Trial Outcomes & Findings for The Smart Hypertension Control Study (NCT NCT03288142)
NCT ID: NCT03288142
Last Updated: 2022-04-15
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
333 participants
Primary outcome timeframe
6 months
Results posted on
2022-04-15
Participant Flow
Participant milestones
| Measure |
Hypertension Coaching Application and Home Monitor
The intervention group will receive all the interventions provided to the control group. In addition, intervention group participants will install on their mobile phone the hypertension personal control program (HPCP) ("Lark HTN Pro"), which is a smartphone application. The intervention group will have the HPCP installed on their iOS device during their initial office visit (screening/baseline) and will successfully take a reading from their HBMD. The HPCP has blood pressure, medication, and weight monitoring, including periodic reminders for the user to measure blood pressure, measure weight, and take their medication(s). The HPCP provides real-time feedback based on user input, such as out-of-range measurements and has additional features designed to encourage behavior change in areas such as dietary intake, physical activity, sleep, and stress reduction. Users can set goals and receive guidance and feedback through the app.
|
Tracking Application and Home Monitor
Control group participants will be provided with a home blood pressure monitoring device (HBMD) (Omron BP761N Bluetooth Smart Automatic Upper Arm Blood Pressure Monitor) and will be instructed in its use at the baseline study visit. Participants will also receive an information sheet describing home blood pressure monitoring that gives advice for how to respond to different home readings. At the baseline visit, participants will be instructed to install an Omron application to their smart phone device (to monitor use of the HBMD). Participants will continue to receive all routine care, including anti-hypertensive medications as prescribed by their regular clinicians.
|
|---|---|---|
|
Overall Study
STARTED
|
166
|
167
|
|
Overall Study
COMPLETED
|
144
|
152
|
|
Overall Study
NOT COMPLETED
|
22
|
15
|
Reasons for withdrawal
| Measure |
Hypertension Coaching Application and Home Monitor
The intervention group will receive all the interventions provided to the control group. In addition, intervention group participants will install on their mobile phone the hypertension personal control program (HPCP) ("Lark HTN Pro"), which is a smartphone application. The intervention group will have the HPCP installed on their iOS device during their initial office visit (screening/baseline) and will successfully take a reading from their HBMD. The HPCP has blood pressure, medication, and weight monitoring, including periodic reminders for the user to measure blood pressure, measure weight, and take their medication(s). The HPCP provides real-time feedback based on user input, such as out-of-range measurements and has additional features designed to encourage behavior change in areas such as dietary intake, physical activity, sleep, and stress reduction. Users can set goals and receive guidance and feedback through the app.
|
Tracking Application and Home Monitor
Control group participants will be provided with a home blood pressure monitoring device (HBMD) (Omron BP761N Bluetooth Smart Automatic Upper Arm Blood Pressure Monitor) and will be instructed in its use at the baseline study visit. Participants will also receive an information sheet describing home blood pressure monitoring that gives advice for how to respond to different home readings. At the baseline visit, participants will be instructed to install an Omron application to their smart phone device (to monitor use of the HBMD). Participants will continue to receive all routine care, including anti-hypertensive medications as prescribed by their regular clinicians.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
22
|
15
|
Baseline Characteristics
22 participants from intervention arm were excluded from analyses for various reasons.14 participants were lost to follow up and were excluded from analyses in the control arm.
Baseline characteristics by cohort
| Measure |
Hypertension Coaching Application and Home Monitor
n=144 Participants
Arm assigned hypertension coaching application and home monitor
|
Tracking Application and Home Monitor
n=152 Participants
Arm assigned tracking application and home monitor
|
Total
n=296 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.6 years
STANDARD_DEVIATION 12.4 • n=99 Participants • 22 participants from intervention arm were excluded from analyses for various reasons.14 participants were lost to follow up and were excluded from analyses in the control arm.
|
58.3 years
STANDARD_DEVIATION 13.2 • n=107 Participants • 22 participants from intervention arm were excluded from analyses for various reasons.14 participants were lost to follow up and were excluded from analyses in the control arm.
|
58.9 years
STANDARD_DEVIATION 12.8 • n=206 Participants • 22 participants from intervention arm were excluded from analyses for various reasons.14 participants were lost to follow up and were excluded from analyses in the control arm.
|
|
Sex: Female, Male
Female
|
91 Participants
n=99 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
91 Participants
n=107 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
182 Participants
n=206 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
|
Sex: Female, Male
Male
|
53 Participants
n=99 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
61 Participants
n=107 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
114 Participants
n=206 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=99 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
13 Participants
n=107 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
23 Participants
n=206 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
134 Participants
n=99 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
139 Participants
n=107 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
273 Participants
n=206 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
0 Participants
n=107 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
0 Participants
n=206 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
0 Participants
n=107 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
0 Participants
n=206 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=99 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
9 Participants
n=107 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
13 Participants
n=206 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
0 Participants
n=107 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
0 Participants
n=206 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
|
Race (NIH/OMB)
Black or African American
|
56 Participants
n=99 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
47 Participants
n=107 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
103 Participants
n=206 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
|
Race (NIH/OMB)
White
|
73 Participants
n=99 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
79 Participants
n=107 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
152 Participants
n=206 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
|
Race (NIH/OMB)
More than one race
|
11 Participants
n=99 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
17 Participants
n=107 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
28 Participants
n=206 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
0 Participants
n=107 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
0 Participants
n=206 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
|
Education
Less thank HS graduate
|
3 Participants
n=99 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
2 Participants
n=107 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
5 Participants
n=206 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
|
Education
Grade 12 or GED
|
10 Participants
n=99 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
16 Participants
n=107 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
26 Participants
n=206 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
|
Education
College 1-3y
|
27 Participants
n=99 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
28 Participants
n=107 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
55 Participants
n=206 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
|
Education
College≥4
|
103 Participants
n=99 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
106 Participants
n=107 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
209 Participants
n=206 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
|
Education
Unknown
|
1 Participants
n=99 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
0 Participants
n=107 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
1 Participants
n=206 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
|
Primary Language
English
|
141 Participants
n=99 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and participants were excluded from analyses in the control arm.
|
143 Participants
n=107 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and participants were excluded from analyses in the control arm.
|
284 Participants
n=206 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and participants were excluded from analyses in the control arm.
|
|
Primary Language
Other
|
3 Participants
n=99 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and participants were excluded from analyses in the control arm.
|
8 Participants
n=107 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and participants were excluded from analyses in the control arm.
|
11 Participants
n=206 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and participants were excluded from analyses in the control arm.
|
|
Primary Language
Refused
|
0 Participants
n=99 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and participants were excluded from analyses in the control arm.
|
1 Participants
n=107 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and participants were excluded from analyses in the control arm.
|
1 Participants
n=206 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and participants were excluded from analyses in the control arm.
|
|
No. of antihypertensive agents used
0
|
34 Participants
n=99 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
53 Participants
n=107 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
87 Participants
n=206 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
|
No. of antihypertensive agents used
1
|
61 Participants
n=99 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
44 Participants
n=107 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
105 Participants
n=206 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
|
No. of antihypertensive agents used
2
|
35 Participants
n=99 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
40 Participants
n=107 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
75 Participants
n=206 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
|
No. of antihypertensive agents used
≥3
|
14 Participants
n=99 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
15 Participants
n=107 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
29 Participants
n=206 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
|
Body mass index
|
31.9 kg/m^2
STANDARD_DEVIATION 8.3 • n=99 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
31.7 kg/m^2
STANDARD_DEVIATION 7.8 • n=107 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
31.8 kg/m^2
STANDARD_DEVIATION 8.0 • n=206 Participants • 22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.
|
PRIMARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Control
n=144 Participants
Control group participants will be provided with a home blood pressure monitoring device (HBMD) (Omron BP761N Bluetooth Smart Automatic Upper Arm Blood Pressure Monitor) and will be instructed in its use at the baseline study visit. Participants will also receive an information sheet describing home blood pressure monitoring that gives advice for how to respond to different home readings. At the baseline visit, participants will be instructed to install an Omron application to their smart phone device (to monitor use of the HBMD). Participants will continue to receive all routine care, including anti-hypertensive medications as prescribed by their regular clinicians.
|
Intervention
n=152 Participants
The intervention group will receive all the interventions provided to the control group. In addition, intervention group participants will install on their mobile phone the hypertension personal control program (HPCP) ("Lark HTN Pro"), which is a smartphone application. The intervention group will have the HPCP installed on their iOS device during their initial office visit (screening/baseline) and will successfully take a reading from their HBMD. The HPCP has blood pressure, medication, and weight monitoring, including periodic reminders for the user to measure blood pressure, measure weight, and take their medication(s). The HPCP provides real-time feedback based on user input, such as out-of-range measurements and has additional features designed to encourage behavior change in areas such as dietary intake, physical activity, sleep, and stress reduction. Users can set goals and receive guidance and feedback through the app.
Lark HTN Pro: The intervention group will have the HPCP
|
|---|---|---|
|
Blood Pressure at 6 Months
Systolic BP
|
135.0 mmHG
Standard Deviation 13.9
|
132.3 mmHG
Standard Deviation 15.0
|
|
Blood Pressure at 6 Months
Diastolic BP
|
85.6 mmHG
Standard Deviation 9.8
|
85.1 mmHG
Standard Deviation 9.6
|
PRIMARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Control
n=144 Participants
Control group participants will be provided with a home blood pressure monitoring device (HBMD) (Omron BP761N Bluetooth Smart Automatic Upper Arm Blood Pressure Monitor) and will be instructed in its use at the baseline study visit. Participants will also receive an information sheet describing home blood pressure monitoring that gives advice for how to respond to different home readings. At the baseline visit, participants will be instructed to install an Omron application to their smart phone device (to monitor use of the HBMD). Participants will continue to receive all routine care, including anti-hypertensive medications as prescribed by their regular clinicians.
|
Intervention
n=152 Participants
The intervention group will receive all the interventions provided to the control group. In addition, intervention group participants will install on their mobile phone the hypertension personal control program (HPCP) ("Lark HTN Pro"), which is a smartphone application. The intervention group will have the HPCP installed on their iOS device during their initial office visit (screening/baseline) and will successfully take a reading from their HBMD. The HPCP has blood pressure, medication, and weight monitoring, including periodic reminders for the user to measure blood pressure, measure weight, and take their medication(s). The HPCP provides real-time feedback based on user input, such as out-of-range measurements and has additional features designed to encourage behavior change in areas such as dietary intake, physical activity, sleep, and stress reduction. Users can set goals and receive guidance and feedback through the app.
Lark HTN Pro: The intervention group will have the HPCP
|
|---|---|---|
|
Blood Pressure <140/90mmHg
|
72 Participants
|
78 Participants
|
SECONDARY outcome
Timeframe: 6 monthsNumber of self reported antihypertensive medication drug classes taken
Outcome measures
| Measure |
Control
n=144 Participants
Control group participants will be provided with a home blood pressure monitoring device (HBMD) (Omron BP761N Bluetooth Smart Automatic Upper Arm Blood Pressure Monitor) and will be instructed in its use at the baseline study visit. Participants will also receive an information sheet describing home blood pressure monitoring that gives advice for how to respond to different home readings. At the baseline visit, participants will be instructed to install an Omron application to their smart phone device (to monitor use of the HBMD). Participants will continue to receive all routine care, including anti-hypertensive medications as prescribed by their regular clinicians.
|
Intervention
n=152 Participants
The intervention group will receive all the interventions provided to the control group. In addition, intervention group participants will install on their mobile phone the hypertension personal control program (HPCP) ("Lark HTN Pro"), which is a smartphone application. The intervention group will have the HPCP installed on their iOS device during their initial office visit (screening/baseline) and will successfully take a reading from their HBMD. The HPCP has blood pressure, medication, and weight monitoring, including periodic reminders for the user to measure blood pressure, measure weight, and take their medication(s). The HPCP provides real-time feedback based on user input, such as out-of-range measurements and has additional features designed to encourage behavior change in areas such as dietary intake, physical activity, sleep, and stress reduction. Users can set goals and receive guidance and feedback through the app.
Lark HTN Pro: The intervention group will have the HPCP
|
|---|---|---|
|
Number of Antihypertensive Agents Used
|
1.3 Antihypertensives
Standard Deviation 1.0
|
1.3 Antihypertensives
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: 6 monthsNumber of antihypertensive drug classes that were increased, added or substituted for another drug class
Outcome measures
| Measure |
Control
n=144 Participants
Control group participants will be provided with a home blood pressure monitoring device (HBMD) (Omron BP761N Bluetooth Smart Automatic Upper Arm Blood Pressure Monitor) and will be instructed in its use at the baseline study visit. Participants will also receive an information sheet describing home blood pressure monitoring that gives advice for how to respond to different home readings. At the baseline visit, participants will be instructed to install an Omron application to their smart phone device (to monitor use of the HBMD). Participants will continue to receive all routine care, including anti-hypertensive medications as prescribed by their regular clinicians.
|
Intervention
n=152 Participants
The intervention group will receive all the interventions provided to the control group. In addition, intervention group participants will install on their mobile phone the hypertension personal control program (HPCP) ("Lark HTN Pro"), which is a smartphone application. The intervention group will have the HPCP installed on their iOS device during their initial office visit (screening/baseline) and will successfully take a reading from their HBMD. The HPCP has blood pressure, medication, and weight monitoring, including periodic reminders for the user to measure blood pressure, measure weight, and take their medication(s). The HPCP provides real-time feedback based on user input, such as out-of-range measurements and has additional features designed to encourage behavior change in areas such as dietary intake, physical activity, sleep, and stress reduction. Users can set goals and receive guidance and feedback through the app.
Lark HTN Pro: The intervention group will have the HPCP
|
|---|---|---|
|
Antihypertensive Medication Intensification, No. of Additions, Dose Increases, or Substitutions
|
0.3 Antihypertensives
Standard Deviation 0.6
|
0.4 Antihypertensives
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Control
n=144 Participants
Control group participants will be provided with a home blood pressure monitoring device (HBMD) (Omron BP761N Bluetooth Smart Automatic Upper Arm Blood Pressure Monitor) and will be instructed in its use at the baseline study visit. Participants will also receive an information sheet describing home blood pressure monitoring that gives advice for how to respond to different home readings. At the baseline visit, participants will be instructed to install an Omron application to their smart phone device (to monitor use of the HBMD). Participants will continue to receive all routine care, including anti-hypertensive medications as prescribed by their regular clinicians.
|
Intervention
n=152 Participants
The intervention group will receive all the interventions provided to the control group. In addition, intervention group participants will install on their mobile phone the hypertension personal control program (HPCP) ("Lark HTN Pro"), which is a smartphone application. The intervention group will have the HPCP installed on their iOS device during their initial office visit (screening/baseline) and will successfully take a reading from their HBMD. The HPCP has blood pressure, medication, and weight monitoring, including periodic reminders for the user to measure blood pressure, measure weight, and take their medication(s). The HPCP provides real-time feedback based on user input, such as out-of-range measurements and has additional features designed to encourage behavior change in areas such as dietary intake, physical activity, sleep, and stress reduction. Users can set goals and receive guidance and feedback through the app.
Lark HTN Pro: The intervention group will have the HPCP
|
|---|---|---|
|
Number of Health System Contacts (Telephone, Office, or Mychart Encounters)
|
7.0 calls
Standard Deviation 11.5
|
6.7 calls
Standard Deviation 6.5
|
SECONDARY outcome
Timeframe: 6 monthsFrequency of home blood pressure measurements per month derived from home blood pressure monitor for months when home monitoring occurred
Outcome measures
| Measure |
Control
n=144 Participants
Control group participants will be provided with a home blood pressure monitoring device (HBMD) (Omron BP761N Bluetooth Smart Automatic Upper Arm Blood Pressure Monitor) and will be instructed in its use at the baseline study visit. Participants will also receive an information sheet describing home blood pressure monitoring that gives advice for how to respond to different home readings. At the baseline visit, participants will be instructed to install an Omron application to their smart phone device (to monitor use of the HBMD). Participants will continue to receive all routine care, including anti-hypertensive medications as prescribed by their regular clinicians.
|
Intervention
n=152 Participants
The intervention group will receive all the interventions provided to the control group. In addition, intervention group participants will install on their mobile phone the hypertension personal control program (HPCP) ("Lark HTN Pro"), which is a smartphone application. The intervention group will have the HPCP installed on their iOS device during their initial office visit (screening/baseline) and will successfully take a reading from their HBMD. The HPCP has blood pressure, medication, and weight monitoring, including periodic reminders for the user to measure blood pressure, measure weight, and take their medication(s). The HPCP provides real-time feedback based on user input, such as out-of-range measurements and has additional features designed to encourage behavior change in areas such as dietary intake, physical activity, sleep, and stress reduction. Users can set goals and receive guidance and feedback through the app.
Lark HTN Pro: The intervention group will have the HPCP
|
|---|---|---|
|
Frequency of Home Blood Pressure Measurements Per Month
|
16 measurements per month
Interval 8.5 to 29.0
|
17 measurements per month
Interval 9.0 to 32.5
|
SECONDARY outcome
Timeframe: 6 monthsNumber of months out of the 6 month study period when at least one home blood pressure reading was obtained
Outcome measures
| Measure |
Control
n=144 Participants
Control group participants will be provided with a home blood pressure monitoring device (HBMD) (Omron BP761N Bluetooth Smart Automatic Upper Arm Blood Pressure Monitor) and will be instructed in its use at the baseline study visit. Participants will also receive an information sheet describing home blood pressure monitoring that gives advice for how to respond to different home readings. At the baseline visit, participants will be instructed to install an Omron application to their smart phone device (to monitor use of the HBMD). Participants will continue to receive all routine care, including anti-hypertensive medications as prescribed by their regular clinicians.
|
Intervention
n=152 Participants
The intervention group will receive all the interventions provided to the control group. In addition, intervention group participants will install on their mobile phone the hypertension personal control program (HPCP) ("Lark HTN Pro"), which is a smartphone application. The intervention group will have the HPCP installed on their iOS device during their initial office visit (screening/baseline) and will successfully take a reading from their HBMD. The HPCP has blood pressure, medication, and weight monitoring, including periodic reminders for the user to measure blood pressure, measure weight, and take their medication(s). The HPCP provides real-time feedback based on user input, such as out-of-range measurements and has additional features designed to encourage behavior change in areas such as dietary intake, physical activity, sleep, and stress reduction. Users can set goals and receive guidance and feedback through the app.
Lark HTN Pro: The intervention group will have the HPCP
|
|---|---|---|
|
Months When a Home Blood Pressure Reading is Obtained, No.
|
4.9 Months
Standard Deviation 1.8
|
5.0 Months
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: 6 monthsSelf reported response to :How confident are you that you will be able to get your blood pressure controlled and keep it there during the next few months? Reponses were on a 5-point scale ranging from (1) not at all confident to (5) extremely confident.
Outcome measures
| Measure |
Control
n=144 Participants
Control group participants will be provided with a home blood pressure monitoring device (HBMD) (Omron BP761N Bluetooth Smart Automatic Upper Arm Blood Pressure Monitor) and will be instructed in its use at the baseline study visit. Participants will also receive an information sheet describing home blood pressure monitoring that gives advice for how to respond to different home readings. At the baseline visit, participants will be instructed to install an Omron application to their smart phone device (to monitor use of the HBMD). Participants will continue to receive all routine care, including anti-hypertensive medications as prescribed by their regular clinicians.
|
Intervention
n=152 Participants
The intervention group will receive all the interventions provided to the control group. In addition, intervention group participants will install on their mobile phone the hypertension personal control program (HPCP) ("Lark HTN Pro"), which is a smartphone application. The intervention group will have the HPCP installed on their iOS device during their initial office visit (screening/baseline) and will successfully take a reading from their HBMD. The HPCP has blood pressure, medication, and weight monitoring, including periodic reminders for the user to measure blood pressure, measure weight, and take their medication(s). The HPCP provides real-time feedback based on user input, such as out-of-range measurements and has additional features designed to encourage behavior change in areas such as dietary intake, physical activity, sleep, and stress reduction. Users can set goals and receive guidance and feedback through the app.
Lark HTN Pro: The intervention group will have the HPCP
|
|---|---|---|
|
Self-efficacy: Confidence in Controlling High Blood Pressure
Confidence in controlling blood pressure
|
4.4 units on a scale
Standard Deviation 0.8
|
4.1 units on a scale
Standard Deviation 0.9
|
|
Self-efficacy: Confidence in Controlling High Blood Pressure
Confidence in using home monitor
|
4.8 units on a scale
Standard Deviation 0.6
|
4.7 units on a scale
Standard Deviation 0.7
|
|
Self-efficacy: Confidence in Controlling High Blood Pressure
Confidence in judging when medication change needed
|
4.0 units on a scale
Standard Deviation 1.3
|
4.0 units on a scale
Standard Deviation 1.2
|
|
Self-efficacy: Confidence in Controlling High Blood Pressure
Confidence in doing nonmedication behaviors to control blood pressure
|
4.4 units on a scale
Standard Deviation 0.9
|
4.4 units on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: 6 monthsBody mass index is calculated as the weight in kilograms divided by height in meters squared.
Outcome measures
| Measure |
Control
n=144 Participants
Control group participants will be provided with a home blood pressure monitoring device (HBMD) (Omron BP761N Bluetooth Smart Automatic Upper Arm Blood Pressure Monitor) and will be instructed in its use at the baseline study visit. Participants will also receive an information sheet describing home blood pressure monitoring that gives advice for how to respond to different home readings. At the baseline visit, participants will be instructed to install an Omron application to their smart phone device (to monitor use of the HBMD). Participants will continue to receive all routine care, including anti-hypertensive medications as prescribed by their regular clinicians.
|
Intervention
n=152 Participants
The intervention group will receive all the interventions provided to the control group. In addition, intervention group participants will install on their mobile phone the hypertension personal control program (HPCP) ("Lark HTN Pro"), which is a smartphone application. The intervention group will have the HPCP installed on their iOS device during their initial office visit (screening/baseline) and will successfully take a reading from their HBMD. The HPCP has blood pressure, medication, and weight monitoring, including periodic reminders for the user to measure blood pressure, measure weight, and take their medication(s). The HPCP provides real-time feedback based on user input, such as out-of-range measurements and has additional features designed to encourage behavior change in areas such as dietary intake, physical activity, sleep, and stress reduction. Users can set goals and receive guidance and feedback through the app.
Lark HTN Pro: The intervention group will have the HPCP
|
|---|---|---|
|
BMI
|
32.0 kg/m^2
Standard Deviation 8.2
|
31.9 kg/m^2
Standard Deviation 7.7
|
SECONDARY outcome
Timeframe: 6 monthsSum of responses represents intake of foods associated with the Dietary Approaches to Stop Hypertension diet. Range is from 0 to 77 with a higher score indicating better diet. Scores 32 and below indicate a low-quality diet, scores 33 to 51 indicate a medium-quality diet, and scores greater than or equal to 52 indicate a high-quality diet.
Outcome measures
| Measure |
Control
n=144 Participants
Control group participants will be provided with a home blood pressure monitoring device (HBMD) (Omron BP761N Bluetooth Smart Automatic Upper Arm Blood Pressure Monitor) and will be instructed in its use at the baseline study visit. Participants will also receive an information sheet describing home blood pressure monitoring that gives advice for how to respond to different home readings. At the baseline visit, participants will be instructed to install an Omron application to their smart phone device (to monitor use of the HBMD). Participants will continue to receive all routine care, including anti-hypertensive medications as prescribed by their regular clinicians.
|
Intervention
n=152 Participants
The intervention group will receive all the interventions provided to the control group. In addition, intervention group participants will install on their mobile phone the hypertension personal control program (HPCP) ("Lark HTN Pro"), which is a smartphone application. The intervention group will have the HPCP installed on their iOS device during their initial office visit (screening/baseline) and will successfully take a reading from their HBMD. The HPCP has blood pressure, medication, and weight monitoring, including periodic reminders for the user to measure blood pressure, measure weight, and take their medication(s). The HPCP provides real-time feedback based on user input, such as out-of-range measurements and has additional features designed to encourage behavior change in areas such as dietary intake, physical activity, sleep, and stress reduction. Users can set goals and receive guidance and feedback through the app.
Lark HTN Pro: The intervention group will have the HPCP
|
|---|---|---|
|
Diet Quality Score (as Assessed by Dietary Approaches to Stop Hypertension Questionnaire, DASH-Q
Dietary Approaches to Stop Hypertension-Questionnaire score
|
38.7 scores on a scale
Standard Deviation 12.1
|
39.3 scores on a scale
Standard Deviation 11.8
|
|
Diet Quality Score (as Assessed by Dietary Approaches to Stop Hypertension Questionnaire, DASH-Q
Consumption of processed meats, d/wk
|
1.3 scores on a scale
Standard Deviation 1.6
|
1.5 scores on a scale
Standard Deviation 1.8
|
|
Diet Quality Score (as Assessed by Dietary Approaches to Stop Hypertension Questionnaire, DASH-Q
Consumption of fried foods, d/wk
|
1.0 scores on a scale
Standard Deviation 1.3
|
1.1 scores on a scale
Standard Deviation 1.4
|
|
Diet Quality Score (as Assessed by Dietary Approaches to Stop Hypertension Questionnaire, DASH-Q
Consumption of sugar-sweetened beverages, d/wk
|
1.7 scores on a scale
Standard Deviation 2.5
|
1.7 scores on a scale
Standard Deviation 2.4
|
|
Diet Quality Score (as Assessed by Dietary Approaches to Stop Hypertension Questionnaire, DASH-Q
Consumption of candy, baked goods, or ice cream, d/wk
|
2.9 scores on a scale
Standard Deviation 2.3
|
2.9 scores on a scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: 6 monthsSelf-reported physical activity in minutes per week of at least moderate exercise
Outcome measures
| Measure |
Control
n=144 Participants
Control group participants will be provided with a home blood pressure monitoring device (HBMD) (Omron BP761N Bluetooth Smart Automatic Upper Arm Blood Pressure Monitor) and will be instructed in its use at the baseline study visit. Participants will also receive an information sheet describing home blood pressure monitoring that gives advice for how to respond to different home readings. At the baseline visit, participants will be instructed to install an Omron application to their smart phone device (to monitor use of the HBMD). Participants will continue to receive all routine care, including anti-hypertensive medications as prescribed by their regular clinicians.
|
Intervention
n=152 Participants
The intervention group will receive all the interventions provided to the control group. In addition, intervention group participants will install on their mobile phone the hypertension personal control program (HPCP) ("Lark HTN Pro"), which is a smartphone application. The intervention group will have the HPCP installed on their iOS device during their initial office visit (screening/baseline) and will successfully take a reading from their HBMD. The HPCP has blood pressure, medication, and weight monitoring, including periodic reminders for the user to measure blood pressure, measure weight, and take their medication(s). The HPCP provides real-time feedback based on user input, such as out-of-range measurements and has additional features designed to encourage behavior change in areas such as dietary intake, physical activity, sleep, and stress reduction. Users can set goals and receive guidance and feedback through the app.
Lark HTN Pro: The intervention group will have the HPCP
|
|---|---|---|
|
Minutes Per Week of Self-reported Physical Activity
|
177.6 minutes/week
Standard Deviation 169.2
|
143.1 minutes/week
Standard Deviation 156.4
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Control
n=144 Participants
Control group participants will be provided with a home blood pressure monitoring device (HBMD) (Omron BP761N Bluetooth Smart Automatic Upper Arm Blood Pressure Monitor) and will be instructed in its use at the baseline study visit. Participants will also receive an information sheet describing home blood pressure monitoring that gives advice for how to respond to different home readings. At the baseline visit, participants will be instructed to install an Omron application to their smart phone device (to monitor use of the HBMD). Participants will continue to receive all routine care, including anti-hypertensive medications as prescribed by their regular clinicians.
|
Intervention
n=152 Participants
The intervention group will receive all the interventions provided to the control group. In addition, intervention group participants will install on their mobile phone the hypertension personal control program (HPCP) ("Lark HTN Pro"), which is a smartphone application. The intervention group will have the HPCP installed on their iOS device during their initial office visit (screening/baseline) and will successfully take a reading from their HBMD. The HPCP has blood pressure, medication, and weight monitoring, including periodic reminders for the user to measure blood pressure, measure weight, and take their medication(s). The HPCP provides real-time feedback based on user input, such as out-of-range measurements and has additional features designed to encourage behavior change in areas such as dietary intake, physical activity, sleep, and stress reduction. Users can set goals and receive guidance and feedback through the app.
Lark HTN Pro: The intervention group will have the HPCP
|
|---|---|---|
|
Self-reported Sleep Duration
|
6.6 sleep hours
Standard Deviation 1.4
|
6.5 sleep hours
Standard Deviation 1.2
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Stephen D. Persell, MD, MPH, FACP
Northwestern University Feinberg School of Medicine
Phone: 312-503-6464
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place