Clinical Epidemiology Program, Ottawa Hospital Research Institute, 1919 Riverside Drive, Suite 406, Ottawa, ON, Canada.
Department of Psychiatry, University of Ottawa, 5457-1145 Carling Avenue, Ottawa, ON, Canada.
Trials. 2022 Sep 2;23(1):728. doi: 10.1186/s13063-022-06578-1.
As of May 2022, Ontario has seen more than 1.3 million cases of COVID-19. While the majority of individuals will recover from infection within 4 weeks, a significant subset experience persistent and often debilitating symptoms, known as "post-COVID syndrome" or "Long COVID." Those with Long COVID experience a wide array of symptoms, with variable severity, including fatigue, cognitive impairment, and shortness of breath. Further, the prevalence and duration of Long COVID is not clear, nor is there evidence on the best course of rehabilitation for individuals to return to their desired level of function. Previous work with chronic conditions has suggested that the addition of electronic case management (ECM) may help to improve outcomes. These platforms provide enhanced connection with care providers, detailed symptom tracking and goal setting, and access to relevant resources. In this study, our primary aim is to determine if the addition of ECM with health coaching improves Long COVID outcomes at 3 months compared to health coaching alone.
The trial is an open-label, single-site, randomized controlled trial of ECM with health coaching (ECM+) compared to health coaching alone (HC). Both groups will continue to receive usual care. Participants will be randomized equally to receive health coaching (± ECM) for a period of 8 weeks and a 12-week follow-up. Our primary outcome is the WHO Disability Assessment Scale (WHODAS), 36-item self-report total score. Participants will also complete measures of cognition, fatigue, breathlessness, and mental health. Participants and care providers will be asked to complete a brief qualitative interview at the end of the study to evaluate acceptability and implementation of the intervention.
There is currently little evidence about the optimal treatment of Long COVID patients or the use of digital health platforms in this population. The results of this trial could result in rapid, scalable, and personalized care for people with Long COVID which will decrease morbidity after an acute infection. Results from this study will also inform decision making in Long COVID and treatment guidelines at provincial and national levels.
ClinicalTrials.gov NCT05019963. Registered on 25 August 2021.
截至 2022 年 5 月，安大略省已出现超过 130 万例 COVID-19 病例。虽然大多数人会在 4 周内从感染中康复，但仍有相当一部分人会出现持续且常常使人衰弱的症状，称为“新冠后综合征”或“长新冠”。患有长新冠的人会出现各种症状，其严重程度各不相同，包括疲劳、认知障碍和呼吸急促。此外，长新冠的患病率和持续时间尚不清楚，也没有证据表明哪些康复方法最适合个人恢复到他们期望的功能水平。先前针对慢性疾病的研究表明，增加电子病例管理（ECM）可能有助于改善结果。这些平台提供了与护理提供者的更紧密联系、详细的症状跟踪和目标设定，以及获取相关资源的途径。在这项研究中，我们的主要目的是确定与单独健康辅导相比，增加 ECM 和健康辅导是否能在 3 个月时改善长新冠的结果。
该试验是一项开放标签、单站点、随机对照试验，比较 ECM 加健康辅导（ECM+）与单独健康辅导（HC）。两组都将继续接受常规护理。参与者将被平均随机分配接受健康辅导（± ECM）8 周，并进行 12 周的随访。我们的主要结果是世界卫生组织残疾评估量表（WHODAS）36 项自我报告总分。参与者还将完成认知、疲劳、呼吸困难和心理健康的测量。研究结束时，参与者和护理提供者将被要求完成简短的定性访谈，以评估干预措施的可接受性和实施情况。
目前关于长新冠患者的最佳治疗方法或在该人群中使用数字健康平台的证据很少。该试验的结果可能会为长新冠患者提供快速、可扩展和个性化的护理，从而减少急性感染后的发病率。这项研究的结果还将为省级和国家级的长新冠和治疗指南的决策提供信息。
ClinicalTrials.gov NCT05019963。注册于 2021 年 8 月 25 日。
