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NCT03130257 · ClinicalTrials.gov registry record · NA
Blood Pressure Checks for Diagnosing Hypertension (BP-CHECK)
A NA study, sponsored by Kaiser Permanente.
- Completed
- Registry status
- NA
- Development phase
- 510
- Enrollment target
NCT03130257 is a NA study that has completed, run by Kaiser Permanente. The registered enrollment target is 510 participants.
The verdict
NCT03130257, a NA study, has completed, sponsored by Kaiser Permanente.
- COMPLETED
- Registry status
- NA
- Development phase
- 510 participants
- Enrollment target
Study 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
Interventions
- 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)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 510 participants |
| Start Date | 2017-05-11 |
| Est. Completion | 2019-08-26 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03130257
The ClinicalTrials.gov registry entry for NCT03130257 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 510 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kaiser Permanente, which has 294 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Clinic Blood Pressure Measurement is the first listed.
NCT03130257 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03130257 about?
NCT03130257 is a clinical study titled "Blood Pressure Checks for Diagnosing Hypertension (BP-CHECK)". 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...
What is the current status of trial NCT03130257?
This trial is currently completed. It is a NA study. The enrollment target is 510 participants. The study started on 2017-05-11. Estimated completion is 2019-08-26.
What interventions are being tested in trial NCT03130257?
The interventions under investigation include: 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).
Who is sponsoring clinical trial NCT03130257?
This trial is sponsored by Kaiser Permanente, which has 294 total clinical trials registered on ClinicalTrials.gov.
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