Basso Ines, Bassi Erika, Caristia Silvia, Durante Angela, Vairo Cristian, Patti Salvatore Giuseppe Rocco, Pirisi Mario, Campanini Mauro, Invernizzi Marco, Bellan Mattia, Dal Molin Alberto
University of Piemonte Orientale Amedeo Avogadro, Novara, Italy.
University Hospital Maggiore della Carità, Novara, Italy.
MethodsX. 2024 Jun 30;13:102832. doi: 10.1016/j.mex.2024.102832. eCollection 2024 Dec.
Poor treatment adherence and lack of self-care behaviors are significant contributors to hospital readmissions of people with heart failure (HF). A transitional program with non-invasive telemonitoring may help sustain patients and their caregivers to timely recognize signs and symptoms of exacerbation. We will conduct a Randomized Clinical Trial (RCT) to evaluate the feasibility and acceptability of a 6-month supportive intervention for patients discharged home after cardiac decompensation. Forty-five people aged 65 years and over will be randomized to either receive a supportive intervention in addition to standard care, which combines nurse-led telephone coaching and a home-based self-monitoring vital signs program, or standard care alone. Four aspects of the feasibility will be assessed using a mixed-methods approach: process outcomes (e.g., recruitment rate), resources required (e.g., adherence to the intervention), management data (e.g., completeness of data collection), and scientific value (e.g. 90- and 180-day all-cause and HF-related readmissions, self-care capacity, quality of life, psychological well-being, mortality, etc.). Participants will be interviewed to explore preferences and satisfaction with the intervention. The study is expected to provide valuable insight into the design of a definitive RCT.
治疗依从性差和缺乏自我护理行为是导致心力衰竭（HF）患者再次入院的重要因素。一项采用非侵入性远程监测的过渡项目可能有助于患者及其护理人员及时识别病情加重的迹象和症状。我们将进行一项随机临床试验（RCT），以评估对失代偿性心力衰竭后出院回家的患者进行为期6个月的支持性干预的可行性和可接受性。45名65岁及以上的患者将被随机分组，一组除接受标准护理外，还接受支持性干预，该干预结合了护士主导的电话指导和家庭自我监测生命体征项目；另一组仅接受标准护理。将采用混合方法评估可行性的四个方面：过程结果（如招募率）、所需资源（如干预的依从性）、管理数据（如数据收集的完整性）和科学价值（如90天和180天的全因再入院率和与心力衰竭相关的再入院率、自我护理能力、生活质量、心理健康、死亡率等）。将对参与者进行访谈，以探讨他们对干预措施的偏好和满意度。该研究有望为确定性RCT的设计提供有价值的见解。
