Patients with heart failure experience high hospitalization. However, patients cannot recognize symptoms according to current approaches, which needs to be improved by new self-monitoring instruments and strategies. Thus, we aimed to assess a self-monitoring traffic light diary on outcomes of patients with heart failure. This was a single-blind, two-arm parallel group randomized controlled trial at the heart failure clinic of Tehran Heart Center (Tehran, Iran). Adult patients with a definitive diagnosis of heart failure with reduced ejection fraction (i.e., ejection fraction of less than 40 %), and New York Heart Association functional classes II–IV were included. A block-balanced randomization method was used to assign eligible subjects to the intervention or control group. Baseline data were collected before random allocation. Participants in the intervention group received a comprehensive intervention consisting of (1) self-care education by an Australian Heart Foundation booklet on heart failure, (2) regular self-monitoring of weight and shortness of breath at home, and (3) scheduled call follow-ups for three months. Patients in the control group received usual care. The primary outcome was heart failure self-care; the secondary outcomes were heart failure quality of life, knowledge, and all-cause hospitalization. From June to August 2017, 68 patients were included in the study. The overall age of participants was 55 (13.6) years old, and 71 % of patients were male. A significant association between the intervention and self-care maintenance (β 5.1; 95 % CI 2.50 to 7.70, < 0.001), self-care management (β 10.6; 95 % CI 6.50 to 14.8, < 0.001), self-care confidence (β 8.0; 95 % CI 5.0 to 11.0, < 0.001) and heart failure knowledge (β 1.7; 95 % CI 1.30, 2.04; < 0.001) was found. However, there was no association between the intervention and quality of life (β 2.5; 95 % CI −0.79, 5.88, 0.135) and hospitalization-free survival of the two groups (Log-Rank 0.540). A self-monitoring traffic light diary can improve self-care behaviors and heart failure knowledge in patients with heart failure with reduced ejection fraction. Iranian Registry of Clinical Trials IRCT2017021032476N1. PMCID: PMC6262204.

中文翻译：

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自我监测交通灯日记对心力衰竭患者预后的功效：一项随机对照试验

心力衰竭患者的住院率很高。然而，患者无法根据目前的方法识别症状，需要通过新的自我监测仪器和策略来改进。因此，我们的目的是评估自我监测交通灯日记对心力衰竭患者预后的影响。这是在德黑兰心脏中心（伊朗德黑兰）心力衰竭诊所进行的一项单盲、双臂平行组随机对照试验。明确诊断为心力衰竭、射血分数降低（即射血分数低于 40%）且纽约心脏协会功能分级为 II-IV 级的成年患者被纳入研究。使用块平衡随机化方法将符合条件的受试者分配到干预组或对照组。在随机分配之前收集基线数据。干预组的参与者接受了综合干预，包括 (1) 澳大利亚心脏基金会关于心力衰竭的小册子的自我护理教育，(2) 在家定期自我监测体重和呼吸急促，以及 (3) 预约通话随访三个月。对照组患者接受常规护理。主要结局是心力衰竭的自我护理；次要结局是心力衰竭的生活质量、知识和全因住院治疗。2017年6月至8月，该研究纳入了68名患者。参与者的总体年龄为 55 (13.6) 岁，其中 71% 的患者为男性。干预与自我护理维持（β 5.1；95 % CI 2.50 至 7.70，< 0.001）、自我护理管理（β 10.6；95 % CI 6.50 至 14.8，< 0.001）、自我护理信心（ β 8.0；95 % CI 5.0 至 11.0，< 0.001）和心力衰竭知识（β 1.7；95 % CI 1.30，2.04；< 0.001）被发现。然而，干预措施与两组的生活质量（β 2.5；95% CI -0.79, 5.88, 0.135）和无住院生存率（Log-Rank 0.540）之间没有关联。自我监控红绿灯日记可以改善射血分数降低的心力衰竭患者的自我护理行为和心力衰竭知识。伊朗临床试验注册中心 IRCT2017021032476N1。PMCID：PMC6262204。