一项针对晚期心肺疾病患者家庭远程监测的随机临床试验。

A randomized clinical trial of home telemonitoring in patients with advanced heart and lung diseases.

机构信息

Internal Medicine Department, Complejo Hospitalario Virgen del Rocío, Seville, Spain.

Internal Medicine Department, Hospital Universitario Virgen de Valme, Seville, Spain.

出版信息

J Telemed Telecare. 2024 Feb;30(2):356-364. doi: 10.1177/1357633X211059707. Epub 2021 Dec 1.

DOI:10.1177/1357633X211059707

PMID:34851202

Abstract

BRIEF SUMMARY

The addition of home monitoring to an integrated care model in patients with advanced chronic heart/lung diseases decreases mortality, hospital and emergency admissions, improves functional status, HRQoL, and is cost-effective.

BACKGROUND

Telemonitoring is a promising implement for medicine, but its efficacy is unknown in patients with advanced heart and lung failure (AHLF).

OBJECTIVE

To determine the efficacy of a telemonitoring system added to coordinated clinical care in patients with AHLF.

DESIGN

Randomized phase 3 multicenter clinical trial with parallel groups in adult patients.

PARTICIPANTS

Five spanish centers including patients with AHLF at discharge or in out-patient clinics.

INTERVENTION

Patients were randomly assigned to receive a remote bio-parameters telemonitoring system (TELECARE) or best usual care (UCARE). TELECARE patients were provided with devices that collected symptoms and bio-parameters, and transferred them synchronously to a call-center, with a real-time health-care response.

MAIN MEASURES

Primary end point was the need of admissions/emergency room visits at 45, 90, 180 days. Secondary end points included health care requirements, mortality, functional assessment, health related quality of life (HRQoL), perceived satisfaction, and cost-efficacy.

RESULTS

510 patients were included (54.5% women, median age 76.5 years; 63.1% suffered heart failure, 13.9% lung failure, and 22.9% both conditions). Clinical and functional features were comparable in both arms. TELECARE globally needed less admissions with respect UCARE after 45 days of inclusion (35.4% vs. 46.9%, < 0.05). This tendency was maintained in the subgroups of patients with multimorbidity (34.2% vs. 46.9%, < 0.05), intermediate risk of mortality (36.5% vs. 51.1%, < 0.05), and those included after hospital discharge (34.9% vs. 50.5%, < 0.01). HRQoL significantly improved (TELECARE/UCARE EuroQol baseline of 56.2 ± 18.2/55.1 ± 19.7, = 0.054, and 64 ± 19.9/56.3 ± 21.6; < 0.01 at the end), and perceived satisfaction was also higher (6.77 ± 0.52 vs. 6.62 ± 0.81, < 0.001; highest possible score = 7). A trend to mortality decrease was also observed (12.9% vs. 19.3%, = 0.13). TELECARE was cost-efficacious (TELECARE/UCARE QALY 3.94 Euros/0.81Euros).

CONCLUSIONS

The addition of a telemonitoring system to an integrated care model in patients with AHLF decreases hospital and emergency admissions, improves functional status as well as HRQoL, and is cost-efficacious.

摘要

简要总结

在患有晚期慢性心肺疾病的患者中，将家庭监测加入综合护理模式可降低死亡率、住院和急诊入院率，改善功能状态、HRQoL，并具有成本效益。

背景

远程监测是医学的一项有前途的实施手段，但在有晚期心肺衰竭（AHLF）的患者中，其疗效尚不清楚。

目的

确定远程监测系统在 AHLF 患者中的综合护理模式中的疗效。

设计

随机 3 期多中心临床试验，平行组，纳入成年患者。

参与者

包括 5 个西班牙中心的 AHLF 出院或门诊患者。

干预措施

患者被随机分配接受远程生物参数远程监测系统（TELECARE）或最佳常规护理（UCARE）。TELECARE 患者配备了可收集症状和生物参数的设备，并将其同步传输到呼叫中心，提供实时医疗保健响应。

主要措施

主要终点是在 45、90、180 天需要入院/急诊就诊的情况。次要终点包括医疗保健需求、死亡率、功能评估、健康相关生活质量（HRQoL）、感知满意度和成本效益。

结果

共纳入 510 例患者（54.5%女性，中位年龄 76.5 岁；63.1%患有心力衰竭，13.9%患有肺衰竭，22.9%同时患有两种疾病）。两组患者的临床和功能特征均相似。与 UCARE 相比，TELECARE 在纳入后 45 天内的住院和急诊就诊需求总体减少（35.4%比 46.9%，<0.05）。在合并多种疾病（34.2%比 46.9%，<0.05）、中危死亡率（36.5%比 51.1%，<0.05）和出院后纳入的亚组中，这种趋势持续存在（34.9%比 50.5%，<0.01）。HRQoL 显著改善（TELECARE/UCARE EuroQol 基线为 56.2±18.2/55.1±19.7，=0.054，64±19.9/56.3±21.6；<0.01），感知满意度也更高（6.77±0.52 比 6.62±0.81，<0.001；最高可能分数=7）。死亡率也呈下降趋势（12.9%比 19.3%，=0.13）。TELECARE 具有成本效益（TELECARE/UCARE QALY 3.94 欧元/0.81 欧元）。