Trial Outcomes & Findings for The PCORnet Blood Pressure Home Monitoring Study (NCT NCT03796689)
NCT ID: NCT03796689
Last Updated: 2022-11-16
Results Overview
Change is defined by the absolute difference between the SBP measured at the most recent outpatient clinical encounter at the time of enrollment, and the SBP measured at the most recent outpatient clinical encounter 6 months after enrollment. If more than 1 measurement is recorded during a single clinical encounter, the lower/lowest will be used.
COMPLETED
NA
2238 participants
Baseline and 6 months
2022-11-16
Participant Flow
Patients meeting screening criteria were invited to participate by mail, email, phone, patient portal message or in person, and directed to the online study portal for eligibility assessment. The first participant was enrolled on August 15, 2019 and the last participant was enrolled on December 31, 2020.
137 participants who withdrew consent prior to randomization or did not complete their baseline surveys were excluded.
Participant milestones
| Measure |
Smartphone-linked
Smartphone-linked HBPM and associated app: Participants in the Smartphone-linked arm of the study will receive an Omron 786N Home Blood Pressure Monitor (HBPM) that can be linked to the Omron Connect app via Bluetooth. They will also receive instructions about how to use their device and download the app and will be provided with publicly available guidelines for HBPM. Participants will be instructed to use their device and app to take readings which they can track over time and share with their provider using the app.
|
Standard
Standard HBPM: Participants in the Standard arm of the study will receive an Omron 785N Home Blood Pressure Monitor (HBPM), instructions about how to use their device and publicly available guidelines for HBPM. They will be instructed to use their device to take readings which they can track over time and share with their provider.
|
|---|---|---|
|
Overall Study
STARTED
|
1051
|
1050
|
|
Overall Study
COMPLETED
|
1051
|
1050
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The PCORnet Blood Pressure Home Monitoring Study
Baseline characteristics by cohort
| Measure |
Smartphone-linked
n=1051 Participants
Smartphone-linked HBPM and associated app: Participants in the Smartphone-linked arm of the study will receive an Omron 786N Home Blood Pressure Monitor (HBPM) that can be linked to the Omron Connect app via Bluetooth. They will also receive instructions about how to use their device and download the app and will be provided with publicly available guidelines for HBPM. Participants will be instructed to use their device and app to take readings which they can track over time and share with their provider using the app.
|
Standard
n=1050 Participants
Standard HBPM: Participants in the Standard arm of the study will receive an Omron 785N Home Blood Pressure Monitor (HBPM), instructions about how to use their device and publicly available guidelines for HBPM. They will be instructed to use their device to take readings which they can track over time and share with their provider.
|
Total
n=2101 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 13 • n=99 Participants
|
58 years
STANDARD_DEVIATION 13 • n=107 Participants
|
58 years
STANDARD_DEVIATION 13 • n=206 Participants
|
|
Sex/Gender, Customized
Sex, male
|
462 Participants
n=99 Participants
|
448 Participants
n=107 Participants
|
910 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Sex, female
|
589 Participants
n=99 Participants
|
602 Participants
n=107 Participants
|
1191 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Non-Hispanic Asian
|
6 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Non-Hispanic Black
|
239 Participants
n=99 Participants
|
226 Participants
n=107 Participants
|
465 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Non-Hispanic White
|
676 Participants
n=99 Participants
|
666 Participants
n=107 Participants
|
1342 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic/LatinX, any race
|
79 Participants
n=99 Participants
|
101 Participants
n=107 Participants
|
180 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Non-Hispanic, other/multiple races
|
51 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
86 Participants
n=206 Participants
|
|
Subjective Social Status
|
6.2 units on a scale
STANDARD_DEVIATION 2.2 • n=99 Participants
|
6.2 units on a scale
STANDARD_DEVIATION 2.2 • n=107 Participants
|
6.2 units on a scale
STANDARD_DEVIATION 2.2 • n=206 Participants
|
|
Eligibility systolic BP
|
157 mmHg
STANDARD_DEVIATION 11 • n=99 Participants
|
158 mmHg
STANDARD_DEVIATION 12 • n=107 Participants
|
157 mmHg
STANDARD_DEVIATION 11 • n=206 Participants
|
|
Eligibility diastolic BP
|
88 mmHg
STANDARD_DEVIATION 11 • n=99 Participants
|
88 mmHg
STANDARD_DEVIATION 12 • n=107 Participants
|
88 mmHg
STANDARD_DEVIATION 12 • n=206 Participants
|
|
Satisfaction with BP management
Overall
|
3.8 units on a scale
STANDARD_DEVIATION 1.1 • n=99 Participants
|
3.7 units on a scale
STANDARD_DEVIATION 1.2 • n=107 Participants
|
3.8 units on a scale
STANDARD_DEVIATION 1.2 • n=206 Participants
|
|
Satisfaction with BP management
Your healthcare provider
|
4.3 units on a scale
STANDARD_DEVIATION 1.1 • n=99 Participants
|
4.3 units on a scale
STANDARD_DEVIATION 1.0 • n=107 Participants
|
4.3 units on a scale
STANDARD_DEVIATION 1.0 • n=206 Participants
|
|
Satisfaction with BP management
Your BP medications
|
3.7 units on a scale
STANDARD_DEVIATION 1.2 • n=99 Participants
|
3.7 units on a scale
STANDARD_DEVIATION 1.2 • n=107 Participants
|
3.7 units on a scale
STANDARD_DEVIATION 1.2 • n=206 Participants
|
|
Comfort using technology like a computer or smartphone
|
4.1 units on a scale
STANDARD_DEVIATION 1.1 • n=99 Participants
|
4.1 units on a scale
STANDARD_DEVIATION 1.1 • n=107 Participants
|
4.1 units on a scale
STANDARD_DEVIATION 1.1 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsChange is defined by the absolute difference between the SBP measured at the most recent outpatient clinical encounter at the time of enrollment, and the SBP measured at the most recent outpatient clinical encounter 6 months after enrollment. If more than 1 measurement is recorded during a single clinical encounter, the lower/lowest will be used.
Outcome measures
| Measure |
Smartphone-linked
n=1051 Participants
Smartphone-linked HBPM and associated app: Participants in the Smartphone-linked arm of the study will receive an Omron 786N Home Blood Pressure Monitor (HBPM) that can be linked to the Omron Connect app via Bluetooth. They will also receive instructions about how to use their device and download the app and will be provided with publicly available guidelines for HBPM. Participants will be instructed to use their device and app to take readings which they can track over time and share with their provider using the app.
|
Standard
n=1050 Participants
Standard HBPM: Participants in the Standard arm of the study will receive an Omron 785N Home Blood Pressure Monitor (HBPM), instructions about how to use their device and publicly available guidelines for HBPM. They will be instructed to use their device to take readings which they can track over time and share with their provider.
|
|---|---|---|
|
Change in Systolic Blood Pressure (SBP)
|
10.8 mmHg
Standard Deviation 18
|
10.6 mmHg
Standard Deviation 18
|
PRIMARY outcome
Timeframe: 6 monthsThis score is assessed by asking a single question about likelihood of recommending the device to a friend, with options from 1-10 (10 being extremely likely). As per published methods, persons indicating 9 or 10 are considered "Promoters"; persons indicating 7 or 8 are "Passives"; and persons indicating 1-6 are "Detractors". The score is calculated by taking the percent of Promoters and subtracting the percent of Detractors, yielding a score for each group ranging from -100 to 100, with higher scores indicating a better outcome.
Outcome measures
| Measure |
Smartphone-linked
n=1051 Participants
Smartphone-linked HBPM and associated app: Participants in the Smartphone-linked arm of the study will receive an Omron 786N Home Blood Pressure Monitor (HBPM) that can be linked to the Omron Connect app via Bluetooth. They will also receive instructions about how to use their device and download the app and will be provided with publicly available guidelines for HBPM. Participants will be instructed to use their device and app to take readings which they can track over time and share with their provider using the app.
|
Standard
n=1050 Participants
Standard HBPM: Participants in the Standard arm of the study will receive an Omron 785N Home Blood Pressure Monitor (HBPM), instructions about how to use their device and publicly available guidelines for HBPM. They will be instructed to use their device to take readings which they can track over time and share with their provider.
|
|---|---|---|
|
Net Promoter Score
|
59 score on a scale
Standard Deviation 2.81
|
57 score on a scale
Standard Deviation 4.00
|
Adverse Events
Smartphone-linked
Standard
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Mark Pletcher, Professor
University of California, San Fransico
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place