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德国初级保健中针对病毒感染后症状综合征的以患者为中心的跨专业远程会诊——集群随机对照COVI-Care M-V试验方案

Patient-centred interprofessional teleconsultation for post-viral symptom complexes in German primary care-protocol for the cluster-randomised controlled COVI-Care M-V trial.

作者信息

Löffler Christin, Daubmann Anne, Endlicher Daniela, Galchenko Viacheslav, Jendyk Ralf, Reisinger Emil Christian, Sombetzki Martina, Ozga Ann-Kathrin, Wollny Anja, Feldmeier Gregor

机构信息

Institute of General Practice, Rostock University Medical Center, Doberaner Str. 142, Rostock, 18057, Germany.

Institute for Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Martinistraße 52, Hamburg, 20246, Germany.

出版信息

BMC Health Serv Res. 2025 Sep 9;25(1):1194. doi: 10.1186/s12913-025-13276-6.

Abstract

BACKGROUND

Post-viral syndromes, including long- and post-COVID, often lead to persistent symptoms such as fatigue and dyspnoea, affecting patients' daily lives and ability to work. The COVI-Care M-V trial examines whether interprofessional, patient-centred teleconsultations, initiated by general practitioners in cooperation with specialists, can help reduce symptom burden and improve care for patients.

METHODS

To evaluate the effectiveness of the intervention under routine care conditions, a cluster-randomised controlled trial is being conducted. The primary outcome is physical performance, assessed by the difference between the actual and individually defined target distance in the 6-min walk test. Secondary outcomes include health-related quality of life (PAC-19QoL), cognitive function (DemTect), lung function (peak flow meter), fatigue symptoms (FAS), and weekly working hours, measured at baseline (T0) and after four months (T1).

RESULTS

In the absence of evidence-based therapies for post-viral symptom complexes, multidisciplinary care and support currently represent the mainstay of patient management. The COVI-Care M-V study evaluates a regionally tailored, patient-centred intervention, developed based on qualitative research and piloting. Anticipated challenges include selection bias, recruitment difficulties due to healthcare staff shortages, and underreporting of symptoms, which will be addressed through targeted awareness materials and digital support for participating practices.

CONCLUSIONS

This study aims to generate evidence to enhance care, particularly by optimising healthcare structures for affected individuals.

TRIAL REGISTRATION

ISRCTN, ISRCTN11050086 . Registered 28 April 2025.

摘要

背景

包括长期新冠和新冠后综合征在内的病毒感染后综合征,常常导致疲劳和呼吸困难等持续症状,影响患者的日常生活和工作能力。COVI-Care M-V试验旨在研究由全科医生与专科医生合作发起的跨专业、以患者为中心的远程会诊,是否有助于减轻症状负担并改善患者护理。

方法

为评估常规护理条件下该干预措施的有效性,正在进行一项整群随机对照试验。主要结局是身体机能,通过6分钟步行试验中实际行走距离与个体定义的目标距离之差来评估。次要结局包括健康相关生活质量(PAC-19QoL)、认知功能(DemTect)、肺功能(峰值流量计)、疲劳症状(FAS)以及每周工作时长,在基线期(T0)和四个月后(T1)进行测量。

结果

在缺乏针对病毒感染后症状复合体的循证疗法的情况下,多学科护理和支持目前是患者管理的主要手段。COVI-Care M-V研究评估了一项基于定性研究和试点开发的、针对特定区域且以患者为中心的干预措施。预期挑战包括选择偏倚、因医护人员短缺导致的招募困难以及症状报告不足,将通过有针对性的宣传材料和为参与实践提供数字支持来解决这些问题。

结论

本研究旨在生成证据以加强护理,特别是通过优化针对受影响个体的医疗结构。

试验注册

ISRCTN,ISRCTN11050086。于2025年4月28日注册。

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