Blood Pressure Checks for Diagnosing Hypertension (BP-CHECK)

NCT03130257 | Completed Results DMC

• 1 other identifier: CER-1511-32979
• Study Type: interventional
• Target: 510
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure

Keywords

blood pressure measurement

Outcome Measures

Primary Outcomes (1)

• Comparative Performance of Clinic, Home, and Kiosk

  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.

  Randomization to three weeks

Study Arms (3)

Clinic Blood Pressure Measurement

ACTIVE COMPARATOR

Participants will be asked to check their blood pressure at their clinic once within the subsequent three weeks.

Diagnostic Test: Clinic Blood Pressure Measurement; Diagnostic Test: 24-hour Ambulatory Blood Pressure Monitoring (Reference Standard)

Home Blood Pressure Measurement

ACTIVE COMPARATOR

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; Diagnostic Test: 24-hour Ambulatory Blood Pressure Monitoring (Reference Standard)

Kiosk Blood Pressure Measurement

ACTIVE COMPARATOR

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; Diagnostic Test: 24-hour Ambulatory Blood Pressure Monitoring (Reference Standard)

Interventions

Clinic Blood Pressure Measurement DIAGNOSTIC_TEST

Participants will be asked to check their blood pressure once within the subsequent three weeks.

Clinic Blood Pressure Measurement

Home Blood Pressure Measurement DIAGNOSTIC_TEST

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.

Home Blood Pressure Measurement

Kiosk Blood Pressure Measurement DIAGNOSTIC_TEST

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.

Kiosk Blood Pressure Measurement

24-hour Ambulatory Blood Pressure Monitoring (Reference Standard) DIAGNOSTIC_TEST

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.

Clinic Blood Pressure Measurement; Home Blood Pressure Measurement; Kiosk Blood Pressure Measurement

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Kaiser Permanente: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Kaiser Permanente Washington

Seattle, Washington, 98023, United States

Location

Related Publications (7)

• Hansell LD, Hsu CW, Munson SA, Margolis KL, Thompson MJ, Ehrlich KJ, Hall YN, Anderson ML, Evers SC, Marcus-Smith MS, McClure JB, Green BB. Patient Experiences With Blood Pressure Measurement Methods for Hypertension Diagnosis: Qualitative Findings From the BP-CHECK Study. Am J Hypertens. 2024 Oct 14;37(11):868-875. doi: 10.1093/ajh/hpae088.

  PMID: 38995194 DERIVED

• Hall YN, Anderson ML, McClure JB, Ehrlich K, Hansell LD, Hsu CW, Margolis KL, Munson SA, Thompson MJ, Green BB. Relationship of Blood Pressure, Health Behaviors, and New Diagnosis and Control of Hypertension in the BP-CHECK Study. Circ Cardiovasc Qual Outcomes. 2024 Feb;17(2):e010119. doi: 10.1161/CIRCOUTCOMES.123.010119. Epub 2024 Feb 8.

  PMID: 38328915 DERIVED

• Green BB, Anderson ML, McClure JB, Ehrlich K, Hall YN, Hansell L, Hsu C, Margolis KL, Munson SA, Thompson MJ. Is Hypertension Diagnostic Testing and Diagnosis Associated With Psychological Distress? Am J Hypertens. 2024 Jan 1;37(1):69-76. doi: 10.1093/ajh/hpad083.

  PMID: 37688515 DERIVED

• Hsu C, Hansell L, Ehrlich K, Munson S, Anderson M, Margolis KL, McClure JB, Hall YN, Thompson M, Joseph D, Green BB. Primary care physician beliefs and practices regarding blood pressure measurement: results from BP-CHECK qualitative interviews. BMC Prim Care. 2023 Jan 25;24(1):30. doi: 10.1186/s12875-022-01950-1.

  PMID: 36698062 DERIVED

• Thompson MJ, Anderson ML, Cook AJ, Ehrlich K, Hall YN, Hsu C, Margolis KL, McClure JB, Munson SA, Green BB. Acceptability and Adherence to Home, Kiosk, and Clinic Blood Pressure Measurement Compared to 24-H Ambulatory Monitoring. J Gen Intern Med. 2023 Jun;38(8):1854-1861. doi: 10.1007/s11606-023-08036-3. Epub 2023 Jan 17.

  PMID: 36650328 DERIVED

• Green BB, Anderson ML, Cook AJ, Ehrlich K, Hall YN, Hsu C, Joseph D, Klasnja P, Margolis KL, McClure JB, Munson SA, Thompson MJ. Clinic, Home, and Kiosk Blood Pressure Measurements for Diagnosing Hypertension: a Randomized Diagnostic Study. J Gen Intern Med. 2022 Sep;37(12):2948-2956. doi: 10.1007/s11606-022-07400-z. Epub 2022 Mar 3.

  PMID: 35239109 DERIVED

• Green BB, Anderson ML, Campbell J, Cook AJ, Ehrlich K, Evers S, Hall YN, Hsu C, Joseph D, Klasnja P, Margolis KL, McClure JB, Munson SA, Thompson MJ. Blood pressure checks and diagnosing hypertension (BP-CHECK): Design and methods of a randomized controlled diagnostic study comparing clinic, home, kiosk, and 24-hour ambulatory BP monitoring. Contemp Clin Trials. 2019 Apr;79:1-13. doi: 10.1016/j.cct.2019.01.003. Epub 2019 Jan 8.

  PMID: 30634036 DERIVED

MeSH Terms

Interventions

Blood Pressure Monitoring, Ambulatory

Intervention Hierarchy (Ancestors)

Blood Pressure Determination; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Monitoring, Ambulatory; Monitoring, Physiologic

Limitations and Caveats

Participants had to have high blood pressure (BP) to be eligible, thus our results may not be generalizable to a population with lower BPs. Diverse groups were somewhat under-represented, but reflective of the underlying demographics of the region.

Results Point of Contact

• Title: Beverly B. Green, MD, MPH
• Organization: Kaiser Permanente Washington Health Research Institute

Bev.B.Green@kp.org

206-287-2997

Study Officials

• Beverly B Green, MD, MPH

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2017
• First Posted: April 26, 2017
• Study Start: May 11, 2017
• Primary Completion: August 26, 2019
• Study Completion: August 26, 2019
• Last Updated: November 16, 2020
• Results First Posted: November 16, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)