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，包括启动和保持低钠饮食，以及实施复杂的药物治疗方案。对这些行为的依从性很差，不遵守这些行为在心力衰竭医院再住院和卫生服务使用中占很大比例。 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，因此家庭方法改善自我管理行为具有很大的前景。这项研究将评估以家庭为中心的干预相对于结构化的患者-家庭教育计划和对心力衰竭患者的常规护理的增量效果。这项研究将检验增加基于自主支持理论的家庭伙伴关系干预(FPI)是否比结构化的患者家庭教育计划或常规护理更能改善饮食和服药的自我管理行为。采用随机三组重复测量设计，纳入心力衰竭患者-家庭成员二元组(n=262)。FPI干预将在门诊以小组形式提供，患者家庭教育和数据收集将在综合临床研究中心进行。患者变量和衡量标准包括膳食钠(24小时尿钠)、心力衰竭药物(包括血管紧张素转换酶抑制剂和利尿剂)的用药依从性(药物事件监测系统)、心力衰竭严重程度(脑利钠肽水平)、功能能力(6分钟步行距离)、心力衰竭患者抑郁症状(贝克抑郁问卷II)和感知生活质量(明尼苏达州心力衰竭生活问卷)。数据将在基线、4个月和8个月时获得。家庭成员变量包括在基线、4个月和8个月时获得的抑郁症状(贝克抑郁问卷-II)。次级目标将检查8个月内的卫生资源利用情况(住院、急诊科或提供者联系)以及患者和家庭成员感受到的自主支持。临床(NYHA分级、左心室射血分数、合并症)、社会人口学和一般家庭功能变量的基线测量将用于样本描述，并在假设检验中用作协变量。重复测量模型将被用来检验随着时间的推移，群体在依从性和生活质量、身体和心理结果方面的差异的假设，并控制相关的临床和社会人口学变量。这项研究将测试成本效益高的、基于理论的、护士管理的自主支持干预在改善患者和家庭结果方面是否比结构化的患者-家庭教育和常规护理提供递增的效果。这项研究将提供未来临床实践指南可以基于的数据，并将根据哪些干预措施与改善的自我管理行为联系起来，确定患者护理的优先事项。更好地了解家庭功能、自我管理行为、心理和生理结果以及卫生资源利用之间的关系，对于未来对心力衰竭患者的临床实践进行研究和评估具有重要意义。

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.