Virtual Hypertension Clinic (VHC) Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- The Cleveland Clinic
- Enrollment
- 74
- Locations
- 2
- Primary Endpoint
- changes in home diastolic, systolic, and mean arterial blood pressure
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
changes in home diastolic, systolic, and mean arterial blood pressure
Time Frame: week 0 (screening) and week 15(final week)
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 Outcomes
- 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).(Week 0(screening) and Week 15 (final))