多组分干预措施用于急性心血管疾病的虚弱和衰弱前期老年患者：TARGET-EFT 随机临床试验。

Multicomponent intervention for frail and pre-frail older adults with acute cardiovascular conditions: The TARGET-EFT randomized clinical trial.

机构信息

Division of Experimental Medicine, McGill University, Montreal, Quebec, Canada.

Centre for Clinical Epidemiology, Jewish General Hospital, Montreal, Quebec, Canada.

出版信息

J Am Geriatr Soc. 2023 May;71(5):1406-1415. doi: 10.1111/jgs.18228. Epub 2023 Jan 16.

DOI:10.1111/jgs.18228

PMID:36645227

Abstract

BACKGROUND

Hospitalization for cardiovascular disease (CVD) may be complicated by hospital-acquired disability (HAD) and subsequently poor health-related quality of life (HRQOL). While frailty has been shown to be a risk factor, it has yet to be studied as a therapeutic target to improve outcomes.

OBJECTIVES

This trial sought to determine the effects of an in-hospital multicomponent intervention targeting physical weakness, cognitive impairment, malnutrition, and anemia on patient-centered outcomes compared to usual care.

METHODS

A single-center parallel-group randomized clinical trial was conducted in older patients with acute CVD and evidence of frailty or pre-frailty as measured by the Essential Frailty Toolset (EFT). Patients were randomized to usual care or a multicomponent intervention. Outcomes were HRQOL (EQ-5D-5L score) and disability (Older Americans Resources and Services score) at 30 days post-discharge and mood disturbances (Hospital Anxiety and Depression Scale) at discharge.

RESULTS

The trial cohort consisted of 142 patients with a mean age of 79.5 years and 55% females. The primary diagnosis was heart failure in 29%, valvular heart disease in 28%, ischemic heart disease in 14%, arrhythmia in 11%, and other CVDs in 18%. The intervention improved HRQOL scores (coefficient 0.08; 95% CI 0.01, 0.15; p = 0.03) and mood scores (coefficient -1.95; 95% CI -3.82, -0.09; p = 0.04) but not disability scores (coefficient 0.18; 95% CI -1.44, 1.81; p = 0.82). There were no intervention-related adverse events.

CONCLUSION

In frail older patients hospitalized for acute CVDs, an in-hospital multicomponent intervention targeted to frailty was safe and led to modest yet clinically meaningful improvements in HRQOL and mental well-being. The downstream impact of these effects on event-free survival and functional status remains to be evaluated in future research, as does the generalizability to other healthcare systems.

CLINICAL REGISTRATION NUMBER

NCT04291690.

摘要

背景

心血管疾病（CVD）住院可能会导致医院获得性残疾（HAD），进而导致健康相关生活质量（HRQOL）下降。虽然虚弱已被证明是一个危险因素，但尚未将其作为改善预后的治疗靶点进行研究。

目的

本试验旨在确定针对身体虚弱、认知障碍、营养不良和贫血的住院多组分干预措施与常规护理相比，对以患者为中心的结局的影响。

方法

一项单中心平行组随机临床试验在患有急性 CVD 且存在虚弱或衰弱前期的老年患者中进行，其通过基本虚弱工具包（EFT）进行测量。患者被随机分配至常规护理或多组分干预组。结局为出院后 30 天的 HRQOL（EQ-5D-5L 评分）和残疾（老年人资源和服务评分），以及出院时的情绪障碍（医院焦虑和抑郁量表）。

结果

试验队列包括 142 名平均年龄为 79.5 岁、55%为女性的患者。主要诊断为心力衰竭占 29%，瓣膜性心脏病占 28%，缺血性心脏病占 14%，心律失常占 11%，其他 CVD 占 18%。干预措施改善了 HRQOL 评分（系数 0.08；95%CI 0.01，0.15；p=0.03）和情绪评分（系数-1.95；95%CI-3.82，-0.09；p=0.04），但未改善残疾评分（系数 0.18；95%CI-1.44，1.81；p=0.82）。没有与干预相关的不良事件。