Hypertension: Prediction of Biofeedback Success
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): Biofeedback
Intervention type(s): Behavioral
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Hypertension; BIofeedback; Non-pharmacological treatment; Prediction