Education of Medical Staff to Post Acute Covid susTained sYmptoms

NCT ID: NCT06082258

Last Updated: 2024-07-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-30
• Study Completion Date: 2026-05-31

Brief 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.

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.

Conditions

Post-acute COVID-19 Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

usual care

Patients followed by general practitioners with no specific education on long COVID or somatic symptom disorders

Group Type: NO_INTERVENTION

No interventions assigned to this group

intervention

Patients 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

Group Type: EXPERIMENTAL

Training in the management of functional disorders

Intervention Type: OTHER

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

Reimbursement of 3 long consultations

Intervention Type: OTHER

3 long consultations (1 hour) reimbursed for each patient

Interventions

Training in the management of functional disorders

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

Intervention Type: OTHER

Reimbursement of 3 long consultations

3 long consultations (1 hour) reimbursed for each patient

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ANRS, Emerging Infectious Diseases

OTHER_GOV

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brigitte Ranque, Pr

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

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

Countries

France

Central Contacts

Tiffany Martin

Role: CONTACT

tiffany.martin@aphp.fr

+33 1 44 84 17 92

Facility Contacts

Jeanne VILLENEUVE

Role: primary

jeanne.villeneuve@richerand.fr

Vincent MIRAMONT

Role: primary

vincemiramont@gmail.com

Marie-Laure ALBY

Role: primary

ml.alby@yahoo.fr

Marie-Laure ALBY

Role: primary

ml.alby@yahoo.fr

Yannis CHARLON

Role: primary

y_charlon@hotmail.fr

Bao Hoa DANG

Role: primary

baohoa.dang@arcenciel-93nord.fr

Ingrid REDMOND

Role: primary

ingrid.redmond@dac92centre.fr

Other Identifiers

ECTZ199383

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2022-A00531-42

Identifier Type: REGISTRY

Identifier Source: secondary_id

DR-2023-132

Identifier Type: OTHER

Identifier Source: secondary_id

APHP220136

Identifier Type: -

Identifier Source: org_study_id