Virtual Hypertension Clinic (VHC)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01167920
First received: July 14, 2010
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Hypertension
Other: Virtual Hypertension Clinic

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Virtual Hypertension Clinic (VHC) Study

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • changes in home diastolic, systolic, and mean arterial blood pressure [ Time Frame: week 0 (screening) and week 15(final week) ] [ Designated as safety issue: No ]
    BP taken at home twice a day (morning and evening) Comparison of the average of the screening week's (Week 0)home blood pressure measurements with the average of the final week's (Week 15) home blood pressure measurements for each participant. Mean arterial blood pressure measurement values obtained at Clinic Visit One and Clinic Visit Two will be compared


Secondary Outcome Measures:
  • The proportion at the end of the study of participants in each group with controlled hypertension based on average home diastolic and systolic blood pressures transmitted by Stabil-o-Graph (averaged over each 2 week interval during the study period). [ Time Frame: Week 0(screening) and Week 15 (final) ] [ Designated as safety issue: No ]
    Comparison of the average of the screening week's (Week 0)home blood pressure measurements with the average of the final week's (Week 15) home blood pressure measurements for each participant.


Estimated Enrollment: 74
Study Start Date: November 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Virtual Hypertension Clinic Group
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 till the end of the study.
Other: Virtual Hypertension Clinic
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 Names:
  • ACE Inhibitors
  • Angiotensin II Receptors
  • Calcium Channel Blockers
  • Renin Inhibitors
  • Diuretics
  • BetaBlockers
  • AlphaBlockers
  • Vasodilators
No Intervention: Usual Care Group
The Usual Care Group (UCG) patients will be told their BP is not in control and encouraged to work with their physician to improve it. There will be no further structured intervention during the rest of the study.

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.

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 25-65 years with essential hypertension
  • Poorly controlled Hypertension (Systolic BP 140-199 Diastolic BP 90-110 mmHg

Exclusion Criteria:

  • Patient on 4 or more antihypertensive medications
  • History of non compliance with medications
  • If extra-large cuff cannot fit the arm
  • Patient with estimated glomerular filtration of less than 30 ml/min in the past two years)
  • Patients with acute glomerulonephritis
  • Patient with secondary hypertension
  • Patient with severe congestive heart failure (New York Heart Association Functional Classification Class III AND IV)
  • Patient with cirrhosis
  • Patients with terminal diseases like cancers (other than non-melanoma skin cancers)
  • Excessive alcohol intake (> 7 servings/week)
  • Sensitivity or contra-indications to the use of 2 or more classes of antihypertensive medications
  • Women who are pregnant (self reported) or lactating
  • Women on oral contraceptive pills
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01167920

Locations
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Mohammed Rafey, MD The Cleveland Clinic
  More Information

Publications:
Cherry DK, Burt CW, Woodwell DA. National Ambulatory Medical Care Survey: 2001 summary. Adv Data. Aug 11 2003(337):1-44.

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01167920     History of Changes
Other Study ID Numbers: 09-575
Study First Received: July 14, 2010
Last Updated: July 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
High Blood Pressure
Hypertension
Home Blood Pressure Measurements
Wireless communication of measurements
Wireless communication of blood pressure measurements

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Angiotensin II
Angiotensin-Converting Enzyme Inhibitors
Calcium Channel Blockers
Vasodilator Agents
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Membrane Transport Modulators

ClinicalTrials.gov processed this record on April 16, 2014