一项针对患有多种慢性病的老年人的远程监测的随机对照试验：Tele-ERA 研究。

A randomized controlled trial of telemonitoring in older adults with multiple chronic conditions: the Tele-ERA study.

机构信息

Department of Internal Medicine Mayo Clinic 200 First Street SW Rochester, Minnesota 55905, USA.

出版信息

BMC Health Serv Res. 2010 Sep 1;10:255. doi: 10.1186/1472-6963-10-255.

DOI:10.1186/1472-6963-10-255

PMID:20809953

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2939600/

Abstract

BACKGROUND

Older adults with multiple chronic illnesses are at risk for worsening functional and medical status and hospitalization. Home telemonitoring may help slow this decline. This protocol of a randomized controlled trial was designed to help determine the impact of home telemonitoring on hospitalization. The specific aim of the study reads as follows: to determine the effectiveness of home telemonitoring compared with usual care in reducing the combined outcomes of hospitalization and emergency department visits in an at-risk population 60 years of age or older.

METHODS/DESIGN: Two-hundred patients with the highest 10% Mayo Clinic Elder Risk Assessment scores will be randomly assigned to one of two interventions. Home telemonitoring involves the use of a computer device, the Intel Health Guide, which records biometric and symptom data from patients in their homes. This information is monitored by midlevel providers associated with a primary care medical practice. Under the usual care scenario, patients make appointments with their providers as problems arise and use ongoing support such as a 24-hour nurse line.Patients will have initial evaluations of gait and quality of life using instruments such as the SF-12 Health Survey, the Kokmen Short Test of Mental Status, and the PHQ-9 health questionnaire. Patients will be followed for 1 year for primary outcomes of hospitalizations and emergency department visits. Secondary analysis will include quality of life, compliance with the device, and attitudes about telemonitoring. Sample size is based on an 80% power to detect a 36% difference between the two groups. The primary analysis will involve Cox proportional time-to-event analysis. Secondary analysis will use t-test comparisons for continuous variables and the chi square test for proportional analysis.

DISCUSSION

Patients randomized to home telemonitoring will have daily assessments of their health status using the device. Registered nurse monitoring will assess any change in status followed by videoconferencing by a mid-level provider. We obtained trial registration and Institutional Review Board approval.

TRIAL REGISTRATION

Trial registration number through http://www.clinicaltrials.gov: NCT01056640.

摘要

背景

患有多种慢性病的老年人功能和医疗状况恶化以及住院的风险增加。家庭远程监护可能有助于减缓这种下降趋势。本随机对照试验方案旨在帮助确定家庭远程监护对住院的影响。该研究的具体目的如下：确定与常规护理相比，家庭远程监护在降低高危人群（60 岁或以上）的住院和急诊就诊综合结果方面的有效性。

方法/设计：将 200 名 Mayo 诊所老年风险评估得分最高的 10%的患者随机分配到两种干预措施之一。家庭远程监护涉及使用计算机设备，Intel Health Guide，该设备记录患者在家中的生物特征和症状数据。该信息由与初级保健医疗实践相关的中级提供者进行监测。在常规护理情况下，患者在出现问题时与提供者预约，并使用持续的支持，如 24 小时护士热线。患者将使用 SF-12 健康调查、Kokmen 短期精神状态测试和 PHQ-9 健康问卷等仪器进行初始步态和生活质量评估。患者将在 1 年内进行主要结局（住院和急诊就诊）随访。二次分析将包括生活质量、对设备的依从性和对远程监护的态度。样本量基于两组之间 36%差异的 80%功效进行计算。主要分析将涉及 Cox 比例风险时间事件分析。次要分析将使用 t 检验比较连续变量和卡方检验进行比例分析。