Okazaki Momoko, Suzuki Takahiro, Mizuno Atsushi, Ikegame Toshimi, Ito Noriki, Onoda Mai, Miyawaki Ikuko, Moriyama Yuka, Yabuki Taku, Yamada Satomi, Yoneoka Daisuke, Iwasawa Yuko, Tagami Kyoko, Yoshikawa Kumiko
Department of Cardiovascular Medicine, St. Luke's International Hospital, Tokyo 104-8560, Japan.
Leonard Davis Institute for Health Economics, University of Pennsylvania, Philadelphia, PA 19104, USA.
J Pers Med. 2024 Aug 6;14(8):832. doi: 10.3390/jpm14080832.
Heart Failure (HF) is a common chronic disease that has a high readmission rate and is associated with worsening symptoms and major financial impacts. Disease management implemented during or after an HF hospitalization has been shown to reduce hospitalization and mortality rates. Particularly for outpatients, it is necessary to provide self-care interventions. Structured nurse-led support such as timely follow-ups, including phone calls, is beneficial for improving self-care assessments. Evidence for nurse-led support has been investigated but is less than conclusive. The aim of this study is to compare the effectiveness of a nurse-led structured intervention for outpatients with chronic HF against the usual medical care in terms of self-care behaviors and occurrence of symptom exacerbation or rehospitalization.
This is a cluster-randomized controlled trial. A total of 40 facilities with certified HF nurses will be allocated to two-arm clusters at a 1:1 ratio, randomly to the intervention or usual care arms. A total of 210 participants will be assigned from the hospital. Participants will be adults aged 18 years or older diagnosed with chronic HF who are classified as Stage C according to the ACCF/AHA Heart Failure staging system. In the intervention group, patients will receive structured nursing support. This begins with weekly support, including phone calls, for the first month, then transitions to monthly support thereafter. The aim is to ensure the stability of their living conditions, promote medication adherence, and encourage self-management. In the control group, patients will receive the usual care. Primary outcomes will assess the improvement or continuation of self-care behavior as measured by changes in EHFScBS (European Heart Failure Self-Care Behavior Scale) scores. Secondary outcomes include occurrence of readmission within 30 days, 3 months, 6 months, and 1 year after discharge, duration of home care until readmission, and blood levels of BNP and NT-proBNP.
心力衰竭（HF）是一种常见的慢性疾病，再入院率高，与症状恶化及重大经济影响相关。在心力衰竭住院期间或之后实施疾病管理已被证明可降低住院率和死亡率。特别是对于门诊患者，提供自我护理干预很有必要。由护士主导的结构化支持，如及时随访（包括电话随访），有利于改善自我护理评估。虽然已有关于护士主导支持的证据研究，但尚无定论。本研究的目的是比较护士主导的结构化干预对慢性心力衰竭门诊患者与常规医疗护理在自我护理行为以及症状加重或再入院发生率方面的效果。
这是一项整群随机对照试验。共有40家配备有认证心力衰竭护士的机构将按1:1比例分配到两组整群中，随机分为干预组或常规护理组。将从医院招募总共210名参与者。参与者将是年龄在18岁及以上、根据美国心脏病学会基金会/美国心脏协会（ACCF/AHA）心力衰竭分期系统被归类为C期的慢性心力衰竭成年患者。在干预组中，患者将接受结构化护理支持。最初一个月每周提供支持，包括电话随访，之后过渡到每月一次。目的是确保其生活条件稳定，促进药物依从性，并鼓励自我管理。在对照组中，患者将接受常规护理。主要结局将通过欧洲心力衰竭自我护理行为量表（EHFScBS）得分变化来评估自我护理行为的改善或持续情况。次要结局包括出院后30天、3个月、6个月和1年的再入院发生率、再入院前的家庭护理时长以及脑钠肽（BNP）和N末端脑钠肽原（NT-proBNP）的血液水平。
