MY-EDUC — The Effectiveness of an ETP Programme in Myasthenia Gravis: a Proof-of-concept Study.
University Hospital, Grenoble •
Myasthénie
Suivi actifÀ vérifier
Résumé
MY-EDUC — The Effectiveness of an ETP Programme in Myasthenia Gravis: a Proof-of-concept Study.
est développé par University Hospital, Grenoble.
Le traitement est actuellement en À vérifier.
Il est associé à Myasthénie.
Son objectif thérapeutique principal est Traitement symptomatique.
Le statut actuel est : suivi actif.
À vérifier
Traitement symptomatique
À vérifier
University Hospital, Grenoble
Non renseigné
CONTEXTE. Myasthenia gravis is a rare neuromuscular junction disorder affecting one in five thousand people (ORPHA 589). It is a chronic condition that progresses in episodes. Its severity varies, ranging from the invisible disability of fatigue to respiratory distress requiring intensive care. Currently, 270 patients with myasthenia gravis are being treated at Grenoble University Hospital in the Reference Centre for Rare Neuromuscular Diseases.
The impact of this disease on quality of life is significant, and medication alone is not sufficient. However, to date, there are virtually no psychosocial interventions for patients with myasthenia gravis and no studies evaluating their effectiveness.
In this context, the Cognitive Behavioural Stress Management (CBSM) programme is one of the stress management programmes applied to chronic health conditions whose effectiveness has already been demonstrated, particularly in terms of treatment adherence, quality of life, patients' coping strategies in the face of a chronic illness, and the outcomes of medical treatments (Antoni, 2003; Antoni et al., 2002, 2006).
PRIMARY OBJECTIVE. Evaluation of the adaptation of an existing patient education programme, 'Living Better with Myasthenia', following the inclusion of an eight-session CBSM-based stress management module for adult patients living with myasthenia.
METHODOLOGY (brief). Adaptation of the CBSM programme to the specific characteristics of myasthenia gravis:
1. Focus groups: exploration of beliefs associated with stress in myasthenia gravis.
2. DELPHI group: validation of the adaptation of the ETP programme 'Living better with myasthenia gravis' implemented at CHUGA following the inclusion of a stress management module (CBSM).
Assessment of the feasibility of the MY-EDUC programme among groups of patients with myasthenia gravis.
PRIMARY OUTCOME MEASURE. Comparison of levels of anxiety, depression (HADS), perceived stress (PSS) and quality of life (SF-36) as self-reported by patients enrolled in the programme before and after the MY-EDUC intervention.
RESEARCH PROCEDURE. 1.1. FOCUS GROUPS. Expert patients and partner patients. They will be contacted via the list maintained by the rare disease healthcare network.
'General public' patients. A call for participants will be displayed in the CHUGA waiting room and circulated by partner organisations to their members.
The study will be presented to expert and partner patients, as well as to "walk-in" patients in the focus groups, using the contact details on the "rare disease healthcare network" lists and via posters. An information leaflet outlining the study and its objectives will be provided to them.
1.2. FEASIBILITY AND ACCEPTABILITY STUDY OF THE MY-EDUC PROGRAMME. 1.2.1. Participant inclusion. Patient eligibility. The assessment of patient eligibility will be carried out by a specialist doctor from the CHUGA Rare Disease Centre of Excellence during a routine consultation with the patient (routine care).
Participant inclusion. Once patient eligibility has been verified, the investigator from the CHUGA Rare Disease Centre, or a person to whom they have delegated this task, will contact the patient to invite them to participate in the MY-EDUC study. They will provide a verbal explanation of the study and hand over an information sheet during a follow-up consultation with the patient as part of routine care. If the patient volunteers to participate, they will give their consent to participate.
The patient's consent will be recorded in the medical record. 1.2.2. Baseline assessment (T0). In the week leading up to the first session of the MY-EDUC programme, participants will complete the baseline assessment online (using the LimeSurvey platform - secure servers at the University of Grenoble Alpes) with questionnaires presented in a randomised order.
1.2.3. Assessment during the intervention (T1). Based on repeated ecological measurements (Shiffman et al., 2008) via the study participants' mobile phones (two measurement points, before and after each session, randomly scheduled at least 36 hours apart, i.e. 16 measurements) using the free PielsSurvey software.
1.2.4. Final assessments (T2 and T3). Within one week of the final session of the MY-EDUC programme (T2: week 10 after T0), participants will complete a set of questionnaires electronically (using the LimeSurvey platform - secure servers at the University of Grenoble Alpes), with the validated questionnaires presented in a randomised order.
Ce pourcentage n’est pas une probabilité de succès clinique.
Il mesure uniquement la force de la classification automatique de l’objectif scientifique. Le calcul part de 45 points, ajoute 7 points par unité de poids du mot-clé le plus fortement détecté, puis est plafonné à 95 %. Exemple : un score maximal de 2 donne 45 + (2 × 7) = 59 %.
Ce score est heuristique et doit être vérifié dans le protocole ou une publication.
Description affichée depuis l’essai compatible NCT07512375, afin d’éviter le mélange entre plusieurs indications d’une même molécule.
Aucune incohérence majeure détectée entre la maladie, l’objectif et la description.
Transparence et qualité de la fiche
données vérifiables
ClassificationCohérente automatiquement
Confiance de la fiche100 %
Source principaleSource officielle ou publication indexée
Dernière vérification2026-03-30
Anomalies détectées0
Validation humaineValidation humaine non effectuée
Donnée issue d’une sourceDonnée normalisée automatiquementInterprétation algorithmique
Classification scientifique multi-axes
ne pas confondre statut et résultat
État de l’étudeRecrutement en cours
Disponibilité des résultatsRésultats à vérifier
InterprétationImpossible à déterminer
Niveau de preuveNon évaluable
Un essai terminé n’est pas nécessairement positif. Un essai arrêté n’est classé comme échec scientifique que lorsqu’un résultat ou une raison explicite le confirme.
Indicateurs factuels
sans score subjectif
Phase enregistréeÀ vérifier
Études associées1
Publications associées0
Statut consolidéSuivi actif
Aucune chance de succès, note d’innovation, potentiel thérapeutique ou probabilité de commercialisation n’est calculé tant qu’un modèle validé et des données suffisantes ne sont pas disponibles.
Historique factuel de la molécule
4 événement(s) daté(s)
Cette liste reprend uniquement les dates trouvées dans les registres et publications liés. Elle ne constitue pas une prévision.
Date
Événement
Source
2026-03-30
Dernière mise à jour des donnéesMY-EDUC — The Effectiveness of an ETP Programme in Myasthenia Gravis: a Proof-of-concept Study.
Ces sources sont proposées pour vérification. Les informations de la fiche doivent être confirmées dans les registres officiels ou les publications originales.