Interprofessional Rehabilitation for Patients With Cognitive Dysfunction and Fatigue After COVID-19 Infection.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Canadian Occupational Performance Measure (COPM)
研究概览
简要总结
Since 2020, millions of individuals have been infected with SARS-CoV-2 virus and a substantial proportion continue to experience persistent symptoms that impair functional capacity, limit daily activities, and negatively affect quality of life. The terminology and definitions surrounding this condition remain diverse, such as long COVID, post-COVID-19 syndrome or ongoing symptomatic COVID-19 . In October 2021, the World Health Organization (WHO) introduced the term post-COVID condition (PCC) through a Delphi consensus process defined as:
"As the persistence or onset of new symptoms three months after the initial SARS-CoV-2 infection, with symptoms lasting for at least two months and not explained by alternative diagnoses".
PCC is characterized by a wide range of symptoms, most commonly fatigue, cognitive impairments, muscle weakness, respiratory and cardiac symptoms, and pain often occurring alongside anxiety, depression, and sleep disturbances. Research shows that PCC markedly impairs activities of daily living (ADL), work ability, and overall functioning. Qualitative studies further demonstrate that the combination of physical and cognitive symptoms limits individuals' ability to engage in everyday occupations and reduce work capacity. Consequently, PCC is associated with difficulties in maintaining employment, often resulting in prolonged sick leave, reduced working hours, or the need for workplace accommodations. Given the heterogeneous nature of PCC, its impact on everyday life varies between individuals, highlighting the importance of understanding patients´ own experiences and priorities when planning rehabilitation interventions.
Global efforts have focused on understanding and managing PCC, with rehabilitation emerging as a central strategy. Rehabilitation strategies seem to be a key intervention for improving fatigue, cognitive dysfunction, mood disturbances, and decrease overall well-being; however, current evidence is heterogeneous and insufficient to establish standardized interventions. A lack of research on PCC patients would lead to profound consequences for both patients and society. Without such knowledge, patients' risk of being misdiagnosed or receiving inadequate care, rehabilitation efforts may be ineffective, and healthcare systems will struggle to allocate resources properly. This increases long-term disability, reduces work ability, and places an avoidable burden on individuals and society. Therefore, a deeper understanding of the scope and nature of PCC is essential for understanding this patient group better, developing effective rehabilitation approaches and informing public health policy.
The goal of this observational study is to learn more about the impact of post-COVID condition (PCC) on individuals' everyday occupational performance, cognitive functioning, perceived health, and life satisfaction, with the aim of understanding these patient groups better, and to generate evidence to guide rehabilitation strategies. The research focuses on patients diagnosed with post-COVID condition who are receiving an interprofessional rehabilitation program at a specialized Rehabilitation Clinic in Sweden, Danderyds Hospital,
The main questions aim to answer are:
- Which activities do individuals with PCC identify as most important to improve, and how do they rate these activities in terms of performance and satisfaction?
- How do individuals with PCC rate their overall health and occupational performance before and after participating in an interprofessional rehabilitation program?
详细描述
This is a prospective clinical cohort study, describing occupational performance, cognitive dysfunction and health aspects within patients with post-COVID condition (PCC), which have participated in an interprofessional rehabilitation program. Data collection began in 2021 and continued through 2025. Participants were recruited prior to initiation of rehabilitation and assessed at baseline, immediately post-intervention, and at six-month follow-up.
Setting The study was conducted at the Stockholm Department of Rehabilitation Medicine, Danderyd University Hospital, within the Cognitive Post-COVID Clinic .
Participants Between August 2021 and December 2025, patients with persistent cognitive symptoms and fatigue following mild COVID-19 infection were assessed for eligibility. A total of approximately 100 patients aged 18-65 years were included.
All patients underwent a comprehensive interdisciplinary assessment to determine the need for and potential benefit from interprofessional multimodal rehabilitation (IMR). Only patients who provided written informed consent were enrolled in the study.
Intervention:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged 18 and older with confirmed COVID-19 or with a very likely prior COVID-19 infection.
- •Newly developed cognitive impairments or cognitive fatigue.
- •-A clear temporal link between COVID-19 onset and symptom onset, with symptoms affecting return to previous activities/occupation.
- •The acute phase of illness ended at least 3 months earlier.
- •Basic investigations for specific differential diagnoses must have been completed at the initial clinic visit, according to "COVID-19 - persistent symptoms" (see viss.nu), excluding anemia, thyroid dysfunction, and alcohol overconsumption. Assessment for depression.
- •Medication review and relevant adjustments carried out with regard to the patient's symptoms
排除标准
- •Predominant recurrent and/or fluctuating infectious symptoms, circulatory, respiratory, or cardiac problems.
- •Other symptoms due to organ failure that should primarily be managed by an organ specialist.
- •Severe psychiatric illness, including depression with pronounced cognitive symptoms.
- •Cognitive impairments primarily related to neurodegenerative disease or substance misuse, e.g., alcohol-related dementia, Korsakoff's dementia, or other dementia disorders.
研究组 & 干预措施
Patients with Post-COVID condition
The study aims to investigate a cohort of patients with post COVID condition whose primary symptoms are cognitive impairment and fatigue. The patients have undergone a comprehensive assessment by a multiprofessional team and have been deemed both to require and to be capable of participating in an on site interprofessional rehabilitation program conducted one day per week.
干预措施: Interprofessional cognitive group rehabilitation (Other)
结局指标
主要结局
Canadian Occupational Performance Measure (COPM)
时间窗: Before, after and at six months follow-up
The COPM assesses an individual's perceived occupational performance in the areas of self-care, productivity and leisure. Semi-structured interview format and structured scoring method. The person rates/ describes which activities are important for them and after that satisfaction. The person rates importance, performance and satisfaction
次要结局
- EQ5D(Before, after and at six month follow-up)
- HADS(Before, after and six month follow-up)
- Rand-36(Before, after and a six months follow-up)
- MFI-20(Before, after and at six months follow-up)
- ISI(Before, after and at six month follow-up)
- WHODAS-12(Before, after and at six month follow-up)
