Multidisciplinary Day-hospital Versus Waiting List Management of Post-COVID-19 Persistent Symptoms (ECHAP-COVID)

Study Overview
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Brief Summary
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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.

Detailed Description
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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)

Official Title
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Evaluation and Comparison of Multidisciplinary Day-hospital Versus Waiting List Management of Persistent Symptoms After an Acute Episode of COVID-19

Conditions
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Post COVID-19 Condition

Intervention / Treatment
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* Behavioral: Personalized multidisciplinary day-hospital intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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-19. 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 Exclusion Criteria 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intervention<br>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) | Behavioral: Personalized multidisciplinary day-hospital intervention<br>* 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)<br>|
| No Intervention: Control<br>Usual care (waiting list) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | at 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | at 3 Months | 
| Fatigue | Pichot's scale global score - may vary between 0 and 32. A score above 22 reveals excessive fatigue | at 3 months, 6 months | 
| Dyspnea | mMRC score | at 3 months, 6 months | 
| Cognitive complaint | Mac Nair & Kahn (1983) cognitive difficulties questionnaire, French GRECO consensus version | at 3 months, 6 months | 
| Pain | Numerical rating scale - from 0 (no pain) to 10 (the maximum imaginable pain) | at 3 months, 6 months | 
| Patient's satisfaction | Ad hoc questionnaire | at inclusion, 3 months, 6 months | 
| Physical fitness | Global physical activity questionnaire (GPAQ) score | 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 | at inclusion, 3 months, 6 months | 
| Weight loss | % weight loss | at inclusion, 3 months, 6 months | 
| BMI | BMI | at inclusion, 3 months, 6 months | 
| Blood albumin | Blood albumin | at inclusion, 3 months, 6 months | 
| Nutritional risk | Nutritional risk index | 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 | at inclusion, 3 months, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized controlled trial, Cognitive behavior therapy, Physical exercise, Cognitive remediation, Post covid-19 condition