Virtual Hypertension Clinic

NCT01167920 | Completed

• 1 other identifier: 09-575
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

High Blood Pressure; Hypertension; Home Blood Pressure Measurements; Wireless communication of measurements; Wireless communication of blood pressure measurements

Outcome Measures

Primary Outcomes (1)

• changes in home diastolic, systolic, and mean arterial blood pressure

  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

  week 0 (screening) and week 15(final week)

Secondary Outcomes (1)

• 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)

Study Arms (2)

Virtual Hypertension Clinic Group

ACTIVE COMPARATOR

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

Usual Care Group

NO INTERVENTION

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.

Interventions

Virtual Hypertension Clinic OTHER

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.

Also known as: ACE Inhibitors, Angiotensin II Receptors, Calcium Channel Blockers, Renin Inhibitors, Diuretics, BetaBlockers, AlphaBlockers, Vasodilators

Virtual Hypertension Clinic Group

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Related Publications (11)

• Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ; Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. National Heart, Lung, and Blood Institute; National High Blood Pressure Education Program Coordinating Committee. Seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Hypertension. 2003 Dec;42(6):1206-52. doi: 10.1161/01.HYP.0000107251.49515.c2. Epub 2003 Dec 1.

  PMID: 14656957 BACKGROUND

• Vasan RS, Beiser A, Seshadri S, Larson MG, Kannel WB, D'Agostino RB, Levy D. Residual lifetime risk for developing hypertension in middle-aged women and men: The Framingham Heart Study. JAMA. 2002 Feb 27;287(8):1003-10. doi: 10.1001/jama.287.8.1003.

  PMID: 11866648 BACKGROUND

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

  PMID: 12924075 BACKGROUND

• Hajjar I, Kotchen TA. Trends in prevalence, awareness, treatment, and control of hypertension in the United States, 1988-2000. JAMA. 2003 Jul 9;290(2):199-206. doi: 10.1001/jama.290.2.199.

  PMID: 12851274 BACKGROUND

• Ong KL, Cheung BM, Man YB, Lau CP, Lam KS. Prevalence, awareness, treatment, and control of hypertension among United States adults 1999-2004. Hypertension. 2007 Jan;49(1):69-75. doi: 10.1161/01.HYP.0000252676.46043.18. Epub 2006 Dec 11.

  PMID: 17159087 BACKGROUND

• Yakovlevitch M, Black HR. Resistant hypertension in a tertiary care clinic. Arch Intern Med. 1991 Sep;151(9):1786-92.

  PMID: 1888244 BACKGROUND

• Okonofua EC, Simpson KN, Jesri A, Rehman SU, Durkalski VL, Egan BM. Therapeutic inertia is an impediment to achieving the Healthy People 2010 blood pressure control goals. Hypertension. 2006 Mar;47(3):345-51. doi: 10.1161/01.HYP.0000200702.76436.4b. Epub 2006 Jan 23.

  PMID: 16432045 BACKGROUND

• Whelton PK, He J, Appel LJ, Cutler JA, Havas S, Kotchen TA, Roccella EJ, Stout R, Vallbona C, Winston MC, Karimbakas J; National High Blood Pressure Education Program Coordinating Committee. Primary prevention of hypertension: clinical and public health advisory from The National High Blood Pressure Education Program. JAMA. 2002 Oct 16;288(15):1882-8. doi: 10.1001/jama.288.15.1882.

  PMID: 12377087 BACKGROUND

• Pickering TG, Miller NH, Ogedegbe G, Krakoff LR, Artinian NT, Goff D; American Heart Association; American Society of Hypertension; Preventive Cardiovascular Nurses Association. Call to action on use and reimbursement for home blood pressure monitoring: a joint scientific statement from the American Heart Association, American Society Of Hypertension, and Preventive Cardiovascular Nurses Association. Hypertension. 2008 Jul;52(1):10-29. doi: 10.1161/HYPERTENSIONAHA.107.189010. Epub 2008 May 22.

  PMID: 18497370 BACKGROUND

• Green BB, Cook AJ, Ralston JD, Fishman PA, Catz SL, Carlson J, Carrell D, Tyll L, Larson EB, Thompson RS. Effectiveness of home blood pressure monitoring, Web communication, and pharmacist care on hypertension control: a randomized controlled trial. JAMA. 2008 Jun 25;299(24):2857-67. doi: 10.1001/jama.299.24.2857.

  PMID: 18577730 BACKGROUND

• Keles H, Ekici A, Ekici M, Bulcun E, Altinkaya V. Effect of chronic diseases and associated psychological distress on health-related quality of life. Intern Med J. 2007 Jan;37(1):6-11. doi: 10.1111/j.1445-5994.2006.01215.x.

  PMID: 17199838 BACKGROUND

MeSH Terms

Conditions

Hypertension

Interventions

Angiotensin-Converting Enzyme Inhibitors; Receptors, Angiotensin; Calcium Channel Blockers; Renin Inhibitors; Diuretics; Vasodilator Agents

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Peptide; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Cardiovascular Agents; Therapeutic Uses; Natriuretic Agents

Study Officials

• Mohammed Rafey, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2010
• First Posted: July 22, 2010
• Study Start: November 1, 2009
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 28, 2016

Record last verified: 2016-10

Locations

US (1)