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Hypertension: Prediction of Biofeedback Success

Primary Purpose

Essential Hypertension

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Biofeedback
Sponsored by
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Essential Hypertension focused on measuring Hypertension, BIofeedback, Non-pharmacological treatment, Prediction

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

essential hypertension stages 1 or 2 not taking beta blockers or central acting alpha agonists permission from primary care provider

Sites / Locations

  • University of Florida College of Nursing

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 9, 2001
Last Updated
September 28, 2007
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00026065
Brief Title
Hypertension: Prediction of Biofeedback Success
Official Title
Hypertension: Prediction of Biofeedback Success
Study Type
Interventional

2. Study Status

Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
February 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

5. Study Description

Brief Summary
Hypertension, present in more than 50 million Americans, increases the risk of cardiovascular disease and its associated complications. More persons are turning to alternative medicine to deal with their health problems. Biofeedback may reduce blood pressure and/or allow the reduction of antihypertensive medications in some patients, while having no adverse effects. Yet biofeedback therapy is time-intensive and technician-intensive. Therefore, it is critical to be able to predict which patients with essential hypertension are most likely to lower his/her blood pressure using these techniques. This research proposes to test three different means of predicting whether a hypertensive subject will or will not be successful in lowering his/her blood pressure using biofeedback. Sixty hypertensive subjects will be studied over a three-year period. The results of this study will enable those caring for hypertensive persons to recommend biofeedback in an individualized way, thereby promoting adherence.
Detailed Description
In the next century, our health care system will attempt to manage chronic illness in the largest aging population ever known. Non-adherence to pharmacological therapy and to non-pharmacological therapy will prove very costly. Hypertension, present in more than 50 million Americans, increases the risk of cardiovascular disease and its associated morbidity and mortality. Thus is it critical that adherence to treatment of hypertension be increased. While medications are effective in certain patients, their adverse effects make compliance with treatment difficult to ensure. In addition, more and more persons are turning to alternative medicine to deal with their health problems. Biofeedback offers an alternative to medical treatment, having been shown to reduce both systolic and diastolic blood pressures and/or allow the reduction of antihypertensive medications in some patients, while having no adverse effects. Yet biofeedback therapy is time-intensive and technician-intensive. Therefore, it is critical to be able to predict which patients with essential hypertension are most likely to lower his/her blood pressure using these techniques. This research proposes to test three different means of predicting whether a hypertensive subject will or will not be successful in lowering his/her blood pressure using biofeedback. Specifically, the first set of predictive criteria to be tested is that proposed by Weaver & McGrady (1995). This model is derived from five variables: heart rate, finger temperature, forehead muscle tension, plasma rennin response to furosemide, and mean arterial pressure response to furosemide. The second prediction model is based on the magnitude of circadian variations in blood pressure as measured by 24-hour ambulatory blood pressure monitoring. The third prediction model is based on locus of control of behavior. A total of 60 hypertensive subjects will be studied over a three-year period. The results of this study will enable those caring for hypertensive persons to recommend treatment (i.e., biofeedback) in an individualized way, thereby promoting adherence.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension
Keywords
Hypertension, BIofeedback, Non-pharmacological treatment, Prediction

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Biofeedback

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
essential hypertension stages 1 or 2 not taking beta blockers or central acting alpha agonists permission from primary care provider
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolyn B Yucha, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida College of Nursing
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11469141
Citation
Yucha CB. Ambulatory blood pressure monitoring: measurement implications for research. J Nurs Meas. 2001 Spring-Summer;9(1):49-59.
Results Reference
background
PubMed Identifier
11172227
Citation
Yucha CB, Clark L, Smith M, Uris P, LaFleur B, Duval S. The effect of biofeedback in hypertension. Appl Nurs Res. 2001 Feb;14(1):29-35. doi: 10.1053/apnr.2001.21078.
Results Reference
background
PubMed Identifier
7495917
Citation
Weaver MT, McGrady A. A provisional model to predict blood pressure response to biofeedback-assisted relaxation. Biofeedback Self Regul. 1995 Sep;20(3):229-40. doi: 10.1007/BF01474515.
Results Reference
background
Links:
URL
http://www.aapb.org/
Description
Association for Applied Psychophysiology and Biofeedback

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Hypertension: Prediction of Biofeedback Success

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