Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-28 @ 5:13 PM
Study NCT ID:
NCT06082258
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-11
First Post:
2023-10-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Education of Medical Staff to Post Acute Covid susTained sYmptoms
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Evaluation of a Training and Support Intervention for General Practitioners Managing Patients With Persistent Symptoms Following a COVID-19 Episode
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMPATY
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: