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.
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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
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)
Hôtel Dieu Hospital
Paris, France
Quality of life
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)
Time frame: at 6 Months
Quality of life
SF-12 global score - 12-item Short Form Survey (SF-12) is a general health questionnaireTwo summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12)
Time frame: at 3 Months
Fatigue
Pichot's scale global score - may vary between 0 and 32. A score above 22 reveals excessive fatigue
Time frame: at 3 months, 6 months
Dyspnea
Borg scale (0 min-10 max)
Time frame: at 3 months, 6 months
Cognitive complaint
Mac Nair \& Kahn (1983) cognitive difficulties questionnaire, French GRECO consensus version
Time frame: at 3 months, 6 months
Pain
Numerical rating scale - from 0 (no pain) to 10 (the maximum imaginable pain)
Time frame: at 3 months, 6 months
Patient's satisfaction
Ad hoc questionnaire
Time frame: at 3 months, 6 months
Physical fitness
Global physical activity questionnaire (GPAQ) score
Time frame: at inclusion, 3 months, 6 months
Post-effort heart rate
Difference between estimated and measured heart rate (HR) at the end of the walking test
Time frame: at inclusion, 3 months, 6 months
Weight loss
% weight loss
Time frame: at inclusion, 3 months, 6 months
BMI
BMI
Time frame: at inclusion, 3 months, 6 months
Blood albumin
Blood albumin
Time frame: at inclusion, 3 months, 6 months
Nutritional risk
Nutritional risk index
Time frame: at inclusion, 3 months, 6 months
Health beliefs associated with persistent symptoms
SSD-12 global score- may vary between 0 and 48 points - Each of the three psychological sub-criteria of DSM-5 somatic symptom disorder (cognitive, affective, behavioral) is measured by four items with all item scores ranging between 0 and 4 (0 = never, 1 = rarely, 2 = sometimes, 3 = often, 4 = very often) Ratings are summed up to make a simple sum score
Time frame: at inclusion, 3 months, 6 months
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