Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00026065
Status:
COMPLETED
Last Update Posted:
2007-10-01
First Post:
2001-11-09
Brief Title:
Hypertension Prediction of Biofeedback Success
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Hypertension Prediction of Biofeedback Success
Status:
COMPLETED
Status Verified Date:
2006-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 hisher 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 hisher 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 andor 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 hisher 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 hisher 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 ie biofeedback in an individualized way thereby promoting adherence
This research proposes to test three different means of predicting whether a hypertensive subject will or will not be successful in lowering hisher 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 ie biofeedback in an individualized way thereby promoting adherence
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None