An interventional study of Hypertension Coaching Application and Home Monitor and Control: Tracking Application and Home Monitor in Hypertension, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2022-04-15.
Sponsored by Northwestern University · Not applicable, Interventional, and Other
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.
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.
Exclusion Criteria:
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
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
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
Also known as: Lark HTN Pro
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.
Blood Pressure at 6 Months
Time frame: 6 months
Blood Pressure <140/90mmHg
Time frame: 6 months
Number of Antihypertensive Agents Used
Number of self reported antihypertensive medication drug classes taken
Time frame: 6 months
Antihypertensive Medication Intensification, No. of Additions, Dose Increases, or Substitutions
Number of antihypertensive drug classes that were increased, added or substituted for another drug class
Time frame: 6 months
Number of Health System Contacts (Telephone, Office, or Mychart Encounters)
Time frame: 6 months
Frequency of Home Blood Pressure Measurements Per Month
Frequency of home blood pressure measurements per month derived from home blood pressure monitor for months when home monitoring occurred
Time frame: 6 months
Months When a Home Blood Pressure Reading is Obtained, No.
Number of months out of the 6 month study period when at least one home blood pressure reading was obtained
Time frame: 6 months
Self-efficacy: Confidence in Controlling High Blood Pressure
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
BMI
Body mass index is calculated as the weight in kilograms divided by height in meters squared.
Time frame: 6 months
Diet Quality Score (as Assessed by Dietary Approaches to Stop Hypertension Questionnaire, DASH-Q
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
Minutes Per Week of Self-reported Physical Activity
Self-reported physical activity in minutes per week of at least moderate exercise
Time frame: 6 months
Self-reported Sleep Duration
Time frame: 6 months
| Milestone | Hypertension Coaching Application and Home Monitor | Tracking Application and Home Monitor |
|---|---|---|
| Started | 166 | 167 |
| Completed | 144 | 152 |
| Not completed | 22 | 15 |
| Withdrew: Lost to follow-up | 22 | 15 |
| mmHG | Control | Intervention |
|---|---|---|
| Systolic BP | 135.0 ± 13.9 | 132.3 ± 15.0 |
| Diastolic BP | 85.6 ± 9.8 | 85.1 ± 9.6 |
| Participants | Control | Intervention |
|---|---|---|
| Blood Pressure <140/90mmHg | 72 | 78 |
Number of self reported antihypertensive medication drug classes taken
| Antihypertensives | Intervention | Control |
|---|---|---|
| Number of Antihypertensive Agents Used | 1.3 ± 1.0 | 1.3 ± 1.2 |
Number of antihypertensive drug classes that were increased, added or substituted for another drug class
| Antihypertensives | Intervention | Control |
|---|---|---|
| Antihypertensive Medication Intensification, No. of Additions, Dose Increases, or Substitutions | 0.3 ± 0.6 | 0.4 ± 0.8 |
| calls | Intervention | Control |
|---|---|---|
| Number of Health System Contacts (Telephone, Office, or Mychart Encounters) | 7.0 ± 11.5 | 6.7 ± 6.5 |
Frequency of home blood pressure measurements per month derived from home blood pressure monitor for months when home monitoring occurred
| measurements per month | Intervention | Control |
|---|---|---|
| Frequency of Home Blood Pressure Measurements Per Month | 16 (8.5 to 29) | 17 (9 to 32.5) |
Number of months out of the 6 month study period when at least one home blood pressure reading was obtained
| Months | Intervention | Control |
|---|---|---|
| Months When a Home Blood Pressure Reading is Obtained, No. | 4.9 ± 1.8 | 5.0 ± 1.8 |
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.
| units on a scale | Intervention | Control |
|---|---|---|
| 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 |
Body mass index is calculated as the weight in kilograms divided by height in meters squared.
| kg/m^2 | Intervention | Control |
|---|---|---|
| BMI | 32.0 ± 8.2 | 31.9 ± 7.7 |
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.
| scores on a scale | Intervention | Control |
|---|---|---|
| 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 |
Self-reported physical activity in minutes per week of at least moderate exercise
| minutes/week | Intervention | Control |
|---|---|---|
| Minutes Per Week of Self-reported Physical Activity | 177.6 ± 169.2 | 143.1 ± 156.4 |
| sleep hours | Intervention | Control |
|---|---|---|
| Self-reported Sleep Duration | 6.6 ± 1.4 | 6.5 ± 1.2 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | 0/166 (0%) | 0/166 (0%) | 0/166 (0%) |
| Control | 0/167 (0%) | 0/167 (0%) | 0/167 (0%) |
166 participants contributed data for the hypertension coaching application arm of the study. 167 participants from the tracking application arm contributed data to the study. Overall number of participants is 333. 22 participants from intervention arm were excluded from analyses for various reasons leaving 144 participants for analyses.1 missing data and 14 participants were lost to follow up and were excluded from analyses in the control arm which leaves us with 153 participants for analyses.
| Age, Continuous(years) | Hypertension Coaching Application and Home Monitor | Tracking Application and Home Monitor | Total |
|---|---|---|---|
| Mean | 59.6 ± 12.4 | 58.3 ± 13.2 | 58.9 ± 12.8 |
| Sex: Female, Male(Participants) | Hypertension Coaching Application and Home Monitor | Tracking Application and Home Monitor | Total |
|---|---|---|---|
| Female | 91 | 91 | 182 |
| Male | 53 | 61 | 114 |
| Ethnicity (NIH/OMB)(Participants) | Hypertension Coaching Application and Home Monitor | Tracking Application and Home Monitor | Total |
|---|---|---|---|
| Hispanic or Latino | 10 | 13 | 23 |
| Not Hispanic or Latino | 134 | 139 | 273 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Hypertension Coaching Application and Home Monitor | Tracking Application and Home Monitor | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 4 | 9 | 13 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 56 | 47 | 103 |
| White | 73 | 79 | 152 |
| More than one race | 11 | 17 | 28 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Education(Participants) | Hypertension Coaching Application and Home Monitor | Tracking Application and Home Monitor | Total |
|---|---|---|---|
| Less thank HS graduate | 3 | 2 | 5 |
| Grade 12 or GED | 10 | 16 | 26 |
| College 1-3y | 27 | 28 | 55 |
| College≥4 | 103 | 106 | 209 |
| Unknown | 1 | 0 | 1 |
| Primary Language(Participants) | Hypertension Coaching Application and Home Monitor | Tracking Application and Home Monitor | Total |
|---|---|---|---|
| English | 141 | 143 | 284 |
| Other | 3 | 8 | 11 |
| Refused | 0 | 1 | 1 |
| No. of antihypertensive agents used(Participants) | Hypertension Coaching Application and Home Monitor | Tracking Application and Home Monitor | Total |
|---|---|---|---|
| 0 | 34 | 53 | 87 |
| 1 | 61 | 44 | 105 |
| 2 | 35 | 40 | 75 |
| ≥3 | 14 | 15 | 29 |
| Body mass index(kg/m^2) | Hypertension Coaching Application and Home Monitor | Tracking Application and Home Monitor | Total |
|---|---|---|---|
| Mean | 31.9 ± 8.3 | 31.7 ± 7.8 | 31.8 ± 8.0 |
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