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Post-acute COVID-19 SyndromeEMPATYNCT06082258

Education of Medical Staff to Post Acute Covid susTained sYmptoms

A study testing Training in the management of functional disorders and Reimbursement of 3 long consultations in people with Post-acute COVID-19 Syndrome, run by Assistance Publique - Hôpitaux de Paris at 7 sites in France.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Evaluation of the effectiveness of a training and support intervention for general practitioners treating patients with persistent symptoms after a COVID-19 episode on the patients'quality of life at 3 months. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Post-acute COVID-19 Syndrome
What is being tested?
Training in the management of functional disorders and Reimbursement of 3 long consultations
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
7 sitesFrance
Study dates
Nov 2024to May 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • at least two symptoms attributed to COVID-19 (including fatigue, dyspnea, cognitive impairment or pain); persistent for more than 2 months; not explained by a diagnosis unrelated to COVID-19;
  • a quality of life impairment considered significant by the patient.

Who cannot join

  • Refusal to participate in the study
  • Under 18 years of age
  • Persistent symptoms secondary to an objective sequelae from the initial episode of COVID-19.
  • Neuropsychiatric disorder that may impair cognitive function prior to COVID-19
  • Medical contraindication to physical training (pericarditis or myocarditis...)
  • Patient not affiliated with the social security system or under AME
  • Patient under guardianship, guardianship or guardianship

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

France7 sites
  • Paris Nord (CPTS 10e)

    Paris, 75010

  • Paris Est (CPTS 12e et 20e)

    Paris, 75012

  • DAC 75

    Paris, 75013

  • Paris Sud (CPTS 13-14e)

    Paris, 75013

  • Paris Ouest (CPTS 15e)

    Paris, 75015

  • DAC 93

    Saint-Denis, 93200

  • DAC 92

    Suresnes, 92150

Other trials in France

About this study

Official title: Evaluation of a Training and Support Intervention for General Practitioners Managing Patients With Persistent Symptoms Following a COVID-19 Episode

Evaluation of the effectiveness of a training and support intervention for general practitioners treating patients with persistent symptoms after a COVID-19 episode on the patients'quality of life at 3 months.

Read the detailed description

Apart from the objectivable sequelae of a severe COVID-19 episode, the pathophysiology of symptoms persisting several months after an acute COVID episode is not established. The investigators hypothesize that a substantial part of these symptoms are functional somatic disorders, defined by symptoms not explained by a lesion of the organ which they designate and which can benefit from an action on their cognitive and behavioural mechanisms including an adapted physical activity program. The frequency of these symptoms and their major impact justifies the development of an adapted care offer easily accessible, involving mainly general practitioners (GP). For example, the ARS has advocated for the development of "covid-long" support cells, whose role is to coordinate the management of patients with these symptoms by providing advice and referral to other professionals if necessary. Experience has shown that doctors are baffled by the very polymorphic symptomatology of these patients and often have difficulty managing their anxiety towards the symptoms.

Primary Objective:

Describe the impact of GP training accompanied by a Covid Long Support Cell (CACL) to manage persistent somatic functional symptoms attributed to COVID-19 on the quality of life of patients at 3 months.

The main criterion of evaluation will be the evolution of the SF-12 quality of life physical composite score at 3 months.

Methods:

Prospective observational study. An observation phase before training during which the monitoring of 4 to 6 patients by general practitioners will be carried out according to the usual care management. Subsequently, general practitioners will be trained (intervention) and after training, 4 to 6 patients per general practitioner will then be recruited. The intervention will include:

  1. Training delivered to CACL staff and volunteer general practitioners: online theoretical courses and video capsules produced with actors, discussed with learners, an expert doctor and an expert patient (several training sessions will be organized during the study).
  2. Reimbursement for each patient of 3 long consultations (1 hour) with a participating general practitioner and an assessment by an adapted physical activity teacher during the first month of the patient's participation.
  3. Follow-up of the patient by telephone interview at inclusion then at 1, 3 and 6 months after inclusion: physical and mental components of the SF-12, intensity of symptoms; healthcare consumption, work stoppage, physician satisfaction and patient experience, 1, 3 and 6 months.

Study population: patients managed by one of the 6 CACL of Ile de France.

Statistical Analysis:

The objective of the study is to describe the impact of the training of private general practitioners, accompanied by a support and coordination unit, for the management of persistent functional somatic symptoms attributed to COVID-19, on the quality of life linked to the physical health of patients at 3 months. The number of subjects to be included is set at 400 to be able to examine the results with sufficient precision within an acceptable time frame taking into account the expected rate of inclusion of approximately 1 patient per month, per general practitioner over a period of 14 months.

Assuming an average SF-12 SCP at 3 months of 31 in the control group with a standard deviation of 8 based on the results of the SF-12 questionnaire carried out in a sample of 216 patients with long COVID having consulted at the Hôtel-Dieu, a total of 400 patients will demonstrate an average SF-12 SCP at 3 months of 34 in the experimental group, with an alfa risk of 5% and a power of 96%.

The study will be systematically offered to all patients referred by their treating physician or who refer themselves to a CACL for prolonged symptoms attributed to "long COVID", this will best ensure good representativeness of the sample.

The SCP of the SF-12 questionnaire at 3 months will be compared between the patients included before and after the training using a mixed linear regression, taking into account in the model a random effect on the general practitioner and the adjustment on the SCP at inclusion.

The secondary objectives will also be analyzed using appropriate mixed models depending on the type of variables analyzed, considering the general practitioner as a random effect.

Being tested
Training in the management of functional disorders, Reimbursement of 3 long consultations
Keywords
Long COVID, Post acute Covid syndrome, Somatic symptom disorder, Education
Medical subject headings
Post-Acute COVID-19 Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Training in the management of functional disordersOther

    Theoritical and practical training of GP in long COVID and somatic symptom disorders management

  • Reimbursement of 3 long consultationsOther

    3 long consultations (1 hour) reimbursed for each patient

Study groups in NCT06082258
Study groupRoleWhat they receive
usual careNo interventionPatients followed by general practitioners with no specific education on long COVID or somatic symptom disorders
interventionExperimentalPatients followed by general practitioners who have received a training in long COVID and somatic symptom disorders diagnosis and treatment, with reimbursement of three long consultations
Receives: Other: Training in the management of functional disorders; Other: Reimbursement of 3 long consultations

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of physical component summary (PCS) of 12-Item Short-Form Health Survey (SF-12v2) - quality of life scale at 3 months compared to the PCS at the inclusion of the patient

    Health-related quality of life variable measured using the Short Form Health Survey (SF-12v2): 12-item self-report that assesses physical and mental health related quality of life. The physical component summary (PCS) will be used. Normalized score ranges from 0 to 100, with higher scores indicating better physical health functioning.

    Measured: 3 months

Secondary outcomes (11)
  1. Change of physical component summary (PCS) of 12-Item Short-Form Health Survey (SF-12v2) - quality of life scale at 1 month compared to the PCS at the inclusion of the patient

    Health-related quality of life variable measured using the Short Form Health Survey (SF-12v2): 12-item self-report that assesses physical and mental health related quality of life. The physical component summary (PCS) will be used. Normalized score ranges from 0 to 100, with higher scores indicating better physical health functioning.

    Measured: 1 month

  2. Change of physical component summary (PCS) of 12-Item Short-Form Health Survey (SF-12v2) - quality of life scale at 6 months compared to the PCS at the inclusion of the patient

    Health-related quality of life variable measured using the Short Form Health Survey (SF-12v2): 12-item self-report that assesses physical and mental health related quality of life. The physical component summary (PCS) will be used. Normalized score ranges from 0 to 100, with higher scores indicating better physical health functioning.

    Measured: 6 months

  3. Change of mental component summary (MCS) of 12-Item Short-Form Health Survey (SF-12v2) - quality of life scale at 1 month compared to the MCS at the inclusion of the patient

    Health-related quality of life variable measured using the Short Form Health Survey (SF-12v2): 12-item self-report that assesses physical and mental health related quality of life. The mental component summary (MCS) will be used. Normalized score ranges from 0 to 100, with higher scores indicating better mental health functioning.

    Measured: 1 month

  4. Change of mental component summary (MCS) of 12-Item Short-Form Health Survey (SF-12v2) - quality of life scale at 3 months compared to the MCS at the inclusion of the patient

    Health-related quality of life variable measured using the Short Form Health Survey (SF-12v2): 12-item self-report that assesses physical and mental health related quality of life. The mental component summary (MCS) will be used. Normalized score ranges from 0 to 100, with higher scores indicating better mental health functioning.

    Measured: 3 months

  5. Change of mental component summary (MCS) of 12-Item Short-Form Health Survey (SF-12v2) - quality of life scale at 6 months compared to the MCS at the inclusion of the patient

    Health-related quality of life variable measured using the Short Form Health Survey (SF-12v2): 12-item self-report that assesses physical and mental health related quality of life. The mental component summary (MCS) will be used. Normalized score ranges from 0 to 100, with higher scores indicating better mental health functioning.

    Measured: 6 months

  6. Change of clinical global impression (CGI scores) of the patient at 1 month compared to the last available clinical evaluation

    The CGI questionnaire is rated on a 7-point scale and score ranges range from 1 (very much improved) through to 7 (very much worse). Each component of the CGI is rated separately.

    The following components will be considered: fatigue, pain, breathing difficulties, attention and concentration problems, other persistent symptoms.

    Measured: 1 month

  7. Change of clinical global impression (CGI scores) of the patient at 3 months compared to the last available clinical evaluation

    The CGI questionnaire is rated on a 7-point scale and score ranges range from 1 (very much improved) through to 7 (very much worse). Each component of the CGI is rated separately.

    The following components will be considered: fatigue, pain, breathing difficulties, attention and concentration problems, other persistent symptoms.

    Measured: 3 months

  8. Change of clinical global impression (CGI scores) of the patient at 6 months compared to the last available clinical evaluation

    The CGI questionnaire is rated on a 7-point scale and score ranges range from 1 (very much improved) through to 7 (very much worse). Each component of the CGI is rated separately.

    The following components will be considered: fatigue, pain, breathing difficulties, attention and concentration problems, other persistent symptoms.

    Measured: 6 months

  9. Frequency of patient care consultations at 1 month

    Number of patient care consultations between inclusion and 1-month follow-up

    Measured: 1 month

  10. Frequency of patient care consultations at 3 months

    Number of patient care consultations between inclusion and 3-month follow-up

    Measured: 3 months

  11. Frequency of patient care consultations at 6 months

    Number of patient care consultations between inclusion and 6-month follow-up

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2023
  2. Study startNov 2024 (estimated)
  3. Primary completionDec 2025 (estimated)
  4. Study completionMay 2026 (estimated)

Why it stopped: The research was not feasible due to administrative and organizational constraints.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Sequential
Masking
Single blind
Who is masked
Participant
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06082258
Sponsor's protocol ID
APHP220136
Other IDs
ECTZ199383, 2022-A00531-42, DR-2023-132
Acronym
EMPATY
Status last verified
Jun 2026
First submitted
12 Oct 2023
Last updated
1 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

Questions about this trial

What is this clinical trial studying?

A study testing Training in the management of functional disorders and Reimbursement of 3 long consultations in people with Post-acute COVID-19 Syndrome, run by Assistance Publique - Hôpitaux de Paris at 7 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of physical component summary (PCS) of 12-Item Short-Form Health Survey (SF-12v2) - quality of life scale at 3 months compared to the PCS at the inclusion of the patient (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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