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Blood Pressure Checks for Diagnosing Hypertension (BP-CHECK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03130257
Recruitment Status : Completed
First Posted : April 26, 2017
Results First Posted : November 16, 2020
Last Update Posted : November 16, 2020
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Kaiser Permanente

Brief Summary:

Hypertension is usually diagnosed at a clinic or doctor's office when a patient has blood pressure (BP) that is high for several measurements. However, about 30 percent of patients with high BP in clinics have normal BP outside of clinics. This is called white-coat hypertension. Correct diagnosis of hyper-tension is important to prevent strokes, heart attacks, and heart failure but also to avoid making people worry or take medicines when they don't need to.

To avoid misdiagnosis of hypertension, the US Preventive Services Task Force (USPSTF), which makes national recommendations about disease screening, recommends people should have 24-hour BP ambulatory monitoring (i.e., an arm cuff and BP monitor worn for 24 hours, with measurements taken every 30 minutes during the day and every 60 minutes at night), with home BP monitoring over several days as an alternative. However, most patients have never heard of 24-hour BP monitoring, and physicians rarely order it. Physicians sometimes use home BP monitoring, but not according to recommended guidelines. BP kiosks, for example at drug stores, offer another option. Newer models are accurate and easy to use.

BP-CHECK will identify participants, ages 18 to 85, with high BP at their last clinic visit and invite them to a screening visit. Participants with high BP at the screening visit (510 patients) will be randomized and assigned to 1) clinic BP, 2) home BP, or 3) kiosk BP diagnostic groups for confirming a new diagnosis of hypertension. The clinic BP group will have BP measured at one clinic visit. The home BP group will measure BP two times, twice a day, for five days. The kiosk BP group will measure BP three times on three separate days at a kiosk at their clinic or nearby drugstore. Participants will complete their diagnostic tests over approximately three weeks. They will then be asked to complete 24-hour BP monitoring. Participants will complete surveys at baseline prior to randomization, after diagnostic tests, and at six months.

Hypothesis 1: Compared to the reference standard (24-hour BP), home BP and kiosk BP will be more accurate than clinic BP. Hypothesis 2: Participants with clinic, home, or kiosk BP results concordant with reference standard results will prefer home or kiosk to clinic and 24-hour BP. Hypothesis 2: Participants with clinic, home, or kiosk BP results concordant with reference standard results will prefer home or kiosk to clinic and 24-hour BP.


Condition or disease Intervention/treatment Phase
Blood Pressure Diagnostic Test: Clinic Blood Pressure Measurement Diagnostic Test: Home Blood Pressure Measurement Diagnostic Test: Kiosk Blood Pressure Measurement Diagnostic Test: 24-hour Ambulatory Blood Pressure Monitoring (Reference Standard) Not Applicable

Detailed Description:

The investigators will compare the accuracy and acceptability (i.e., comfort, convenience) of clinic, home, and kiosk BP testing to 24-hour BP ambulatory monitoring. The investigators will look at the impact of the study on outcomes that matter to participants: their BP and whether participants feel better or worse overall, worry about BP, and change health behaviors (e.g., lowering salt intake).

Our study team includes patients. The study team also has patient and stakeholder advisors to ensure our study is conducted properly and is not a burden to patients and providers. The investigators will share study results with patient participants and publish papers in scientific journals.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 510 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Blood Pressure Checks for Diagnosing Hypertension (BP-CHECK)
Actual Study Start Date : May 11, 2017
Actual Primary Completion Date : August 26, 2019
Actual Study Completion Date : August 26, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Clinic Blood Pressure Measurement
Participants will be asked to check their blood pressure at their clinic once within the subsequent three weeks.
Diagnostic Test: Clinic Blood Pressure Measurement
Participants will be asked to check their blood pressure once within the subsequent three weeks.

Diagnostic Test: 24-hour Ambulatory Blood Pressure Monitoring (Reference Standard)
Participants will be asked to wear an arm cuff and ambulatory blood pressure monitor for 24 hours, with measurements taken every 30 minutes during the day and every 60 minutes at night.

Active Comparator: Home Blood Pressure Measurement
Participants will receive a validated upper-arm home blood pressure monitor and asked to take two measurements in the morning and two in the evening for at least 5 days over three weeks.
Diagnostic Test: Home Blood Pressure Measurement
Participants will receive a validated upper-arm home blood pressure monitor and asked to two measurements in the morning and two in the evening for at least 5 days over three weeks.

Diagnostic Test: 24-hour Ambulatory Blood Pressure Monitoring (Reference Standard)
Participants will be asked to wear an arm cuff and ambulatory blood pressure monitor for 24 hours, with measurements taken every 30 minutes during the day and every 60 minutes at night.

Active Comparator: Kiosk Blood Pressure Measurement
Participants will be asked to use a validated blood pressure kiosk in their clinic or local pharmacy to measure their blood pressure three times on three separate days over three weeks.
Diagnostic Test: Kiosk Blood Pressure Measurement
Participants will be asked to use a validated blood pressure kiosk in their clinic or local pharmacy to measure their blood pressure three times on three separate days over three weeks.

Diagnostic Test: 24-hour Ambulatory Blood Pressure Monitoring (Reference Standard)
Participants will be asked to wear an arm cuff and ambulatory blood pressure monitor for 24 hours, with measurements taken every 30 minutes during the day and every 60 minutes at night.




Primary Outcome Measures :
  1. Comparative Performance of Clinic, Home, and Kiosk [ Time Frame: Randomization to three weeks ]
    To compare the performance of clinic, home, and kiosk blood pressure to 24-hour blood pressure (reference standard) for new hypertension diagnoses. Our primary outcome is differences in mean systolic and diastolic blood pressure comparing clinic, home, and kiosk to 24-hour BP.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • enrolled in the health plan for two years, no diagnosis of hypertension in the prior 2 years or more,
  • not on anti-hypertensive medications,
  • a high blood pressure at their last clinic visit (systolic blood pressure > or equal to 140 mm Hg or diastolic blood pressure > or equal to 90,
  • planning to remain a Kaiser Permanente patient for the next six months,
  • able to converse and read in English,
  • required to have elevated blood pressure at the screening visit (BP taken 2 times, high each time).

Exclusion Criteria:

  • children and pregnant women,
  • patients with end-stage renal disease,
  • dementia,
  • atrial fibrillation and other significant arrhythmias.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03130257


Locations
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United States, Washington
Kaiser Permanente Washington
Seattle, Washington, United States, 98023
Sponsors and Collaborators
Kaiser Permanente
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Beverly B Green, MD, MPH Kaiser Permanente
  Study Documents (Full-Text)

Documents provided by Kaiser Permanente:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT03130257    
Other Study ID Numbers: CER-1511-32979
First Posted: April 26, 2017    Key Record Dates
Results First Posted: November 16, 2020
Last Update Posted: November 16, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: A final de-identified data set will be made available to the Patient-Centered Outcome Research Institute (PCORI). This data set will include de-identified, individual-level data and meet specifications set by our Institutional Review Board for sharing such data. The analytic data set will include data dictionaries and descriptions of the data such as cohort identification, study participant characteristics, and data captured electronically and via patient surveys. Parties may request data from Dr. Beverly Green and will need to indicate their plans for data use, acknowledge the source of the data in publications, and, if possible, collaborate with BP-CHECK research group.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kaiser Permanente:
blood pressure measurement
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases