iSmartHyp: The Smart Hypertension Control Study

• Sponsor: Northwestern University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03288142
• Collaborator: Omron Healthcare Co., Ltd. (Industry)
• Enrollment: 333
• Location: 1
• Arms: 2
• Actual Duration (Months): 26.3
• Patients Per Site Per Month: 12.7

Study Details

Study Description

Brief Summary

Investigators at Northwestern University will partner with Omron Healthcare Co., Ltd. (hereinafter referred to as "Omron") to conduct a randomized controlled trial of a hypertension personal control program (HPCP), known as Lark HTN Pro with a home blood pressure monitoring device (HBMD) compared to a HBMD alone. The overarching goal of this study is to investigate the effects of the HPCP on blood pressure, blood pressure self-management behaviors, and healthy lifestyle behaviors among adults with hypertension.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Other: Hypertension Coaching Application and Home Monitor; Other: Control: Tracking Application and Home Monitor	N/A

Detailed Description

The study team used structured language queries of electronic health record data from the Northwestern Medicine Enterprise Data Warehouse (NMEDW) to identify potentially-eligible participants with elevated blood pressure and exclude patients with clinical exclusion criteria from Northwestern Medical Group outpatient practices. During the on-site visit individuals were asked to provide written informed consent and have blood pressure measured in a standardized fashion to see if this inclusion criteria is met.

We conducted a non-blinded randomized controlled trial among hypertensive adults in NMG outpatient clinics. We randomized participants in a 1:1 fashion to the intervention group (HPCP + HBMD) or the comparator group (HBMD alone). Randomization was performed using a centralized computer-generated assignment sequence uploaded a priori to Northwestern University's REDCap (Research Electronic Data Capture) application. Randomization was stratified by: age (<65 or ≥65 years of age) and baseline systolic blood pressure (<145 or ≥145 mmHg) to optimize the likelihood of obtaining similar populations in each treatment group.

We recruited adults with elevated blood pressure as assessed by in-person standardized examination at baseline. We measured change in blood pressure by in-person examination at 6 months. We recruited between 350 to 400 participants in order to have 333 participants with analyzable data at the time of study completion. If changes were deemed necessary, a revision to the study protocol was submitted to the IRB for review and approval prior to implementing these changes.

Control group participants were 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. Participant also received an information sheet describing home blood pressure monitoring that gives advice for how to respond to different home readings. At the baseline visit, participants were instructed to install an Omron application to their smart phone device (to monitor use of the HBMD). Participants continued to receive all routine care, including anti-hypertensive medications as prescribed by their regular clinicians.

The intervention group received all the interventions provided to the control group. Intervention group participants were sent a hyperlink to install the hypertension personal control program (HPCP) ("Lark HTN Pro"), which is a smartphone application installed on their iOS device during their initial office visit (screening/baseline) and successfully took 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.

Study participants were required to return for a 6-month study visit (within 2 weeks before to 4 weeks after). During the 6-month visit, subjects had their height/weight and blood pressure measured again. Participants also repeated questionnaires related to their current cardiovascular medications. They also completed questionnaires measuring: medication adherence, self-efficacy, diet, physical activity, and sleep duration. An exit survey was provided to participants at the end of the 6-month follow up visit to obtain feedback on Lark and Omron apps usability.

Study Design

• Study Type: Interventional
• Actual Enrollment: 333 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized controlled trial with randomization stratified by age and baseline systolic blood pressure.Randomized controlled trial with randomization stratified by age and baseline systolic blood pressure.
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Improving Hypertension Using a Smartphone-Enabled Personal Control Program: The Smart Hypertension Control Study
• Actual Study Start Date: Sep 21, 2017
• Actual Primary Completion Date: Apr 28, 2019
• Actual Study Completion Date: Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention: 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.	Other: Hypertension Coaching Application and Home Monitor; 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; Other Names: Lark HTN Pro
Active Comparator: Control: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.	Other: Control: 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.

Outcome Measures

Primary Outcome Measures

1. Blood Pressure at 6 Months [6 months]

2. Blood Pressure <140/90mmHg [6 months]

Secondary Outcome Measures

1. Number of Antihypertensive Agents Used [6 months]

   Number of self reported antihypertensive medication drug classes taken

2. Antihypertensive Medication Intensification, No. of Additions, Dose Increases, or Substitutions [6 months]

   Number of antihypertensive drug classes that were increased, added or substituted for another drug class

3. Number of Health System Contacts (Telephone, Office, or Mychart Encounters) [6 months]

4. Frequency of Home Blood Pressure Measurements Per Month [6 months]

   Frequency of home blood pressure measurements per month derived from home blood pressure monitor for months when home monitoring occurred

5. Months When a Home Blood Pressure Reading is Obtained, No. [6 months]

   Number of months out of the 6 month study period when at least one home blood pressure reading was obtained

6. Self-efficacy: Confidence in Controlling High Blood Pressure [6 months]

   Self 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.

7. BMI [6 months]

   Body mass index is calculated as the weight in kilograms divided by height in meters squared.

8. Diet Quality Score (as Assessed by Dietary Approaches to Stop Hypertension Questionnaire, DASH-Q [6 months]

   Sum 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.

9. Minutes Per Week of Self-reported Physical Activity [6 months]

   Self-reported physical activity in minutes per week of at least moderate exercise

10. Self-reported Sleep Duration [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adults aged 18 years to <85 years at the time of screening

• Standardized mean blood pressure measurement ≥135 to <180 mmHg systolic or ≥85 to <110 mmHg diastolic

• Have and use an iOS device(s) (iPhone generation 5s or newer)

• Able to provide written informed consent prior to participation in the study

• Receive their primary care from a Northwestern Medicine clinic site

Exclusion Criteria:

• Current user of the HCPC (Lark HTN Pro)

• Standardized mean blood pressure measurement ≥180 mmHg systolic or ≥110 mmHg diastolic

• Persistent atrial fibrillation as indicated in the electronic health record (EHR)

• Pregnant or planning to become pregnant during the study period

• Severe kidney disease, defined as estimated glomerular filtration rate <30 per 1.73 m2 or currently on renal replacement therapy (i.e. hemodialysis or peritoneal dialysis)

• Hearing impaired and unable to respond to phone calls

• Lack of fluency in English

• History of a cardiovascular event (stroke, transient ischemic attack, myocardial infarction, coronary artery bypass grafting) in the past 3 months

• Diagnosis of dementia as indicated in the electronic health record

• Diagnosis of psychosis as indicated in the electronic health record

• Terminal cancer diagnosis or NYHA III or IV heart failure

• Deemed unsuitable for study by primary care provider

• Individuals requiring BP monitor cuff size larger than 17 inches or 42cm

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern Medical Group	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University
• Omron Healthcare Co., Ltd.

Investigators

• Principal Investigator: Stephen D Persell, MD/MPH, Northwestern Medicine

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 25, 2019

More Information

Publications

None provided.

• Responsible Party: Stephen Persell, MD, MPH, Associate Professor of Medicine, Northwestern University
• ClinicalTrials.gov Identifier: NCT03288142
• Other Study ID Numbers: STU00205025
• First Posted: Sep 19, 2017
• Last Update Posted: Apr 15, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypertension

Study Results

Participant Flow

Arm/Group Title	Hypertension Coaching Application and Home Monitor	Tracking Application and Home Monitor
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	166	167
COMPLETED	144	152
NOT COMPLETED	22	15

Baseline Characteristics

Arm/Group Title	Hypertension Coaching Application and Home Monitor	Tracking Application and Home Monitor	Total
Arm/Group Description	Arm assigned hypertension coaching application and home monitor	Arm assigned tracking application and home monitor	Total of all reporting groups
Overall Participants	144	152	296
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.6 (12.4)	58.3 (13.2)	58.9 (12.8)
Sex: Female, Male (Count of Participants)
Female	91 63.2%	91 59.9%	182 61.5%
Male	53 36.8%	61 40.1%	114 38.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	10 6.9%	13 8.6%	23 7.8%
Not Hispanic or Latino	134 93.1%	139 91.4%	273 92.2%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	4 2.8%	9 5.9%	13 4.4%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	56 38.9%	47 30.9%	103 34.8%
White	73 50.7%	79 52%	152 51.4%
More than one race	11 7.6%	17 11.2%	28 9.5%
Unknown or Not Reported	0 0%	0 0%	0 0%
Education (Count of Participants)
Less thank HS graduate	3 2.1%	2 1.3%	5 1.7%
Grade 12 or GED	10 6.9%	16 10.5%	26 8.8%
College 1-3y	27 18.8%	28 18.4%	55 18.6%
College≥4	103 71.5%	106 69.7%	209 70.6%
Unknown	1 0.7%	0 0%	1 0.3%
Primary Language (Count of Participants)
English	141 97.9%	143 94.1%	284 95.9%
Other	3 2.1%	8 5.3%	11 3.7%
Refused	0 0%	1 0.7%	1 0.3%
No. of antihypertensive agents used (Count of Participants)
0	34 23.6%	53 34.9%	87 29.4%
1	61 42.4%	44 28.9%	105 35.5%
2	35 24.3%	40 26.3%	75 25.3%
≥3	14 9.7%	15 9.9%	29 9.8%
Body mass index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	31.9 (8.3)	31.7 (7.8)	31.8 (8.0)

Outcome Measures

1. Primary Outcome

Title	Blood Pressure at 6 Months
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Intervention
Arm/Group Description	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.	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
Measure Participants	144	152
Systolic BP	135.0 (13.9)	132.3 (15.0)
Diastolic BP	85.6 (9.8)	85.1 (9.6)

2. Primary Outcome

Title	Blood Pressure <140/90mmHg
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Intervention
Arm/Group Description	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.	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
Measure Participants	144	152
Count of Participants [Participants]	72 50%	78 51.3%

3. Secondary Outcome

Title	Number of Antihypertensive Agents Used
Description	Number of self reported antihypertensive medication drug classes taken
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Control
Arm/Group Description	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	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.
Measure Participants	144	152
Mean (Standard Deviation) [Antihypertensives]	1.3 (1.0)	1.3 (1.2)

4. Secondary Outcome

Title	Antihypertensive Medication Intensification, No. of Additions, Dose Increases, or Substitutions
Description	Number of antihypertensive drug classes that were increased, added or substituted for another drug class
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Control
Arm/Group Description	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	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.
Measure Participants	144	152
Mean (Standard Deviation) [Antihypertensives]	0.3 (0.6)	0.4 (0.8)

5. Secondary Outcome

Title	Number of Health System Contacts (Telephone, Office, or Mychart Encounters)
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Control
Arm/Group Description	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	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.
Measure Participants	144	152
Mean (Standard Deviation) [calls]	7.0 (11.5)	6.7 (6.5)

6. Secondary Outcome

Title	Frequency of Home Blood Pressure Measurements Per Month
Description	Frequency of home blood pressure measurements per month derived from home blood pressure monitor for months when home monitoring occurred
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Control
Arm/Group Description	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	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.
Measure Participants	144	152
Median (Inter-Quartile Range) [measurements per month]	16	17

7. Secondary Outcome

Title	Months When a Home Blood Pressure Reading is Obtained, No.
Description	Number of months out of the 6 month study period when at least one home blood pressure reading was obtained
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Control
Arm/Group Description	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	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.
Measure Participants	144	152
Mean (Standard Deviation) [Months]	4.9 (1.8)	5.0 (1.8)

8. Secondary Outcome

Title	Self-efficacy: Confidence in Controlling High Blood Pressure
Description	Self 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.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Control
Arm/Group Description	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	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.
Measure Participants	144	152
Confidence in controlling blood pressure	4.4 (0.8)	4.1 (0.9)
Confidence in using home monitor	4.8 (0.6)	4.7 (0.7)
Confidence in judging when medication change needed	4.0 (1.3)	4.0 (1.2)
Confidence in doing nonmedication behaviors to control blood pressure	4.4 (0.9)	4.4 (0.9)

9. Secondary Outcome

Title	BMI
Description	Body mass index is calculated as the weight in kilograms divided by height in meters squared.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Control
Arm/Group Description	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	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.
Measure Participants	144	152
Mean (Standard Deviation) [kg/m^2]	32.0 (8.2)	31.9 (7.7)

10. Secondary Outcome

Title	Diet Quality Score (as Assessed by Dietary Approaches to Stop Hypertension Questionnaire, DASH-Q
Description	Sum 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.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Control
Arm/Group Description	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	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.
Measure Participants	144	152
Dietary Approaches to Stop Hypertension-Questionnaire score	38.7 (12.1)	39.3 (11.8)
Consumption of processed meats, d/wk	1.3 (1.6)	1.5 (1.8)
Consumption of fried foods, d/wk	1.0 (1.3)	1.1 (1.4)
Consumption of sugar-sweetened beverages, d/wk	1.7 (2.5)	1.7 (2.4)
Consumption of candy, baked goods, or ice cream, d/wk	2.9 (2.3)	2.9 (2.2)

11. Secondary Outcome

Title	Minutes Per Week of Self-reported Physical Activity
Description	Self-reported physical activity in minutes per week of at least moderate exercise
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Control
Arm/Group Description	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	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.
Measure Participants	144	152
Mean (Standard Deviation) [minutes/week]	177.6 (169.2)	143.1 (156.4)

12. Secondary Outcome

Title	Self-reported Sleep Duration
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Control
Arm/Group Description	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	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.
Measure Participants	144	152
Mean (Standard Deviation) [sleep hours]	6.6 (1.4)	6.5 (1.2)

Adverse Events

Time Frame	1 year
Adverse Event Reporting Description	We assessed adverse events for the duration of the duration of the study. We are not aware of any serious adverse events or deaths and had no events reported to study personnel during the study period. Because no adverse events were reported, we noted this in the required section but want readers to be aware that adverse events were not retorted by any participant to study team.
Arm/Group Title	Intervention		Control
Arm/Group Description	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.		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.
All Cause Mortality
	Intervention		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/166 (0%)		0/167 (0%)
Serious Adverse Events
	Intervention		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/166 (0%)		0/167 (0%)
Other (Not Including Serious) Adverse Events
	Intervention		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/166 (0%)		0/167 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.