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| Name | Class |
|---|---|
| Omron Healthcare Co., Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention: Hypertension Coaching Application and Home Monitor: | Experimental | 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:Tracking Application and Home Monitor: | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypertension Coaching Application and Home Monitor | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure at 6 Months | 6 months | |
| Blood Pressure <140/90mmHg | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Antihypertensive Agents Used | Number of self reported antihypertensive medication drug classes taken | 6 months |
| Antihypertensive Medication Intensification, No. of Additions, Dose Increases, or Substitutions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen D Persell, MD/MPH | Northwestern Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Medical Group | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32119093 | Derived | Persell SD, Peprah YA, Lipiszko D, Lee JY, Li JJ, Ciolino JD, Karmali KN, Sato H. Effect of Home Blood Pressure Monitoring via a Smartphone Hypertension Coaching Application or Tracking Application on Adults With Uncontrolled Hypertension: A Randomized Clinical Trial. JAMA Netw Open. 2020 Mar 2;3(3):e200255. doi: 10.1001/jamanetworkopen.2020.0255. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Hypertension Coaching Application and Home Monitor | Arm assigned hypertension coaching application and home monitor |
| BG001 | Tracking Application and Home Monitor | Arm assigned tracking application and home monitor |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 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. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Blood Pressure at 6 Months | Posted | Mean | Standard Deviation | mmHG | 6 months |
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1 year
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephen D. Persell, MD, MPH, FACP | Northwestern University Feinberg School of Medicine | 312-503-6464 | spersell@nm.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 25, 2019 | Sep 25, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Randomized controlled trial with randomization stratified by age and baseline systolic blood pressure.
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|
| Control: Tracking Application and Home Monitor | Other | 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. |
|
Number of antihypertensive drug classes that were increased, added or substituted for another drug class
| 6 months |
| Number of Health System Contacts (Telephone, Office, or Mychart Encounters) | 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 | 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 | 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. | 6 months |
| BMI | Body mass index is calculated as the weight in kilograms divided by height in meters squared. | 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. | 6 months |
| Minutes Per Week of Self-reported Physical Activity | Self-reported physical activity in minutes per week of at least moderate exercise | 6 months |
| Self-reported Sleep Duration | 6 months |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | 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. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | 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. | Count of Participants | Participants |
|
| Race (NIH/OMB) | 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. | Count of Participants | Participants |
|
| Education | 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. | Count of Participants | Participants |
|
| Primary Language | 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. | Count of Participants | Participants |
|
| No. of antihypertensive agents used | 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. | Count of Participants | Participants |
|
| Body mass index | weight in kilograms divided by height in meters squared. | 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. | Mean | Standard Deviation | kg/m^2 |
|
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
|
|
| Primary | Blood Pressure <140/90mmHg | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Number of Antihypertensive Agents Used | Number of self reported antihypertensive medication drug classes taken | Posted | Mean | Standard Deviation | Antihypertensives | 6 months |
|
|
|
| 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 | Posted | Mean | Standard Deviation | Antihypertensives | 6 months |
|
|
|
| Secondary | Number of Health System Contacts (Telephone, Office, or Mychart Encounters) | Posted | Mean | Standard Deviation | calls | 6 months |
|
|
|
| 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 | Posted | Median | Inter-Quartile Range | measurements per month | 6 months |
|
|
|
| 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 | Posted | Mean | Standard Deviation | Months | 6 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
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| Secondary | BMI | Body mass index is calculated as the weight in kilograms divided by height in meters squared. | Posted | Mean | Standard Deviation | kg/m^2 | 6 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | scores on a scale | 6 months |
|
|
|
| Secondary | Minutes Per Week of Self-reported Physical Activity | Self-reported physical activity in minutes per week of at least moderate exercise | Posted | Mean | Standard Deviation | minutes/week | 6 months |
|
|
|
| Secondary | Self-reported Sleep Duration | Posted | Mean | Standard Deviation | sleep hours | 6 months |
|
|
|
| 0 |
| 166 |
| 0 |
| 166 |
| 0 |
| 166 |
| EG001 | Control | 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. | 0 | 167 | 0 | 167 | 0 | 167 |
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| Confidence in judging when medication change needed |
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| Confidence in doing nonmedication behaviors to control blood pressure |
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| Consumption of fried foods, d/wk |
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| Consumption of sugar-sweetened beverages, d/wk |
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| Consumption of candy, baked goods, or ice cream, d/wk |
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