Self-management behaviors required for persons with heart failure (HF) are multifaceted and include initiating and maintaining a reduced sodium diet and implementing a complex medication regimen. Adherence to these behaviors is poor, and nonadherence accounts for a large percentage of HF hospital readmissions and health services use. Because performance of these behaviors occurs in the family context and is influenced by family activities and habits, a family approach to improve self-management behaviors has great promise. This study will evaluate the incremental effect of a family-focused intervention over a structured patient-family education program and usual care for persons with heart failure. The study will examine whether adding a family partnership intervention (FPI) based on autonomy support theory improves dietary and medication-taking self-management behaviors over a structured patient family education program or usual care. A randomized three group repeated measures design will be used to enroll HF patient-family member dyads (n=262). The FPI Intervention will be delivered in the outpatient setting in a group format, and patient-family education and data collection will occur in the General Clinical Research Center. Patient variables and measures are dietary sodium (24-hour urinary sodium), medication adherence to HF drugs including angiotensin converting enzyme inhibitors and diuretics (Medication Event Monitoring System), heart failure severity (brain natriuretic peptide levels), functional ability (6 minute walk distance), HF patient depressive symptoms (Beck Depression Inventory II), and perceived quality of life (Minnesota Living with Heart Failure Questionnaire). Data will be obtained at baseline, and 4 and 8 months. Family member variables include depressive symptoms (Beck Depression Inventory-II) obtained at baseline, 4 and 8 months. Secondary aims will examine health resource utilization (hospitalizations, emergency department or provider contacts) over the 8 months and patient and family member perceived autonomy support. Baseline measures of clinical (NYHA Class, left ventricular ejection fraction, comorbidities), sociodemographic, and general family functioning variables will be obtained for sample description and use as covariates in hypothesis testing. Repeated measures models will be used to test the hypotheses of group differences in adherence and quality of life, physical and psychological outcomes over time controlling for pertinent clinical and sociodemographic variables. This study will test whether a cost-effective, theoretically-based, nurse managed autonomy support intervention provides an incremental effect over structured patient-family teaching and usual care in improving patient and family outcomes. This study will provide data upon which future clinical practice guidelines can be based and will establish priorities for patient care according to which interventions are linked to improved self-management behaviors. Greater understanding of the relationships among family functioning, self management behaviors, psychological and physical outcomes, and health resource utilization are important for future studies and evaluation of clinical practice with HF patients.
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