Post-acute COVID-19 Syndrome Clinical Trial
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.
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: 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. 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: 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. ;