| |
The purpose of this randomized, controlled study is to
test the effects of a theory-based intervention designed to
improve dietary sodium restriction self-management in
chronic heart failure (HF) patients. A secondary purpose is
to test the impact of the intervention on patient attitudes,
subjective norm and perceived behavioral control (constructs
of the Theory of Planned Behavior [TPB]). Heart failure is
the most rapidly growing cardiovascular disorder in the
United States and the leading cause of hospital admissions
for Medicare patients. The most common proximate cause of HF
hospitalizations is volume overload, in most cases,
attributed to failure to self-manage a low sodium diet.
Explicit teaching regarding dietary sodium restriction is
essential to adherence in those with chronic HF. No studies
have been performed isolating the effect of a theory based
intervention on adherence to the recommended 2 gram sodium
diet in HF patients.
The specific aims of this study are to test the impact of
a theory-based self-management intervention designed to
improve adherence to the low sodium diet on: 1)
hospitalization and time alive out of hospital; 2) adherence
to a low sodium diet; 3) quality of life; 4) indicators of
the constructs of the Theory of Planned Behavior; 5)
symptoms; 6) B-type natriuretic peptide (BNP) levels, and,
7) heart rate variability (HRV).
Fifty patients with chronic HF will be recruited into
this pilot study and randomly assigned to either a control
or intervention group. Inclusion criteria are: (1) a
confirmed diagnosis of HF due to left ventricular systolic
dysfunction or with preserved systolic function; (2) NYHA
Class II - IV; (3) no cognitive impairments limiting the
ability to complete an interview; (4) residence outside of
an extended care facility and within 60 miles of the
University of Kentucky; (5) 21 years of age or older; 6)
hospitalization for HF treatment 6 months prior to study
entry, and, 7) English speaking. Data will be collected at
baseline, 6 weeks and at 6 months. The control group will
receive usual care; the intervention group will receive a
low-sodium diet self-management intervention that focuses on
providing knowledge and other tools for dietary
self-management. The intervention will include instruction
on dietary sodium restriction tailored to meet patient
learning needs, overcome individual barriers to adherence,
and involve significant others. The log-rank test will be
used to compare time to heart failure hospitalization
between the intervention and control groups. Cox
proportional hazards regression also will be used to assess
predictor of this endpoint. Kaplan-Meier plots will be used
to graphically depict group differences in readmission-free
survival. Repeated measures analysis of variance (ANOVA)
will be used to compare the two groups on adherence, quality
of life, indicators of the constructs of the TPB, symptoms,
BNP, and HRV.
Results from this study will demonstrate the potential of
a focused, single component intervention to improve outcomes
in patients with HF. In addition, this study will provide
essential pilot data for a planned R01 submission in 2010.
|
|
Top |
