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

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

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.

Not yet recruiting
Post-acute COVID-19 Syndrome

Other: Training in the management of functional disorders

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

Other: Reimbursement of 3 long consultations

3 long consultations (1 hour) reimbursed for each patient

Eligibility Criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
France
Locations

Paris Nord (CPTS 10e)
Paris, France

Paris Est (CPTS 12e et 20e)
Paris, France

DAC 75
Paris, France

Paris Sud (CPTS 13-14e)
Paris, France

Paris Ouest (CPTS 15e)
Paris, France

DAC 93
Saint-Denis, France

DAC 92
Suresnes, France

Contacts

Tiffany Martin
+33 1 44 84 17 92
tiffany.martin@aphp.fr

Brigitte Ranque, Pr, Principal Investigator
Assistance Publique - Hôpitaux de Paris

ANRS, Emerging Infectious Diseases
NCT Number
Keywords
long COVID
Post acute Covid syndrome
somatic symptom disorder
Education
MeSH Terms
COVID-19
Post-Acute COVID-19 Syndrome