Improve Hypertension Monitoring and Self-management by Using mHealth
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Monitoring and self-management are important components of effective chronic disease care and
      improved patient outcomes. With the rapid development of integration of mobile health
      technology (mHealth) into health care delivery services, mHealth intervention provides a
      great opportunity to improve the efficiency of chronic disease management. However, little is
      known about whether mHealth interventions can effectively impact the health and health care
      outcomes in underserved populations. This pilot study will assess the preliminary
      effectiveness of a mobile-based health intervention in an urban underserved community with a
      high incidence of hypertension. It is hypothesized that patients with hypertension will
      experience improved outcomes due to the use of a mHealth application compared with patients
      who are not using the application. The findings from this study will advance our
      understanding of the utility of mHealth interventions among underserved populations and
      generate evidence to support this new health care delivery approach in underserved urban
      communities.

      In this study, two hypotheses will be tested:

        1. Hypertension patients using the mHealth application exhibit a greater decrease in blood
           pressure and better maintenance over a 6-month period compared to those who receive
           standard care.

        2. Hypertension patients using the mHealth application will exhibit more effective
           self-management as compared to those who receive standard care.
    

Detailed description: 
      Based on the J&HCHC's current practice, all hypotension patients are required to visit the
      nurses for their regular hypertension care every week. Therefore, all participants in this
      study will be asked to visit J&HCHC once a week for the 6-month period as usual. The standard
      follow-up group will receive regular hypertension care as usual which consists: nursing
      assessment, medication management, patient education, follow up and continuing care. Home
      monitoring is a great way to help detect and monitor high blood pressure. The mHealth group
      will ask to use iHealth BP7-Wireless Blood Pressure Wrist Monitor on a daily basis at HOME
      and also will be asked to visit J&HCHC once a week to receive the regular hypertension care
      for the 6-month period as usual. After all participants complete their 6-month study, the
      study data will be collected from Electronic Health Record (McKesson) and patient's mobile
      devices.

      In this study, a FDA 510K approved device, iHealth BP7-Wireless Blood Pressure Wrist Monitor
      (iHealth Lab Inc.), will be utilized for the mHealth group. This is a fully automatic wrist
      cuff blood pressure monitor that uses the oscillometric principle to measure blood pressure
      and pulse rate. The monitor works with mobile devices to test, track and share vital blood
      pressure data. There are no physical risks associated with using this device to take the
      blood pressure at home. Besides the FDA 510K approval, iHealth BP7-Wireless Blood Pressure
      Wrist Monitor has also CE medical certification (Europe) and ESH Certification (European
      Society of Hypertension). iHealth BP7-Wireless Blood Pressure Wrist Monitor works with both
      Apple and Android devices. Apple iOS devices requires iOS version 5.0 or higher and Android
      devices requires operating system 3.0 or later.

      iHealth BP7-Wireless Blood Pressure Wrist Monitor can maintain a maximum of 10,000
      measurements or three years of usage. In addition, iHealth BP7-Wireless Blood Pressure Wrist
      Monitor has a Bluetooth sync system that will pair with both Apple and Android devices. The
      synchronization allows the monitor to send systolic and diastolic blood pressures and pulse
      rate to patients' mobile devices. The free iHealth MyVitals app then automatically keeps a
      history of BP data and gives patient the option to share their blood pressure data
      information with their healthcare provider. In addition to keep the data on the mobile
      device, patient also receive a free and secure cloud account. Vital data on the cloud allows
      patients to access from any computer and to share readings with their healthcare provider, if
      they choose to do so. With this type of information available, patients will be able to do
      self-management and nurses will be able to actively provide intervention activities.
      Conceptual diagram for iHealth BP-7 Wireless Blood Pressure Wrist Monitor device, apps and
      cloud sever are presented in research protocol

      A pilot version of a parallel-group 6-month randomized controlled trial (RCT) will be
      utilized to this study. 30 participants will be randomly assigned either to standard care and
      treatment (the standard follow up group) or to the mobile intervention group (the mHealth
      group). For the standard follow up group, participants' BP will be measured in an upright
      seated position with feet flat on the floor while being at rest for at least 5 minutes.
      During each visit, participants will be measured twice or more, separated by two minutes in
      each arm. The Welch Allyn Spot Vital Signs LXi electronic blood pressure monitor will be
      utilized for this group. Participants' systolic blood pressure (SBP), diastolic blood
      pressure (DBP) and pulse will be measured and recorded by the J&HCHC nurses. For the mHealth
      group participants' BP data will be collected in two ways: iHealth's MyVitals and office
      visit BP records. The office visit BP will be measured in a manner identical to the standard
      follow up group. iHealth's MyVitals BP data were collected by a project research assistant
      every week. Data were aggregated, and an average of the BP readings recorded at baseline
      (beginning of the study), at three months and six months will be used for data analysis.

      BP monitoring adherence for the standard follow-up group will be calculated by dividing the
      total number of office visits to measure BP by the total number of expected visits (one
      office BP measurement every week for 6 months). BP monitoring adherence for the mHealth group
      will be calculated by dividing the total number of times iHealth BP-7 was used to measure BP
      by the total number of expected times it should have been used (one BP measurement performed
      every day for 6 months).

      Improved health related quality of life, patient self-efficacy, and reduced hospital
      utilization will be measured. Medical Outcomes Study 36-Item Short- Form Health Survey
      (SF-36) will be utilized to measure the health-related quality of life. Patient self-efficacy
      and treatment adherence will be measured by the Medication Adherence Self-Efficacy Scale
      (MASES). Self-reported hospital utilization rate will be used to measure reduced hospital
      utilization. Participants hospital utilization data will be retrieved from their electronic
      medical record.
    

Intervention name(s): iHealth BP7-Wireless Blood Pressure Wrist Monitor,
Intervention type(s): Device
Intervention description(s): The mHealth group will ask to use iHealth BP7-Wireless Blood Pressure Wrist Monitor at home. This monitor is a fully automatic wrist cuff blood pressure monitor that uses the oscillometric principle to measure blood pressure and pulse rate. The monitor works with mobile devices to test, track and share vital blood pressure data. The Bluetooth sync system allows the monitor to send BP measures and pulse rate to patients' mobile devices. The free iHealth app automatically keeps a history of BP data and gives patient the option to share their blood pressure data with their provider. In addition to keep the data on the mobile device, patient also receive a free and secure cloud account. Vital data on the cloud allows patients to access from any computer and to share with their provider.
Other intervention name(s): 510(k) number: 121470
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Hypertension; mHealth; underserved community