Virtual Hypertension Clinic
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      This is a prospective, randomized controlled trial designed to determine whether blue tooth
      and telephone technology can be utilized to successfully relaying home blood pressure
      information electronically to healthcare providers so that timely and more frequent treatment
      interventions can be instituted to optimize and reach goal blood pressure level for an
      individual as compared to usual care. The primary study outcomes are improvement in systolic,
      diastolic, and blood pressure control and time to control blood pressure. Secondary outcomes
      are proportion of patients controlled to blood pressure goal at the end of the study,
      adherence to blood pressure monitoring and utilization of VHC model.

      If this is successful and cost-effective such technology and interventions could be utilized
      on large scale to improve the care and proportion of hypertensive patients achieving goal
      blood pressure in the United States.
    

Detailed description: 
      Hypertension is a major risk factor for renal and cardiovascular disease, and a significant
      contributor to adult disability. About 50 million individuals are hypertensive in the United
      States1. The Framingham Heart Study suggests that normotensive individuals at 55 years have a
      90% lifetime risk of hypertension2. Treatment of hypertension is the leading reason for
      physician visits and prescription drugs in the US3. Despite increasing awareness of the risks
      and of complications of poorly controlled hypertension, only 58% of hypertensive patients are
      being treated and of these only 38% achieve blood pressure control4, 5. Sub-optimal therapy
      remains the most common cause for uncontrolled hypertension6. One of the major barriers to
      effective management of hypertension is therapeutic inertia on the part of physicians that
      leads to suboptimal therapy being prescribed for hypertensive patients7.

      This barrier to effective hypertension treatment achieves further significance as data from
      several clinical trials clearly demonstrate that reduction of blood pressure by even a few
      millimeters of mercury can significantly decrease an individual risk for mortality from
      cardiovascular disease8.

      Although hypertension remains the most common reason for patient visit to a physician office
      in the United States, the lack of patient-health care provider connectivity outside the
      office setting may play an important factor in the disappointing proportion of patients
      achieving blood pressure control in the US for the past 30 years.

      Recent home blood pressure monitoring guidelines published by the American Heart Association
      and other professional societies have emphasized the importance of home blood pressure
      monitoring in the management of hypertension9. In addition, a recent study by Green et al
      extended this concept a step further by utilizing a web based intervention utilized by a
      pharmacist to control blood pressure10. Results from this study they demonstrated a
      significant reduction in blood pressure in the intervention group when compared to usual care
      (-14.2 mmHg Vs -5.3 mmHg p <0.001).

      One of the potential draw backs of a web based intervention for blood pressure control could
      be the lack of access to internet in the general population. According to a recent USDA
      report, almost 40% Americans in urban areas and 60% in rural areas do not have internet
      access (http://arstechnica.com/tech-policy/news/2009/03/the-many-blessing-of-rural.ars ).
      This in essence would deprive a large number of those with hypertension from access to the
      web based newer models of blood pressure control as tested in the recent study by Green et
      al.

      The Stabil-o-Graph is a validated home blood pressure device
      (http://www.dableducational.org/dabl_library/library2_sbpm.html#upper_arm) that relays blood
      pressure readings to a designated health care provider using blue tooth technology and a
      telephone connection

      The current model of health care in the US for the management of hypertension employs direct
      patient-physician encounters in an office setting to control blood pressure. This existing
      healthcare model has failed to keep abreast with current national guidelines and consensus
      among experts in hypertension that promote home blood pressure monitoring and application of
      newer technology with the potential to seamlessly connect a patient with his health care
      provider with the goal of improved blood pressure control.

      Our proposed study aims to address this gap in patient-healthcare provider connectivity
      utilizing newer technology and home blood pressure monitoring to achieve goal blood pressure
      foe an individual.
    

Intervention name(s): Virtual Hypertension Clinic
Intervention type(s): Other
Intervention description(s): In the VHC group, patients will be ask to regularly measure blood pressure with the Stabil-o-Graph so that these readings are transmitted to Virtual Hypertension Clinic. The data will be reviewed weekly and the patient will receive feedback and intervention if needed at every 2 week interval to achieve blood pressure goal. Once they reach goal, the feedback will be less intense and given at four week intervals until the end of the study.
Other intervention name(s): ACE Inhibitors; Angiotensin II Receptors; Calcium Channel Blockers; Renin Inhibitors; Diuretics; BetaBlockers; AlphaBlockers; Vasodilators
Intervention MeSH terms: Calcium Channel Blockers; Angiotensin II; Diuretics; Angiotensin-Converting Enzyme Inhibitors; Renin Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: High Blood Pressure; Hypertension; Home Blood Pressure Measurements; Wireless communication of measurements; Wireless communication of blood pressure measurements