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

April 26, 2024 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Estimated)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Karima MESBAHI IHADJADENE, Project Manager
  • Phone Number: +33 1 58 41 12 11
  • Email: karima.mesbahi@aphp.fr

Study Locations

  • France
      • Paris, France, 75004
        • Recruiting
        • Hôtel Dieu Hospital
        • Contact:
        • Sub-Investigator:
          • Brigitte Ranque, MD, PhD
        • Sub-Investigator:
          • Patricia Thoreux, MD, PhD
        • Sub-Investigator:
          • Anne-Sophie Rigaud, MD, PhD
        • Sub-Investigator:
          • Clément Gouraud, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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)
Behavioral: Personalized multidisciplinary day-hospital 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)
No Intervention: Control
Usual care (waiting list)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: 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)
at 6 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: at 3 Months
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
Time Frame: at 3 months, 6 months
Pichot's scale global score - may vary between 0 and 32. A score above 22 reveals excessive fatigue
at 3 months, 6 months
Cognitive complaint
Time Frame: at 3 months, 6 months
Mac Nair & Kahn (1983) cognitive difficulties questionnaire, French GRECO consensus version
at 3 months, 6 months
Pain
Time Frame: at 3 months, 6 months
Numerical rating scale - from 0 (no pain) to 10 (the maximum imaginable pain)
at 3 months, 6 months
Physical fitness
Time Frame: at inclusion, 3 months, 6 months
Global physical activity questionnaire (GPAQ) score
at inclusion, 3 months, 6 months
Post-effort heart rate
Time Frame: at inclusion, 3 months, 6 months
Difference between estimated and measured heart rate (HR) at the end of the walking test
at inclusion, 3 months, 6 months
Weight loss
Time Frame: at inclusion, 3 months, 6 months
% weight loss
at inclusion, 3 months, 6 months
BMI
Time Frame: at inclusion, 3 months, 6 months
BMI
at inclusion, 3 months, 6 months
Blood albumin
Time Frame: at inclusion, 3 months, 6 months
Blood albumin
at inclusion, 3 months, 6 months
Nutritional risk
Time Frame: at inclusion, 3 months, 6 months
Nutritional risk index
at inclusion, 3 months, 6 months
Health beliefs associated with persistent symptoms
Time Frame: at inclusion, 3 months, 6 months
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
Dyspnea
Time Frame: at 3 months, 6 months
Borg scale (0 min-10 max)
at 3 months, 6 months
Patient's satisfaction
Time Frame: at 3 months, 6 months
Ad hoc questionnaire
at 3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Cédric Lemogne, MD, PhD, AP-HP and Université Paris Cité

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2023

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

July 12, 2022

First Submitted That Met QC Criteria

September 7, 2022

First Posted (Actual)

September 8, 2022

Study Record Updates

Last Update Posted (Actual)

April 30, 2024

Last Update Submitted That Met QC Criteria

April 26, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP220357
  • 2022-A00268-35 (Other Identifier: ID-RCB Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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