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

Primary Purpose

Post COVID-19 Condition

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Personalized multidisciplinary day-hospital intervention
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post COVID-19 Condition focused on measuring Randomized controlled trial, Cognitive behavior therapy, Physical exercise, Cognitive remediation, Post covid-19 condition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôtel Dieu HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Intervention

Control

Arm Description

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)

Usual care (waiting list)

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
Fatigue
Pichot's scale global score - may vary between 0 and 32. A score above 22 reveals excessive fatigue
Dyspnea
mMRC score
Cognitive complaint
Mac Nair & Kahn (1983) cognitive difficulties questionnaire, French GRECO consensus version
Pain
Numerical rating scale - from 0 (no pain) to 10 (the maximum imaginable pain)
Patient's satisfaction
Ad hoc questionnaire
Physical fitness
Global physical activity questionnaire (GPAQ) score
Post-effort heart rate
Difference between estimated and measured heart rate (HR) at the end of the walking test
Weight loss
% weight loss
BMI
BMI
Blood albumin
Blood albumin
Nutritional risk
Nutritional risk index
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

Full Information

First Posted
July 12, 2022
Last Updated
February 6, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT05532904
Brief Title
Multidisciplinary Day-hospital Versus Waiting List Management of Post-COVID-19 Persistent Symptoms (ECHAP-COVID)
Acronym
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 18, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post COVID-19 Condition
Keywords
Randomized controlled trial, Cognitive behavior therapy, Physical exercise, Cognitive remediation, Post covid-19 condition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Other
Arm Description
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)
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care (waiting list)
Intervention Type
Behavioral
Intervention Name(s)
Personalized multidisciplinary day-hospital intervention
Intervention Description
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)
Primary Outcome Measure Information:
Title
Quality of life
Description
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
Secondary Outcome Measure Information:
Title
Quality of life
Description
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
Title
Fatigue
Description
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
Title
Dyspnea
Description
mMRC score
Time Frame
at 3 months, 6 months
Title
Cognitive complaint
Description
Mac Nair & Kahn (1983) cognitive difficulties questionnaire, French GRECO consensus version
Time Frame
at 3 months, 6 months
Title
Pain
Description
Numerical rating scale - from 0 (no pain) to 10 (the maximum imaginable pain)
Time Frame
at 3 months, 6 months
Title
Patient's satisfaction
Description
Ad hoc questionnaire
Time Frame
at inclusion, 3 months, 6 months
Title
Physical fitness
Description
Global physical activity questionnaire (GPAQ) score
Time Frame
at inclusion, 3 months, 6 months
Title
Post-effort heart rate
Description
Difference between estimated and measured heart rate (HR) at the end of the walking test
Time Frame
at inclusion, 3 months, 6 months
Title
Weight loss
Description
% weight loss
Time Frame
at inclusion, 3 months, 6 months
Title
BMI
Description
BMI
Time Frame
at inclusion, 3 months, 6 months
Title
Blood albumin
Description
Blood albumin
Time Frame
at inclusion, 3 months, 6 months
Title
Nutritional risk
Description
Nutritional risk index
Time Frame
at inclusion, 3 months, 6 months
Title
Health beliefs associated with persistent symptoms
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cédric Lemogne, MD, PhD
Phone
+33 1 42 34 84 35
Email
cedric.lemogne@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Karima MESBAHI IHADJADENE, Project Manager
Phone
+33 1 58 41 12 11
Email
karima.mesbahi@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cédric Lemogne, MD, PhD
Organizational Affiliation
AP-HP and Université Paris Cité
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôtel Dieu Hospital
City
Paris
ZIP/Postal Code
75004
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cédric Lemogne, MD, PhD
Phone
+33 1 42 34 84 35
Email
cedric.lemogne@aphp.fr
First Name & Middle Initial & Last Name & Degree
Brigitte Ranque, MD, PhD
First Name & Middle Initial & Last Name & Degree
Patricia Thoreux, MD, PhD
First Name & Middle Initial & Last Name & Degree
Anne-Sophie Rigaud, MD, PhD
First Name & Middle Initial & Last Name & Degree
Clément Gouraud, MD

12. IPD Sharing Statement

Plan to Share IPD
No
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Multidisciplinary Day-hospital Versus Waiting List Management of Post-COVID-19 Persistent Symptoms (ECHAP-COVID)

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