Evaluation and Comparison of Multidisciplinary Day-hospital Versus Waiting List Management of Persistent Symptoms After an Acute Episode of COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Quality of life
研究概览
简要总结
After an acute episode of COVID-19, many patients experience persistent or recurrent symptoms with substantial impairment of their quality of life. The most common symptoms are fatigue, dyspnea, cognitive impairment and pain, but symptoms of all types have been reported. The heterogeneity of symptoms and their potential pathophysiology makes individualized and multidisciplinary management essential.
The primary objective of this study is to evaluate the change in quality of life at 6 months in patients with persistent symptoms after an acute episode of COVID-19 after 6 weeks of personalized multidisciplinary outpatient management versus usual care.
详细描述
After an acute episode of COVID-19, many patients experience persistent or recurrent symptoms with substantial impairment of their quality of life. The most common symptoms are fatigue, dyspnea, cognitive impairment, and pain, but symptoms of all types have been reported. The heterogeneity of symptoms and their potential pathophysiology makes individualized and multidisciplinary management essential.
The primary objective is to evaluate the change in quality of life at 6 months in patients with persistent symptoms after an acute episode of COVID-19 after 6 weeks of personalized multidisciplinary outpatient management versus usual care. The secondary objectives are to evaluate the evolution of the quality of life at 3 months, the evolution of the main persistent symptoms (fatigue, dyspnea, cognitive complaints, pain), the patients' satisfaction, the predictive and explanatory factors of the evolution.
This is a prospective randomized open-label study in two parallel arms: personalized multidisciplinary outpatient intervention versus usual care (waiting list). This 6-week program of care will include:
- group education sessions including a psycho-education component (1 session / week)
- a personalized exercise training protocol (from 1 session of supervision to 3 sessions of guided exercise per week) adapted to the results of the VO2max exercise test
- if dysfunctional health beliefs are identified (SSD-12 score ≥ 26): group cognitive and behavior therapy (2 sessions per week, including at least 1 in person).
- if cognitive complaints and/or neuropsychological impairment: a cognitive remediation protocol (1 group session plus 2 home sessions per week)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having had an initial episode of symptomatic COVID-19 according to one of the following criteria:
- •SARS-Cov-2 PCR +
- •SARS-Cov-2 + antigenic test
- •SARS-Cov-2 + serology
- •Prolonged anosmia/ageusia of sudden onset
- •Typical chest CT scan
- •Still having at least one of the initial symptoms and possibly new symptoms including fatigue, dyspnea, cognitive impairment or pain beyond 4 weeks after the onset of the acute phase of the disease.
- •These initial and persistent symptoms are not better explained by another diagnosis not known to be related to Covid-
- •These symptoms are the cause of an alteration in quality of life and global functioning deemed significant by the patient.
- •Having an indication to either supervised exercise and / or cognitive behavior therapy and / or cognitive remediation
排除标准
- •Medical emergency requiring management not compatible with research
- •Neuropsychiatric disorder likely to alter cognitive functions, prior to the Covid-19 episode
- •Medical contraindication to exercise training such as pericarditis or progressive myocarditis
- •Patient under state medical assistance
- •Patient who does not speak French
- •Pregnancy in progress
研究组 & 干预措施
Intervention
This 6-week program of care will include:
- group education sessions including a psycho-education component (1 session / week)
- a personalized exercise training protocol (from 1 session of supervision to 3 sessions of guided exercise per week) adapted to the results of the VO2max exercise test.
- if dysfunctional health beliefs are identified (SSD-12 score ≥ 26): a group protocol of cognitive and behavior therapy (2 sessions per week, including at least 1 in person).
- if cognitive complaints and/or neuropsychological impairment: a cognitive remediation protocol (1 group session plus 2 home sessions per week)
干预措施: Personalized multidisciplinary day-hospital intervention (Behavioral)
Control
Usual care (waiting list)
结局指标
主要结局
Quality of life
时间窗: at 6 Months
SF-12 global score - 12-item Short Form Survey (SF-12) is a general health questionnaire. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12)
次要结局
- Quality of life(at 3 Months)
- Dyspnea(at 3 months, 6 months)
- Pain(at 3 months, 6 months)
- Patient's satisfaction(at 3 months, 6 months)
- Fatigue(at 3 months, 6 months)
- Cognitive complaint(at 3 months, 6 months)
- Post-effort heart rate(at inclusion, 3 months, 6 months)
- BMI(at inclusion, 3 months, 6 months)
- Nutritional risk(at inclusion, 3 months, 6 months)
- Health beliefs associated with persistent symptoms(at inclusion, 3 months, 6 months)
- Physical fitness(at inclusion, 3 months, 6 months)
- Weight loss(at inclusion, 3 months, 6 months)
- Blood albumin(at inclusion, 3 months, 6 months)