1 Faculty of Medicine and Life Sciences, Hasselt University, Belgium.
2 Department of Cardiology, Jessa Hospital, Belgium.
J Telemed Telecare. 2019 Jun;25(5):286-293. doi: 10.1177/1357633X18774632. Epub 2018 May 10.
The TElemonitoring in the MAnagement of Heart Failure (TEMA-HF) 1 long-term follow-up study assessed whether an initial six-month telemonitoring (TM) programme compared with usual care (UC) would result in reduced all-cause mortality, heart failure admissions and healthcare costs in chronic heart failure (CHF) patients at long-term follow-up.
Of the 160 patients included in the multi-centre, randomised controlled telemonitoring trial (TEMA-HF 1, time point t); 142 CHF patients (65% male; age: 76 ± 10 years; EF: 36 ± 15%) were alive and entered the follow-up study (time point: t) with a final evaluation at 79 months (time point: t). Both TM and UC group patients received standard heart failure care during the follow-up study (time points: t - t). The primary endpoint was all-cause mortality. Secondary outcomes included days lost due to heart failure readmissions and readmission/patient follow-up related healthcare costs.
Compared with usual care, the initial six-month TM programme had no significant effect on all-cause mortality (hazard ratio: 0.83; 95% confidence interval, 0.57 to 1.20; p = 0.32). The number of days lost due to heart failure readmissions was significantly lower in the TM group ( p = 0.04). Healthcare costs did not differ significantly between the TM (€ 9140 ± 10580) and UC group (€ 12495 ± 22433) ( p = 0.87).
An initial six-month telemonitoring programme was not associated with reduced all-cause mortality in CHF patients at long-term follow-up but resulted in a reduction in the number of days lost due to heart failure readmissions. This study is registered in the ClinicalTrials.gov registry (NCT03171038) (URL: https://clinicaltrials.gov/ct2/show/NCT03171038 ).
TElemonitoring 在心力衰竭管理中的 1 项长期随访研究评估了初始 6 个月的远程监测 (TM) 方案与常规护理 (UC) 相比是否会降低心力衰竭患者在长期随访时的全因死亡率、心力衰竭再入院率和医疗保健成本。
在多中心、随机对照的远程监测试验 (TEMA-HF 1,时间点 t) 中纳入的 160 例患者中;142 例心力衰竭患者(65%为男性;年龄:76 ± 10 岁;EF:36 ± 15%)存活并进入随访研究(时间点:t),最终评估时间为 79 个月(时间点:t)。在随访研究期间(时间点:t-t),TM 和 UC 组患者均接受标准心力衰竭治疗。主要终点是全因死亡率。次要结局包括因心力衰竭再入院而损失的天数和再入院/患者随访相关的医疗保健成本。
与常规护理相比,初始 6 个月的 TM 方案对全因死亡率没有显著影响(风险比:0.83;95%置信区间,0.57 至 1.20;p=0.32)。TM 组因心力衰竭再入院而损失的天数明显减少(p=0.04)。TM 组(€9140±10580)和 UC 组(€12495±22433)的医疗保健成本无显著差异(p=0.87)。
初始 6 个月的远程监测方案与心力衰竭患者的长期随访时的全因死亡率降低无关,但可减少因心力衰竭再入院而损失的天数。本研究在 ClinicalTrials.gov 注册(NCT03171038)(网址:https://clinicaltrials.gov/ct2/show/NCT03171038)。