EMPATY: Education of Medical Staff to Post Acute Covid susTained sYmptoms

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06082258

Collaborator

ANRS, Emerging Infectious Diseases (Other)

672

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post-acute COVID-19 Syndrome	Other: Training in the management of functional disorders Other: Reimbursement of 3 long consultations	N/A

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:

To assess the effectiveness 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:

Stepped wedge controlled randomized trial: randomization of the order in which CACL will receive the intervention. After an observation phase during which the follow-up of the patients will be done according to the usual management of the care, the training of the CACL (intervention) will take place over 36 weeks. The intervention will include:

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.
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.
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:

In order to detect a difference of at least 3 points in the mean composite physical score (PCS) SF-12 at 3 months with a power of 80%, the investigators plan to include 112 subjects per cluster (n = 6) i.e. 672 subjects in total. A total of 6 clusters will be considered with 7 periods of 6 weeks (1 observation period without training of healthcare teams and 6 training periods).

The PCS 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 the cluster effect of the randomization by the inclusion in the model of a random effect on the cluster and the adjustment on the PCS at baseline.

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

672 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

Stepped wedge study : all GP will eventually receive the training during the study period, but the time of their training is randomly assignedStepped wedge study : all GP will eventually receive the training during the study period, but the time of their training is randomly assigned

Masking:

Single (Participant)

Primary Purpose:

Health Services Research

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Mar 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: usual care Patients followed by general practitioners with no specific education on long COVID or somatic symptom disorders
Experimental: 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	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

Arm

Intervention/Treatment

No Intervention: usual care

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

Experimental: 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

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

Outcome Measures

Primary Outcome Measures

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 [3 months]
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.

Secondary Outcome Measures

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 [1 month]
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.
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 [6 months]
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.
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 [1 month]
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.
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 [3 months]
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.
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 [6 months]
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.
Change of clinical global impression (CGI scores) of the patient at 1 month compared to the last available clinical evaluation [1 month]
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.
Change of clinical global impression (CGI scores) of the patient at 3 months compared to the last available clinical evaluation [3 months]
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.
Change of clinical global impression (CGI scores) of the patient at 6 months compared to the last available clinical evaluation [6 months]
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.
Frequency of patient care consultations at 1 month [1 month]
Number of patient care consultations between inclusion and 1-month follow-up
Frequency of patient care consultations at 3 months [3 months]
Number of patient care consultations between inclusion and 3-month follow-up
Frequency of patient care consultations at 6 months [6 months]
Number of patient care consultations between inclusion and 6-month follow-up

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Paris Nord (CPTS 10e)	Paris	France	75010
2	Paris Est (CPTS 12e et 20e)	Paris	France	75012
3	DAC 75	Paris	France	75013
4	Paris Sud (CPTS 13-14e)	Paris	France	75013
5	Paris Ouest (CPTS 15e)	Paris	France	75015
6	DAC 93	Saint-Denis	France	93200
7	DAC 92	Suresnes	France	92150