Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Claire DAIEN, MD
CONTACT
Lead
University Hospital, Montpellier
Methodology: * We will conduct a Phase 2 to one phase trial with A'Hern design. * The patients included will have RA (ACR / EULAR 2010 criteria), with an active disease (2.6 \<DAS 28 \<5.1), and at least 3 risk factors among: BMI ≥25 kg / m², low physical activity , active smoking, periodontitis and anxiety. 1. The primary endpoint will be the number of patients for whom at least 2 or 3 risk factors (depending on whether 3 present or 4-5 present at baseline) are corrected / in the process of being corrected at 6 months. 2. The secondary endpoints will be: A) Acceptability: number of patients agreeing to participate in the protocol / total number of screened patients fulfilling the inclusion criteria; questionnaires with EVA carried out at the end of the program; Membership of the program: online completion of questionnaires, use of the accelerometer, participation in teleconsultations and organized group sessions. B) For each risk factors: number of patients who corrected it at 3 and 6 months. C) RA activity measured by DAS28-CRP + RAID questionnaire, biological markers D) Distribution of the different germs of the oral and faecal micobiota and diversity. * As risks factor are established chronically, we hypothesize that only 10% of patients would correct at least 2 or 3 risk factors over 6 months in the absence of intervention. The expected efficiency is 40%. * By recruiting 25 patients, we will have a power of 90% to demonstrate that the one-sided 95% confidence interval of the effectiveness of the intervention is greater than 10% (p (0) if the true value of effectiveness is 35% (p (1)). This demonstration will be made if 6 patients out of 25 are successful. Procedure: * 3 visits will be necessary for rheumatological and biological evaluations (inclusion +/- M0, M3 and M6). * All patients will have 2 periodontal visits (M0 and M6 for evaluation and scaling). Those with periodontitis will have other visits depending on the care to be performed. * The smoking patients will have teleconsultations (TC) with a tobacco specialist (S0, S4 and S8 then according to tobacco specialist). * All patients will have a TC with a dietitian (45 min 1st consultation with set goals) and those overweight will then have a TC every 15 days for 3 months. * All patients will have a TC with a sports doctor (assessment of physical activity and development of a personalized program, explanation of the pedometer provided). For those with low physical activity, a virtual group session of 45 min / week will be organized. * Patients with anxiety will have TC with a psychiatrist specializing in stress management, with training in the use of cardiac coherence from connected equipment given to the patient. * All the interventions will be coordinated on an existing platform (MyGoodLife) which allows the dietary assessment, the automatic report of connected objects (pedometer) and the organization of group sessions.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
