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N/A N=510 Randomized Screening

Blood Pressure Checks for Diagnosing Hypertension (BP-CHECK)

Blood Pressure

Enrolled (actual)
510
Serious AEs
2.0%
Results posted
Nov 2020
Primary outcome: Primary: Comparative Performance of Clinic, Home, and Kiosk — -4.7; -0.1; 9.5; -7.2 millimeters of mercury — p=<0.05

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
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) (Diagnostic_test)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Kaiser Permanente
Primary completion
Aug 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Comparative Performance of Clinic, Home, and Kiosk
-4.7; -0.1; 9.5; -7.2; -0.4; 5.0 <0.05 sig

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.

Eligibility 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03130257). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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