\n2 minutes 5 minutes 0 minutes 5 minutes', 'interventionNames': ['Other: Timing of rest prior to blood pressure measurement']}, {'type': 'OTHER', 'label': '5-2-0-5 minutes rest group', 'description': 'The order of rest periods for participants randomized to this arm will be:\n\n5 minutes 2 minutes 0 minutes 5 minutes', 'interventionNames': ['Other: Timing of rest prior to blood pressure measurement']}], 'interventions': [{'name': 'Timing of rest prior to blood pressure measurement', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['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']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins School of Medicine Division of Pediatric Nephrology', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Tammy Brady, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Vital Strategies', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}