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Biobehavioral Intervention in Heart Failure
Debra Moser, D.N.Sc.,
Principal Investigator;
Ann Peden, D.S.N.,
Mary Kay Rayens, Ph.D.,
Thomas Whayne, Jr., M.D., Ph.D.,Co-investigators
Funded by the National
Institutes of Health/National Institute of Nursing
Research
Grant #R01 NR00856701A1
(2004-2009)
Abstract
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Heart failure has been called the most important public
health problem facing cardiovascular clinicians and
researchers because of its high and increasing incidence,
prevalence, morbidity and mortality. Despite substantial
advances in pharmacologic therapy in recent years, clinical
improvements among patients are relatively modest and
quality of life often remains poor. Nonpharmacologic therapy
has received relatively little attention, yet is potentially
an important adjunct to pharmacologic therapy.
Biofeedback-relaxation, a cognitive biobehavioral
nonpharmacologic intervention, has been demonstrated to be
effective in conditions with pathophysiology similar to that
seen in heart failure and could address the adverse
physiological and psychological manifestations of heart
failure.
Accordingly, specific aims of this project are to
determine the impact of biofeedback-relaxation training on
- the combined primary end-point of heart failure rehospitalizations or cardiac mortality
- quality of life
- intermediate (mediating) outcomes of functional
status, magnitude of heart failure symptoms, perceived
control, and dysphoria
- intermediate (mediating) physiologic outcomes of
finger and foot skin temperature, heart rate variability
and plasma norepinephrine.
We hypothesize that biofeedback-relaxation training will
result in significant decreases in heart failure
rehospitalizations or cardiac death, improved quality of
life, increased functional capacity, decreased symptoms,
increased perceived control, decreased anxiety and
depression, increased finger and foot temperature, improved
heart rate variability, and decreased plasma norepinephrine.
To test these hypotheses, 280 patients with advanced
heart failure will be randomized to one of two groups:
- biofeedback-relaxation
- sham biofeedback-relaxation.
Data will be collected at baseline, three months, and 12
months and will be analyzed using survival analyses and
repeated measure ANOVA. Biofeedback-relaxation training for
patients with heart failure may have potential long-term
clinical benefits and may serve as an important adjunct to
pharmacologic therapy.
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