The Smart Hypertension Control Study
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

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.
    

Intervention name(s): Hypertension Coaching Application and Home Monitor; Control: Tracking Application and Home Monitor
Intervention type(s): Other; Other
Intervention description(s): 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; 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 intervention name(s): Lark HTN Pro
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial with randomization stratified by age and baseline systolic blood pressure.
Masking: None (Open Label)
Primary purpose: Other