A Family Partnership Intervention for Heart Failure

描述（由申请人提供）：心力衰竭（HF）患者所需的自我管理行为是多方面的，包括开始和维持低钠饮食以及实施复杂的药物治疗方案。坚持这些行为是穷人，和不遵守占很大比例的HF医院再入院和卫生服务的使用。 由于这些行为的表现发生在家庭环境中，并受到家庭活动和习惯的影响，因此家庭方法可以改善自我管理行为。本研究将评估以家庭为中心的干预措施相对于结构化患者家庭教育计划和常规护理对心力衰竭患者的增量效应。这项研究将研究是否增加了基于自主支持理论的家庭伙伴关系干预（FPI）改善饮食和服药自我管理行为，而不是结构化的患者家庭教育计划或常规护理。将采用随机化三组重复测量设计入组HF患者-家庭成员二元组（n=262）。FPI干预将在门诊以小组形式进行，患者家庭教育和数据收集将在综合临床研究中心进行。患者变量和措施是膳食钠（24小时尿钠），HF药物（包括血管紧张素转换酶抑制剂和利尿剂）的药物依从性（用药事件监测系统），心力衰竭严重程度（脑钠肽水平），功能能力（6分钟步行距离），HF患者抑郁症状（贝克抑郁量表II）和感知生活质量（明尼苏达心力衰竭生活问卷）。将在基线、4个月和8个月时获得数据。家庭成员变量包括基线、4个月和8个月时获得的抑郁症状（贝克抑郁量表-II）。次要目标将检查8个月内的卫生资源利用（住院、急诊科或提供者联系）以及患者和家庭成员感知的自主支持。将获得临床（NYHA分级、左心室射血分数、合并症）、社会人口统计学和一般家庭功能变量的基线测量值，用于样本描述并用作假设检验的协变量。将使用重复测量模型检验依从性和生活质量、随时间推移的身体和心理结局的组间差异假设，控制相关临床和社会人口统计学变量。本研究将测试是否具有成本效益，理论为基础的，护士管理的自主权支持干预提供了一个渐进的影响，结构化的病人家庭教学和日常护理，改善病人和家庭的结果。这项研究将提供数据，未来的临床实践指南可以基于这些数据，并将根据哪些干预措施与改善自我管理行为有关，确定患者护理的优先事项。更好地理解家庭功能、自我管理行为、心理和身体结果以及卫生资源利用之间的关系对于未来的研究和评估HF患者的临床实践非常重要。

DESCRIPTION (provided by applicant): 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.