Department of Rehabilitation Medicine, Care and Public Health Research Institute, Maastricht University, Maastricht, Netherlands.
Adelante Centre of Expertise in Rehabilitation and Audiology, Hoensbroek, Netherlands.
JMIR Res Protoc. 2024 Oct 11;13:e63951. doi: 10.2196/63951.
Patients with post-COVID-19 condition (PCC) experience a wide range of complaints (physical, cognitive, and mental), sometimes with high levels of disability in daily activities. Evidence of effective interdisciplinary rehabilitation treatment is lacking. A person-centered, biopsychosocial, interdisciplinary rehabilitation program, adapted to expert opinions and the patient's needs, was therefore developed.
This study aims to present a study protocol for a clinical trial to evaluate the effect of a new, person-centered, interdisciplinary rehabilitation treatment for PCC. It is aimed at improving participation in society and health-related quality of life in patients with PCC who perceive a high level of disability in daily activities or participation.
A total of 20 Dutch adults, aged 18 years or older, with high levels of disability in daily activities and participation in society will be included in this replicated and randomized single-case experimental design study, from October 2023 onward. The replicated and randomized single-case experimental design consists of 3 phases. The baseline phase is the observational period, in which no specific treatment will be given. In the intervention phase, patients will receive the new outpatient treatment 3 times a week for 12 weeks, followed by a 12-week follow-up phase. During the intervention phase, the treatment will be personalized according to the patient's physical, mental, and cognitive symptoms and goals. The treatment team can consist of a rehabilitation physician, physiotherapist, occupational therapist, speech therapist, and psychologist. The primary outcomes of the study are daily diaries, which consist of 8 questions selected from validated questionnaires (Utrecht Scale for Evaluation of Rehabilitation-Participation, EQ-5D-5L, and the Hospital Anxiety and Depression Scale). The other primary outcome measurements are participation in society (Utrecht Scale for Evaluation of Rehabilitation-Participation) and health-related quality of life (EQ-5D-5L). The secondary outcomes are physical tests and validated questionnaires aimed at physical, mental, and cognitive complaints. Effect evaluation based on daily assessments will include visual analysis, calculation of effect sizes (Nonoverlap of All Pairs), randomization tests, and multilevel analysis. In addition, other analyses will be based on ANOVA or a 2-tailed Student t test.
Data collection for this study started in October 2023 and is planned to be completed in July 2024. The results will be published in peer-reviewed journals and presented at international conferences.
This is the first study investigating the effect of an interdisciplinary rehabilitation treatment with a person-centered, biopsychosocial approach in patients with PCC. Our findings will help to improve the treatment and support of patients with PCC.
German Clinical Trials Register DRKS00032636; https://drks.de/search/en/trial/DRKS00032636.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/63951.
新冠后疾病（PCC）患者会出现多种症状（身体、认知和精神），有时日常生活活动的残疾程度较高。目前缺乏有效的跨学科康复治疗证据。因此，我们制定了一种以患者为中心、生物心理社会跨学科的康复治疗方案，该方案根据专家意见和患者需求进行了调整。
本研究旨在介绍一项临床试验的研究方案，以评估一种新的、以患者为中心的跨学科康复治疗方法对 PCC 的疗效。该方法旨在提高 PCC 患者的社会参与度和健康相关生活质量，这些患者认为自己在日常生活活动或参与方面存在高度残疾。
从 2023 年 10 月开始，将纳入 20 名荷兰成年人，年龄在 18 岁及以上，日常生活活动和社会参与方面存在高度残疾，将其纳入本复制随机单病例实验设计研究。复制随机单病例实验设计包括 3 个阶段。基线阶段是观察期，在此期间不会给予特定的治疗。在干预阶段，患者将每周接受 3 次新的门诊治疗，持续 12 周，然后进行 12 周的随访阶段。在干预阶段，根据患者的身体、心理和认知症状和目标，个性化治疗。治疗团队可以由康复医生、物理治疗师、职业治疗师、言语治疗师和心理学家组成。研究的主要结果是 8 个从经过验证的问卷中选择的日常日记问题（乌得勒支康复评估参与量表、EQ-5D-5L 和医院焦虑和抑郁量表）。其他主要的测量结果是社会参与度（乌得勒支康复评估参与量表）和健康相关生活质量（EQ-5D-5L）。次要结果是身体测试和针对身体、心理和认知问题的经过验证的问卷。基于日常评估的效果评估将包括视觉分析、效果大小的计算（所有对的非重叠）、随机化检验和多水平分析。此外，还将基于 ANOVA 或双侧学生 t 检验进行其他分析。
本研究的数据收集于 2023 年 10 月开始，计划于 2024 年 7 月完成。研究结果将发表在同行评议的期刊上，并在国际会议上展示。
这是第一项研究，调查了一种以患者为中心、生物心理社会跨学科方法的康复治疗在新冠后疾病患者中的效果。我们的研究结果将有助于改善新冠后疾病患者的治疗和支持。
德国临床试验注册处 DRKS00032636；https://drks.de/search/en/trial/DRKS00032636。
国际注册报告标识符（IRRID）：DERR1-10.2196/63951。
