Clinical trial NCT05532904: Multidisciplinary Day-hospital Versus Waiting List Management of Post-COVID-19 Persistent Symptoms (ECHAP-COVID)
Official title: Evaluation and Comparison of Multidisciplinary Day-hospital Versus Waiting List Management of Persistent Symptoms After an Acute Episode of COVID-19
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Post COVID-19 Condition
Keywords: Randomized controlled trial
Cognitive behavior therapy
Physical exercise
Cognitive remediation
Post covid-19 condition
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-09-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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)

Eligibility criteria: 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

Primary outcomes:
measure: Quality of life
timeFrame: at 6 Months
Secondary outcomes:
measure: Quality of life
timeFrame: at 3 Months
measure: Fatigue
timeFrame: at 3 months, 6 months
measure: Dyspnea
timeFrame: at 3 months, 6 months
measure: Cognitive complaint
timeFrame: at 3 months, 6 months
measure: Pain
timeFrame: at 3 months, 6 months
measure: Patient's satisfaction
timeFrame: at 3 months, 6 months
measure: Physical fitness
timeFrame: at inclusion, 3 months, 6 months
measure: Post-effort heart rate
timeFrame: at inclusion, 3 months, 6 months
measure: Weight loss
timeFrame: at inclusion, 3 months, 6 months
measure: BMI
timeFrame: at inclusion, 3 months, 6 months
measure: Blood albumin
timeFrame: at inclusion, 3 months, 6 months
measure: Nutritional risk
timeFrame: at inclusion, 3 months, 6 months
measure: Health beliefs associated with persistent symptoms
timeFrame: at inclusion, 3 months, 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôtel Dieu Hospital
Study officials:
affiliation: AP-HP and Université Paris Cité
name: Cédric Lemogne, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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