Trial Outcomes & Findings for Blood Pressure Checks for Diagnosing Hypertension (BP-CHECK) (NCT NCT03130257)

Last Updated: 2020-11-16

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

510 participants

Primary outcome timeframe

Randomization to three weeks

Results posted on

2020-11-16

Participant Flow

Participant milestones

Participant milestones
Measure	Clinic Blood Pressure Measurement Participants will be asked to check their blood pressure at their clinic once within the subsequent 3 weeks. Blood Pressure Measurement: We are comparing 3 types of measuring blood pressure for making a new diagnosis of hypertension, clinic blood pressure, home blood pressure, and kiosk blood pressure measurements over a 3 week diagnostic time period	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 3 weeks. Blood Pressure Measurement: We are comparing 3 types of measuring blood pressure for making a new diagnosis of hypertension, clinic blood pressure, home blood pressure, and kiosk blood pressure measurements over a 3 week diagnostic time period	Kiosk Blood Pressure Measurement Participants will be asked to use a validated blood pressure kiosk in their clinic or local pharmacy. Blood Pressure Measurement: We are comparing 3 types of measuring blood pressure for making a new diagnosis of hypertension, clinic blood pressure, home blood pressure, and kiosk blood pressure measurements over a 3 week diagnostic time period
Overall Study STARTED	172	170	168
Overall Study COMPLETED	171	170	166
Overall Study NOT COMPLETED	1	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Clinic Blood Pressure Measurement Participants will be asked to check their blood pressure at their clinic once within the subsequent 3 weeks. Blood Pressure Measurement: We are comparing 3 types of measuring blood pressure for making a new diagnosis of hypertension, clinic blood pressure, home blood pressure, and kiosk blood pressure measurements over a 3 week diagnostic time period	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 3 weeks. Blood Pressure Measurement: We are comparing 3 types of measuring blood pressure for making a new diagnosis of hypertension, clinic blood pressure, home blood pressure, and kiosk blood pressure measurements over a 3 week diagnostic time period	Kiosk Blood Pressure Measurement Participants will be asked to use a validated blood pressure kiosk in their clinic or local pharmacy. Blood Pressure Measurement: We are comparing 3 types of measuring blood pressure for making a new diagnosis of hypertension, clinic blood pressure, home blood pressure, and kiosk blood pressure measurements over a 3 week diagnostic time period
Overall Study Withdrawal by Subject	1	0	2

Baseline Characteristics

Blood Pressure Checks for Diagnosing Hypertension (BP-CHECK)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clinic Blood Pressure Measurement n=172 Participants Participants will be asked to check their blood pressure at their clinic once within the subsequent 3 weeks. Blood Pressure Measurement: We are comparing 3 types of measuring blood pressure for making a new diagnosis of hypertension, clinic blood pressure, home blood pressure, and kiosk blood pressure measurements over a 3 week diagnostic time period	Home Blood Pressure Measurement n=170 Participants 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 3 weeks. Blood Pressure Measurement: We are comparing 3 types of measuring blood pressure for making a new diagnosis of hypertension, clinic blood pressure, home blood pressure, and kiosk blood pressure measurements over a 3 week diagnostic time period	Kiosk Blood Pressure Measurement n=168 Participants Participants will be asked to use a validated blood pressure kiosk in their clinic or local pharmacy. Blood Pressure Measurement: We are comparing 3 types of measuring blood pressure for making a new diagnosis of hypertension, clinic blood pressure, home blood pressure, and kiosk blood pressure measurements over a 3 week diagnostic time period	Total n=510 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	103 Participants n=5 Participants	99 Participants n=7 Participants	102 Participants n=5 Participants	304 Participants n=4 Participants
Age, Categorical >=65 years	69 Participants n=5 Participants	71 Participants n=7 Participants	66 Participants n=5 Participants	206 Participants n=4 Participants
Age, Continuous	58.1 years STANDARD_DEVIATION 14.2 • n=5 Participants	59.3 years STANDARD_DEVIATION 13.2 • n=7 Participants	58.9 years STANDARD_DEVIATION 12.9 • n=5 Participants	58.8 years STANDARD_DEVIATION 13.4 • n=4 Participants
Sex: Female, Male Female	82 Participants n=5 Participants	86 Participants n=7 Participants	79 Participants n=5 Participants	247 Participants n=4 Participants
Sex: Female, Male Male	90 Participants n=5 Participants	84 Participants n=7 Participants	89 Participants n=5 Participants	263 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants	19 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	160 Participants n=5 Participants	165 Participants n=7 Participants	157 Participants n=5 Participants	482 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	9 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Asian	9 Participants n=5 Participants	10 Participants n=7 Participants	9 Participants n=5 Participants	28 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants	13 Participants n=7 Participants	8 Participants n=5 Participants	34 Participants n=4 Participants
Race (NIH/OMB) White	136 Participants n=5 Participants	137 Participants n=7 Participants	136 Participants n=5 Participants	409 Participants n=4 Participants
Race (NIH/OMB) More than one race	6 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	16 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants	18 Participants n=4 Participants
Region of Enrollment United States	172 participants n=5 Participants	170 participants n=7 Participants	168 participants n=5 Participants	510 participants n=4 Participants
Baseline systolic blood pressure	149.4 millimeters of mercury STANDARD_DEVIATION 9.8 • n=5 Participants	149.9 millimeters of mercury STANDARD_DEVIATION 11.0 • n=7 Participants	150.1 millimeters of mercury STANDARD_DEVIATION 9.4 • n=5 Participants	149.8 millimeters of mercury STANDARD_DEVIATION 10.1 • n=4 Participants
Baseline diastolic blood pressure	88.5 millimeters of mercury STANDARD_DEVIATION 9.3 • n=5 Participants	87.9 millimeters of mercury STANDARD_DEVIATION 9.2 • n=7 Participants	88.0 millimeters of mercury STANDARD_DEVIATION 9.6 • n=5 Participants	88.1 millimeters of mercury STANDARD_DEVIATION 9.3 • n=4 Participants

PRIMARY outcome

Timeframe: Randomization to three weeks

Population: The primary analysis population included all participants who completed 14 or more daytime 24-hour BP measurements, plus one or more measurements according to their randomization group.

Outcome measures

Outcome measures
Measure	Clinic Blood Pressure Measurement n=142 Participants Participants will be asked to check their blood pressure at their clinic once within the subsequent 3 weeks. Blood Pressure Measurement: We are comparing 3 types of measuring blood pressure for making a new diagnosis of hypertension, clinic blood pressure, home blood pressure, and kiosk blood pressure measurements over a 3 week diagnostic time period	Home Blood Pressure Measurement n=152 Participants 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 3 weeks. Blood Pressure Measurement: We are comparing 3 types of measuring blood pressure for making a new diagnosis of hypertension, clinic blood pressure, home blood pressure, and kiosk blood pressure measurements over a 3 week diagnostic time period	Kiosk Blood Pressure Measurement n=140 Participants Participants will be asked to use a validated blood pressure kiosk in their clinic or local pharmacy. Blood Pressure Measurement: We are comparing 3 types of measuring blood pressure for making a new diagnosis of hypertension, clinic blood pressure, home blood pressure, and kiosk blood pressure measurements over a 3 week diagnostic time period
Comparative Performance of Clinic, Home, and Kiosk Systolic BP Mean difference diagnostic vs 24-hour	-4.7 millimeters of mercury Interval -7.3 to -2.2	-0.1 millimeters of mercury Interval -1.6 to 1.5	9.5 millimeters of mercury Interval 7.5 to 11.6
Comparative Performance of Clinic, Home, and Kiosk Diastolic BP Mean difference diagnostic vs 24-hour	-7.2 millimeters of mercury Interval -8.8 to -5.5	-0.4 millimeters of mercury Interval -1.4 to 0.7	5.0 millimeters of mercury Interval 3.8 to 6.2

Adverse Events

Clinic Blood Pressure Measurement

Serious events: 5 serious events

Other events: 38 other events

Deaths: 0 deaths

Home Blood Pressure Measurement

Serious events: 2 serious events

Other events: 38 other events

Deaths: 0 deaths

Kiosk Blood Pressure Measurement

Serious events: 3 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Clinic Blood Pressure Measurement n=172 participants at risk Participants will be asked to check their blood pressure at their clinic once within the subsequent 3 weeks. Blood Pressure Measurement: We are comparing 3 types of measuring blood pressure for making a new diagnosis of hypertension, clinic blood pressure, home blood pressure, and kiosk blood pressure measurements over a 3 week diagnostic time period	Home Blood Pressure Measurement n=170 participants at risk 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 3 weeks. Blood Pressure Measurement: We are comparing 3 types of measuring blood pressure for making a new diagnosis of hypertension, clinic blood pressure, home blood pressure, and kiosk blood pressure measurements over a 3 week diagnostic time period	Kiosk Blood Pressure Measurement n=168 participants at risk Participants will be asked to use a validated blood pressure kiosk in their clinic or local pharmacy. Blood Pressure Measurement: We are comparing 3 types of measuring blood pressure for making a new diagnosis of hypertension, clinic blood pressure, home blood pressure, and kiosk blood pressure measurements over a 3 week diagnostic time period
Surgical and medical procedures Hospitalization: Back operation	0.58% 1/172 • Number of events 1 • Self-reported adverse events were collected post-randomization via survey at: 1) 3 weeks; 2) 3 weeks and one day (after collection of 24-hour BP monitor data); and 3) 6-months. The definitions of adverse event or serious adverse event do not differ from ClinicalTrials.gov definitions. Adverse events were collected using an open text self-report question "Since you enrolled in this study, about \[x-time\] ago, have you experienced any new and serious health problems?" All responses were collated and coded.	0.00% 0/170 • Self-reported adverse events were collected post-randomization via survey at: 1) 3 weeks; 2) 3 weeks and one day (after collection of 24-hour BP monitor data); and 3) 6-months. The definitions of adverse event or serious adverse event do not differ from ClinicalTrials.gov definitions. Adverse events were collected using an open text self-report question "Since you enrolled in this study, about \[x-time\] ago, have you experienced any new and serious health problems?" All responses were collated and coded.	0.00% 0/168 • Self-reported adverse events were collected post-randomization via survey at: 1) 3 weeks; 2) 3 weeks and one day (after collection of 24-hour BP monitor data); and 3) 6-months. The definitions of adverse event or serious adverse event do not differ from ClinicalTrials.gov definitions. Adverse events were collected using an open text self-report question "Since you enrolled in this study, about \[x-time\] ago, have you experienced any new and serious health problems?" All responses were collated and coded.
Surgical and medical procedures Hospitalization: Surgery for enlarged prostate & bladder stones	0.58% 1/172 • Number of events 1 • Self-reported adverse events were collected post-randomization via survey at: 1) 3 weeks; 2) 3 weeks and one day (after collection of 24-hour BP monitor data); and 3) 6-months. The definitions of adverse event or serious adverse event do not differ from ClinicalTrials.gov definitions. Adverse events were collected using an open text self-report question "Since you enrolled in this study, about \[x-time\] ago, have you experienced any new and serious health problems?" All responses were collated and coded.	0.00% 0/170 • Self-reported adverse events were collected post-randomization via survey at: 1) 3 weeks; 2) 3 weeks and one day (after collection of 24-hour BP monitor data); and 3) 6-months. The definitions of adverse event or serious adverse event do not differ from ClinicalTrials.gov definitions. Adverse events were collected using an open text self-report question "Since you enrolled in this study, about \[x-time\] ago, have you experienced any new and serious health problems?" All responses were collated and coded.	0.00% 0/168 • Self-reported adverse events were collected post-randomization via survey at: 1) 3 weeks; 2) 3 weeks and one day (after collection of 24-hour BP monitor data); and 3) 6-months. The definitions of adverse event or serious adverse event do not differ from ClinicalTrials.gov definitions. Adverse events were collected using an open text self-report question "Since you enrolled in this study, about \[x-time\] ago, have you experienced any new and serious health problems?" All responses were collated and coded.
Surgical and medical procedures Hospitalization: Surgery for removal appendix, bowel resection	0.58% 1/172 • Number of events 1 • Self-reported adverse events were collected post-randomization via survey at: 1) 3 weeks; 2) 3 weeks and one day (after collection of 24-hour BP monitor data); and 3) 6-months. The definitions of adverse event or serious adverse event do not differ from ClinicalTrials.gov definitions. Adverse events were collected using an open text self-report question "Since you enrolled in this study, about \[x-time\] ago, have you experienced any new and serious health problems?" All responses were collated and coded.	0.00% 0/170 • Self-reported adverse events were collected post-randomization via survey at: 1) 3 weeks; 2) 3 weeks and one day (after collection of 24-hour BP monitor data); and 3) 6-months. The definitions of adverse event or serious adverse event do not differ from ClinicalTrials.gov definitions. Adverse events were collected using an open text self-report question "Since you enrolled in this study, about \[x-time\] ago, have you experienced any new and serious health problems?" All responses were collated and coded.	0.00% 0/168 • Self-reported adverse events were collected post-randomization via survey at: 1) 3 weeks; 2) 3 weeks and one day (after collection of 24-hour BP monitor data); and 3) 6-months. The definitions of adverse event or serious adverse event do not differ from ClinicalTrials.gov definitions. Adverse events were collected using an open text self-report question "Since you enrolled in this study, about \[x-time\] ago, have you experienced any new and serious health problems?" All responses were collated and coded.
Surgical and medical procedures Hospitalization: Bladder surgery	0.58% 1/172 • Number of events 1 • Self-reported adverse events were collected post-randomization via survey at: 1) 3 weeks; 2) 3 weeks and one day (after collection of 24-hour BP monitor data); and 3) 6-months. The definitions of adverse event or serious adverse event do not differ from ClinicalTrials.gov definitions. Adverse events were collected using an open text self-report question "Since you enrolled in this study, about \[x-time\] ago, have you experienced any new and serious health problems?" All responses were collated and coded.	0.00% 0/170 • Self-reported adverse events were collected post-randomization via survey at: 1) 3 weeks; 2) 3 weeks and one day (after collection of 24-hour BP monitor data); and 3) 6-months. The definitions of adverse event or serious adverse event do not differ from ClinicalTrials.gov definitions. Adverse events were collected using an open text self-report question "Since you enrolled in this study, about \[x-time\] ago, have you experienced any new and serious health problems?" All responses were collated and coded.	0.00% 0/168 • Self-reported adverse events were collected post-randomization via survey at: 1) 3 weeks; 2) 3 weeks and one day (after collection of 24-hour BP monitor data); and 3) 6-months. The definitions of adverse event or serious adverse event do not differ from ClinicalTrials.gov definitions. Adverse events were collected using an open text self-report question "Since you enrolled in this study, about \[x-time\] ago, have you experienced any new and serious health problems?" All responses were collated and coded.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.58% 1/172 • Number of events 1 • Self-reported adverse events were collected post-randomization via survey at: 1) 3 weeks; 2) 3 weeks and one day (after collection of 24-hour BP monitor data); and 3) 6-months. The definitions of adverse event or serious adverse event do not differ from ClinicalTrials.gov definitions. Adverse events were collected using an open text self-report question "Since you enrolled in this study, about \[x-time\] ago, have you experienced any new and serious health problems?" All responses were collated and coded.	0.00% 0/170 • Self-reported adverse events were collected post-randomization via survey at: 1) 3 weeks; 2) 3 weeks and one day (after collection of 24-hour BP monitor data); and 3) 6-months. The definitions of adverse event or serious adverse event do not differ from ClinicalTrials.gov definitions. Adverse events were collected using an open text self-report question "Since you enrolled in this study, about \[x-time\] ago, have you experienced any new and serious health problems?" All responses were collated and coded.	0.00% 0/168 • Self-reported adverse events were collected post-randomization via survey at: 1) 3 weeks; 2) 3 weeks and one day (after collection of 24-hour BP monitor data); and 3) 6-months. The definitions of adverse event or serious adverse event do not differ from ClinicalTrials.gov definitions. Adverse events were collected using an open text self-report question "Since you enrolled in this study, about \[x-time\] ago, have you experienced any new and serious health problems?" All responses were collated and coded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/172 • Self-reported adverse events were collected post-randomization via survey at: 1) 3 weeks; 2) 3 weeks and one day (after collection of 24-hour BP monitor data); and 3) 6-months. The definitions of adverse event or serious adverse event do not differ from ClinicalTrials.gov definitions. Adverse events were collected using an open text self-report question "Since you enrolled in this study, about \[x-time\] ago, have you experienced any new and serious health problems?" All responses were collated and coded.	0.59% 1/170 • Number of events 1 • Self-reported adverse events were collected post-randomization via survey at: 1) 3 weeks; 2) 3 weeks and one day (after collection of 24-hour BP monitor data); and 3) 6-months. The definitions of adverse event or serious adverse event do not differ from ClinicalTrials.gov definitions. Adverse events were collected using an open text self-report question "Since you enrolled in this study, about \[x-time\] ago, have you experienced any new and serious health problems?" All responses were collated and coded.	0.00% 0/168 • Self-reported adverse events were collected post-randomization via survey at: 1) 3 weeks; 2) 3 weeks and one day (after collection of 24-hour BP monitor data); and 3) 6-months. The definitions of adverse event or serious adverse event do not differ from ClinicalTrials.gov definitions. Adverse events were collected using an open text self-report question "Since you enrolled in this study, about \[x-time\] ago, have you experienced any new and serious health problems?" All responses were collated and coded.
Surgical and medical procedures Hospitalization: Knee replacement surgery	0.00% 0/172 • Self-reported adverse events were collected post-randomization via survey at: 1) 3 weeks; 2) 3 weeks and one day (after collection of 24-hour BP monitor data); and 3) 6-months. The definitions of adverse event or serious adverse event do not differ from ClinicalTrials.gov definitions. Adverse events were collected using an open text self-report question "Since you enrolled in this study, about \[x-time\] ago, have you experienced any new and serious health problems?" All responses were collated and coded.	0.59% 1/170 • Number of events 1 • Self-reported adverse events were collected post-randomization via survey at: 1) 3 weeks; 2) 3 weeks and one day (after collection of 24-hour BP monitor data); and 3) 6-months. The definitions of adverse event or serious adverse event do not differ from ClinicalTrials.gov definitions. Adverse events were collected using an open text self-report question "Since you enrolled in this study, about \[x-time\] ago, have you experienced any new and serious health problems?" All responses were collated and coded.	0.00% 0/168 • Self-reported adverse events were collected post-randomization via survey at: 1) 3 weeks; 2) 3 weeks and one day (after collection of 24-hour BP monitor data); and 3) 6-months. The definitions of adverse event or serious adverse event do not differ from ClinicalTrials.gov definitions. Adverse events were collected using an open text self-report question "Since you enrolled in this study, about \[x-time\] ago, have you experienced any new and serious health problems?" All responses were collated and coded.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/172 • Self-reported adverse events were collected post-randomization via survey at: 1) 3 weeks; 2) 3 weeks and one day (after collection of 24-hour BP monitor data); and 3) 6-months. The definitions of adverse event or serious adverse event do not differ from ClinicalTrials.gov definitions. Adverse events were collected using an open text self-report question "Since you enrolled in this study, about \[x-time\] ago, have you experienced any new and serious health problems?" All responses were collated and coded.	0.00% 0/170 • Self-reported adverse events were collected post-randomization via survey at: 1) 3 weeks; 2) 3 weeks and one day (after collection of 24-hour BP monitor data); and 3) 6-months. The definitions of adverse event or serious adverse event do not differ from ClinicalTrials.gov definitions. Adverse events were collected using an open text self-report question "Since you enrolled in this study, about \[x-time\] ago, have you experienced any new and serious health problems?" All responses were collated and coded.	0.60% 1/168 • Number of events 1 • Self-reported adverse events were collected post-randomization via survey at: 1) 3 weeks; 2) 3 weeks and one day (after collection of 24-hour BP monitor data); and 3) 6-months. The definitions of adverse event or serious adverse event do not differ from ClinicalTrials.gov definitions. Adverse events were collected using an open text self-report question "Since you enrolled in this study, about \[x-time\] ago, have you experienced any new and serious health problems?" All responses were collated and coded.
Immune system disorders Severe allergic reaction	0.00% 0/172 • Self-reported adverse events were collected post-randomization via survey at: 1) 3 weeks; 2) 3 weeks and one day (after collection of 24-hour BP monitor data); and 3) 6-months. The definitions of adverse event or serious adverse event do not differ from ClinicalTrials.gov definitions. Adverse events were collected using an open text self-report question "Since you enrolled in this study, about \[x-time\] ago, have you experienced any new and serious health problems?" All responses were collated and coded.	0.00% 0/170 • Self-reported adverse events were collected post-randomization via survey at: 1) 3 weeks; 2) 3 weeks and one day (after collection of 24-hour BP monitor data); and 3) 6-months. The definitions of adverse event or serious adverse event do not differ from ClinicalTrials.gov definitions. Adverse events were collected using an open text self-report question "Since you enrolled in this study, about \[x-time\] ago, have you experienced any new and serious health problems?" All responses were collated and coded.	0.60% 1/168 • Number of events 1 • Self-reported adverse events were collected post-randomization via survey at: 1) 3 weeks; 2) 3 weeks and one day (after collection of 24-hour BP monitor data); and 3) 6-months. The definitions of adverse event or serious adverse event do not differ from ClinicalTrials.gov definitions. Adverse events were collected using an open text self-report question "Since you enrolled in this study, about \[x-time\] ago, have you experienced any new and serious health problems?" All responses were collated and coded.
Surgical and medical procedures Hospitalization: Surgery to implant stents	0.00% 0/172 • Self-reported adverse events were collected post-randomization via survey at: 1) 3 weeks; 2) 3 weeks and one day (after collection of 24-hour BP monitor data); and 3) 6-months. The definitions of adverse event or serious adverse event do not differ from ClinicalTrials.gov definitions. Adverse events were collected using an open text self-report question "Since you enrolled in this study, about \[x-time\] ago, have you experienced any new and serious health problems?" All responses were collated and coded.	0.00% 0/170 • Self-reported adverse events were collected post-randomization via survey at: 1) 3 weeks; 2) 3 weeks and one day (after collection of 24-hour BP monitor data); and 3) 6-months. The definitions of adverse event or serious adverse event do not differ from ClinicalTrials.gov definitions. Adverse events were collected using an open text self-report question "Since you enrolled in this study, about \[x-time\] ago, have you experienced any new and serious health problems?" All responses were collated and coded.	0.60% 1/168 • Number of events 1 • Self-reported adverse events were collected post-randomization via survey at: 1) 3 weeks; 2) 3 weeks and one day (after collection of 24-hour BP monitor data); and 3) 6-months. The definitions of adverse event or serious adverse event do not differ from ClinicalTrials.gov definitions. Adverse events were collected using an open text self-report question "Since you enrolled in this study, about \[x-time\] ago, have you experienced any new and serious health problems?" All responses were collated and coded.

Other adverse events

Additional Information

Beverly B. Green, MD, MPH

Kaiser Permanente Washington Health Research Institute

Phone: 206-287-2997

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place