Hypertension
Conditions
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.
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.
Interventions
OTHERHypertension 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
OTHERControl: 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.
Sponsors
Omron Healthcare Co., Ltd.
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Randomized controlled trial with randomization stratified by age and baseline systolic blood pressure.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood Pressure at 6 Months | 6 months |
| Blood Pressure <140/90mmHg | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Number of Health System Contacts (Telephone, Office, or Mychart Encounters) | 6 months | — |
| 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 |
| 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 |
| Minutes Per Week of Self-reported Physical Activity | 6 months | Self-reported physical activity in minutes per week of at least moderate exercise |
| BMI | 6 months | Body mass index is calculated as the weight in kilograms divided by height in meters squared. |
| 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. |
| Self-reported Sleep Duration | 6 months | — |
| 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. |
| Number of Antihypertensive Agents Used | 6 months | Number of self reported antihypertensive medication drug classes taken |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hypertension Coaching Application and Home Monitor Arm assigned hypertension coaching application and home monitor | 144 |
| Tracking Application and Home Monitor Arm assigned tracking application and home monitor | 152 |
| Total | 296 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 22 | 15 |
Baseline characteristics
| Characteristic | Total | Tracking Application and Home Monitor | Hypertension Coaching Application and Home Monitor |
|---|---|---|---|
| Age, Continuous | 58.9 years STANDARD_DEVIATION 12.8 | 58.3 years STANDARD_DEVIATION 13.2 | 59.6 years STANDARD_DEVIATION 12.4 |
| Body mass index | 31.8 kg/m^2 STANDARD_DEVIATION 8 | 31.7 kg/m^2 STANDARD_DEVIATION 7.8 | 31.9 kg/m^2 STANDARD_DEVIATION 8.3 |
| Education College 1-3y | 55 Participants | 28 Participants | 27 Participants |
| Education College≥4 | 209 Participants | 106 Participants | 103 Participants |
| Education Grade 12 or GED | 26 Participants | 16 Participants | 10 Participants |
| Education Less thank HS graduate | 5 Participants | 2 Participants | 3 Participants |
| Education Unknown | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 23 Participants | 13 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 273 Participants | 139 Participants | 134 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| No. of antihypertensive agents used 0 | 87 Participants | 53 Participants | 34 Participants |
| No. of antihypertensive agents used 1 | 105 Participants | 44 Participants | 61 Participants |
| No. of antihypertensive agents used 2 | 75 Participants | 40 Participants | 35 Participants |
| No. of antihypertensive agents used ≥3 | 29 Participants | 15 Participants | 14 Participants |
| Primary Language English | 284 Participants | 143 Participants | 141 Participants |
| Primary Language Other | 11 Participants | 8 Participants | 3 Participants |
| Primary Language Refused | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 13 Participants | 9 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 103 Participants | 47 Participants | 56 Participants |
| Race (NIH/OMB) More than one race | 28 Participants | 17 Participants | 11 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 152 Participants | 79 Participants | 73 Participants |
| Sex: Female, Male Female | 182 Participants | 91 Participants | 91 Participants |
| Sex: Female, Male Male | 114 Participants | 61 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 166 | 0 / 167 |
| other Total, other adverse events | 0 / 166 | 0 / 167 |
| serious Total, serious adverse events | 0 / 166 | 0 / 167 |
Outcome results
Primary
Blood Pressure <140/90mmHg
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Blood Pressure <140/90mmHg | 72 Participants |
| Intervention | Blood Pressure <140/90mmHg | 78 Participants |
Primary
Blood Pressure at 6 Months
Time frame: 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Blood Pressure at 6 Months | Systolic BP | 135.0 mmHG | Standard Deviation 13.9 |
| Control | Blood Pressure at 6 Months | Diastolic BP | 85.6 mmHG | Standard Deviation 9.8 |
| Intervention | Blood Pressure at 6 Months | Systolic BP | 132.3 mmHG | Standard Deviation 15 |
| Intervention | Blood Pressure at 6 Months | Diastolic BP | 85.1 mmHG | Standard Deviation 9.6 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Antihypertensive Medication Intensification, No. of Additions, Dose Increases, or Substitutions | 0.3 Antihypertensives | Standard Deviation 0.6 |
| Intervention | Antihypertensive Medication Intensification, No. of Additions, Dose Increases, or Substitutions | 0.4 Antihypertensives | Standard Deviation 0.8 |
Secondary
BMI
Body mass index is calculated as the weight in kilograms divided by height in meters squared.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | BMI | 32.0 kg/m^2 | Standard Deviation 8.2 |
| Intervention | BMI | 31.9 kg/m^2 | Standard Deviation 7.7 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | 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 |
| Control | 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 |
| Control | 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 |
| Control | 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 |
| Control | 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 |
| Intervention | 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 2.2 |
| Intervention | Diet Quality Score (as Assessed by Dietary Approaches to Stop Hypertension Questionnaire, DASH-Q | Consumption of fried foods, d/wk | 1.1 scores on a scale | Standard Deviation 1.4 |
| Intervention | Diet Quality Score (as Assessed by Dietary Approaches to Stop Hypertension Questionnaire, DASH-Q | Dietary Approaches to Stop Hypertension-Questionnaire score | 39.3 scores on a scale | Standard Deviation 11.8 |
| Intervention | 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 2.4 |
| Intervention | Diet Quality Score (as Assessed by Dietary Approaches to Stop Hypertension Questionnaire, DASH-Q | Consumption of processed meats, d/wk | 1.5 scores on a scale | Standard Deviation 1.8 |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Frequency of Home Blood Pressure Measurements Per Month | 16 measurements per month |
| Intervention | Frequency of Home Blood Pressure Measurements Per Month | 17 measurements per month |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Minutes Per Week of Self-reported Physical Activity | 177.6 minutes/week | Standard Deviation 169.2 |
| Intervention | Minutes Per Week of Self-reported Physical Activity | 143.1 minutes/week | Standard Deviation 156.4 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Months When a Home Blood Pressure Reading is Obtained, No. | 4.9 Months | Standard Deviation 1.8 |
| Intervention | Months When a Home Blood Pressure Reading is Obtained, No. | 5.0 Months | Standard Deviation 1.8 |
Secondary
Number of Antihypertensive Agents Used
Number of self reported antihypertensive medication drug classes taken
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Number of Antihypertensive Agents Used | 1.3 Antihypertensives | Standard Deviation 1 |
| Intervention | Number of Antihypertensive Agents Used | 1.3 Antihypertensives | Standard Deviation 1.2 |
Secondary
Number of Health System Contacts (Telephone, Office, or Mychart Encounters)
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Number of Health System Contacts (Telephone, Office, or Mychart Encounters) | 7.0 calls | Standard Deviation 11.5 |
| Intervention | Number of Health System Contacts (Telephone, Office, or Mychart Encounters) | 6.7 calls | Standard Deviation 6.5 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Self-efficacy: Confidence in Controlling High Blood Pressure | Confidence in controlling blood pressure | 4.4 units on a scale | Standard Deviation 0.8 |
| Control | Self-efficacy: Confidence in Controlling High Blood Pressure | Confidence in using home monitor | 4.8 units on a scale | Standard Deviation 0.6 |
| Control | 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 |
| Control | 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 |
| Intervention | 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 |
| Intervention | Self-efficacy: Confidence in Controlling High Blood Pressure | Confidence in controlling blood pressure | 4.1 units on a scale | Standard Deviation 0.9 |
| Intervention | Self-efficacy: Confidence in Controlling High Blood Pressure | Confidence in judging when medication change needed | 4.0 units on a scale | Standard Deviation 1.2 |
| Intervention | Self-efficacy: Confidence in Controlling High Blood Pressure | Confidence in using home monitor | 4.7 units on a scale | Standard Deviation 0.7 |
Secondary
Self-reported Sleep Duration
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Self-reported Sleep Duration | 6.6 sleep hours | Standard Deviation 1.4 |
| Intervention | Self-reported Sleep Duration | 6.5 sleep hours | Standard Deviation 1.2 |