慢性心衰患者的远程疾病管理计划有效性评价：一项非劣效性随机对照试验

段永杰; 钟琴; 饶宠佑; 李宗任; 付立强; 汪驰; 朱頔; 王瑞青; 董蔚; 何昆仑

doi:10.12435/j.issn.2095-5227.2023.118

慢性心衰患者的远程疾病管理计划有效性评价：一项非劣效性随机对照试验

Effectiveness of telemonitoring-based disease management program in patients with chronic heart failure: a non-inferiority randomized controlled trial

摘要

摘要:
背景新冠肺炎疫情中，心力衰竭患者门诊复查受阻，而针对心衰患者运用体外远程监护设备进行疾病管理的有效性尚无定论。
目的探究远程监护疾病管理计划是否非劣效于传统门诊复查。
方法本研究为随机对照研究，采取非劣效性设计，招募在解放军总医院第一医学中心住院治疗的心衰患者，随机分配至远程监护组(远程组)或门诊复查组(门诊组)。干预持续6个月，在第三月和第六月进行随访收集患者数据。门诊组接受常规门诊复查干预。远程组在降低门诊复查频率的同时接受远程监护管理。本研究主要结局指标是因心血管意外住院或全因死亡损失天数百分比。次要结局指标是患者NT-proBNP、生活质量(MLHFQ评分)以及患者依从性。
结果本研究招募113名患者(远程组57例，门诊组56例)，97人完成随访。干预后3个月、6个月，远程组与门诊组受试者因心血管意外住院或全因死亡损失天数百分比在非劣性检验中有显著差异(非劣效性检验P＜0.05)。两组MLHFQ评分均较基线期下降，且远程组评分明显低于门诊组(P＜0.05)。两组平均NT-proBNP均较基线期显著下降(P＜0.05)，远程组下降幅度明显高于门诊组(P=0.022)。在远程组中，远程监护系统使用率为76.92%。门诊组中，48名患者(85.71%)按要求完成了门诊复查。
结论本研究中对心衰患者实施的远程监护疾病管理计划在降低因心血管意外住院或全因死亡损失天数百分比的效果上不劣于传统门诊复查。同时明显改善了患者的NT-proBNP以及生活质量水平。

Abstract:
Background Outpatient review of patients with heart failure (HF) is impeded in contexts of the COVID-19 pandemic, and the effectiveness of using telemonitoring devices for disease management in patients with HF is inconclusive.
Objective To investigate whether a telemonitoring-based disease management program is noninferior to traditional outpatient review.
Methods Adopting a non-inferiority design, this study recruited patients with HF at the First Medical Center of Chinese PLA General Hospital and randomly assigned them to the telemonitoring management group (TMG) and outpatient review group (ORG). The trial intervention lasted for six months, with follow-up visits in the third and sixth months to collect patients’ data. The ORG received the routine outpatient review intervention. The TMG received telemonitoring management while reducing the frequency of outpatient reviews. The primary outcome in this study was the percentage of days lost due to unplanned cardiovascular hospital admissions or all-cause death. Secondary outcomes were patients’ NT-proBNP, quality of life, and patient adherence.
Results Totally 113 patients were recruited (57 in the TMG and 56 in the ORG), with 97 cases had completed the six-month follow-up. The percentage of days lost due to unplanned cardiovascular hospital admission or all-cause death was significantly different between subjects in the TMG and ORG review groups at 3- and 6-month post-intervention in the non-inferiority test (P< 0.05 for non-inferiority test). MLHFQ scores decreased from the baseline period in both test groups, and a comparison between the two groups found that scores in the TMG were significantly lower than those in the ORG (P＜0.05). The mean NT-proBNP level decreased significantly in both groups compared to the baseline period (P<0.05), and the decrease in the TMG was significantly higher than that in the ORG (P=0.022). In the TMG, the utilization rate of the telemonitoring system was 76.92%. In the ORG, 48 (85.71%) subjects completed the outpatient review as required.
Conclusion The telemonitoring-based disease management program implemented for heart failure patients in this study is noninferior to traditional outpatient review in reducing the percentage of days lost due to unplanned cardiovascular hospital admission or all-cause death, which significantly reduces NT-proBNP as well as improves quality of life levels in HF patients.

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