Blood PressureNCT03130257
Blood Pressure Checks for Diagnosing Hypertension (BP-CHECK)
A study testing Clinic Blood Pressure Measurement, Home Blood Pressure Measurement and Kiosk Blood Pressure Measurement in people with Blood Pressure, run by Kaiser Permanente at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Clinic Blood Pressure Measurement, Home Blood Pressure Measurement and Kiosk Blood Pressure Measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 510 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2017to 26 Aug 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- children and pregnant women,
- patients with end-stage renal disease,
- dementia,
- atrial fibrillation and other significant arrhythmias.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Washington
Seattle, Washington, 98023
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Blood Pressure
- Being tested
- Clinic Blood Pressure Measurement, Home Blood Pressure Measurement, Kiosk Blood Pressure Measurement, 24-hour Ambulatory Blood Pressure Monitoring (Reference Standard)
- Keywords
- blood pressure measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinic Blood Pressure MeasurementDiagnostic test
Participants will be asked to check their blood pressure once within the subsequent three weeks.
Home Blood Pressure MeasurementDiagnostic 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.
Kiosk Blood Pressure MeasurementDiagnostic 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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Clinic Blood Pressure Measurement | Active comparator | Participants will be asked to check their blood pressure at their clinic once within the subsequent three weeks. Receives: 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. Receives: 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. Receives: Diagnostic Test: Kiosk Blood Pressure Measurement; Diagnostic Test: 24-hour Ambulatory Blood Pressure Monitoring (Reference Standard) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Randomization to three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start11 May 2017
- Primary completion26 Aug 2019
- Study completion26 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 510 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Beverly B Green, MD, MPH, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03130257
- Sponsor's protocol ID
- CER-1511-32979
- Status last verified
- Oct 2020
- First submitted
- 21 Apr 2017
- Last updated
- 16 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 38995194Hall 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.
PubMed 38328915Green 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.
PubMed 37688515Hsu 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.
PubMed 36698062Thompson 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.
PubMed 36650328Green 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.
PubMed 35239109Green 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.
PubMed 30634036
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Pressure Checks for Diagnosing Hypertension (BP-CHECK)
- ClinicalTrials.gov ID
- NCT03130257
- Acronym / sponsor ID
- CER-1511-32979
- Conditions
- Blood Pressure
- Keywords
- blood pressure measurement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 510 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 11 May 2017 (actual)
- Primary completion
- 26 Aug 2019 (actual)
- Study completion
- 26 Aug 2019 (actual)
- First posted
- 26 Apr 2017 (actual)
- Results
- Posted 16 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clinic Blood Pressure Measurement | Active comparator | Diagnostic Test: Clinic Blood Pressure Measurement, Diagnostic Test: 24-hour Ambulatory Blood Pressure Monitoring (Reference Standard)Participants will be asked to check their blood pressure at their clinic once within the subsequent three weeks. |
| Home Blood Pressure Measurement | Active comparator | Diagnostic Test: Home Blood Pressure Measurement, Diagnostic Test: 24-hour Ambulatory Blood Pressure Monitoring (Reference Standard)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. |
| Kiosk Blood Pressure Measurement | Active comparator | Diagnostic Test: Kiosk Blood Pressure Measurement, Diagnostic Test: 24-hour Ambulatory Blood Pressure Monitoring (Reference Standard)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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (4 listed)
- children and pregnant women,
- patients with end-stage renal disease,
- dementia,
- atrial fibrillation and other significant arrhythmias.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinic Blood Pressure MeasurementParticipants will be asked to check their blood pressure once within the subsequent three weeks. | Diagnostic test | Clinic Blood Pressure Measurement |
| Home Blood Pressure MeasurementParticipants 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 | Home Blood Pressure Measurement |
| Kiosk Blood Pressure MeasurementParticipants 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 |
| 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. | Diagnostic test | Clinic Blood Pressure Measurement, Home Blood Pressure Measurement, Kiosk Blood Pressure Measurement |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38995194Hansell 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.
- Derived from this study: PubMed 38328915Hall 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.
- Derived from this study: PubMed 37688515Green 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.
- Derived from this study: PubMed 36698062Hsu 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.
- Derived from this study: PubMed 36650328Thompson 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.
- Derived from this study: PubMed 35239109Green 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.
- Derived from this study: PubMed 30634036Green 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.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Blood Pressure
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
RecruitingPhase 3
A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
Chronic Kidney Disease and Hypertension
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingPhase 4
Hematological Safety of Dipyrone Versus Paracetamol After Dental Extractions
Hematologic Test, Agranulocytosis
Not yet recruiting
Acute Effects of Mat Pilates on Blood Pressure Response to Mental Stress in Higher Education Teachers
Behavior
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beverly B Green, MD, MPH principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinic Blood Pressure Measurement, Home Blood Pressure Measurement and Kiosk Blood Pressure Measurement in people with Blood Pressure, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparative Performance of Clinic, Home, and Kiosk (time frame: Randomization to three weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03130257, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2020.