Efficacité d'un Programme d'ETP Dans la myasthénie : étude de Preuve de Principe (MY-EDUC).
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 62
- 主要终点
- Perceived stress
研究概览
简要总结
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:
- Focus groups: exploration of beliefs associated with stress in myasthenia gravis.
- 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.
详细描述
- Background and Rationale Myasthenia Gravis (MG) is a rare autoimmune disorder of the neuromuscular junction (ORPHA 589), characterised by its chronic nature and the occurrence of fluctuating symptoms or flare-ups. Beyond the physical manifestations, the condition has a major impact on patients' quality of life. Recent data suggest that approximately 46.3% of patients suffer from anxiety disorders. While a Therapeutic Patient Education (TPE) programme entitled "Living better with myasthenia" is already established at Grenoble University Hospital, patients have expressed a clear requirement for specific modules addressing stress and anxiety management.
The MY-EDUC programme aims to adapt the current TPE framework by integrating a stress management module based on Cognitive Behavioural Stress Management (CBSM). CBSM has proven effectiveness in various chronic pathologies for improving treatment adherence, quality of life, and coping strategies. 2. Objectives Primary Objective: To evaluate the adaptation of the existing TPE programme after incorporating a CBSM-based stress management module (8 sessions) for adult patients with myasthenia gravis.
Secondary Objectives: To assess the feasibility and acceptability of the MY-EDUC programme. 3. Study Design and Methodology
This is an observational, prospective, descriptive, and monocentric study (classified as RIPH3 under French regulations). The research is conducted in three phases:
Phase 1 (Focus Groups): Exploration of stress-related beliefs with both expert patients and regular patients to adapt the session content.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is aged 18 years or over (legal age of majority under French law).
- •Participant has freely provided their non-opposition to participate in the study.
- •Participant has a confirmed diagnosis of Myasthenia Gravis.
- •Participant has sufficient proficiency in both spoken and written French to complete assessments and questionnaires, attend the programme sessions, and carry out home-based exercises.
排除标准
- •Participant presenting with one or more severe and established psychiatric disorders (e.g. severe depression, psychosis) that could interfere with the study's conduct, particularly the assessment of the primary and secondary endpoints.
- •Participant presenting with another chronic condition that induces fatigue. Protected persons (as defined by Articles L1121-5 to L1121-8 of the French Public Health Code [CSP]).
研究组 & 干预措施
MY-EDUC
Adults living with myasthenia gravis
干预措施: CBSM (Behavioral)
结局指标
主要结局
Perceived stress
时间窗: T0: Initial assessment at least 7 days before intervention. T2: After intervention assessment (maximum 7 days after intervention). 73: Maintenance effect (4 weeks after the end of the intervention).
The Perceived Stress Scale (PSS), developed by Cohen et al. (1983), is a widely established psychological instrument designed to measure the degree to which situations in an individual's life are appraised as stressful. Rather than focusing on objective life events, it assesses the extent to which respondents find their lives unpredictable, uncontrollable, and overloaded. This study utilises the PSS-10, a 10-item version refined for its robust psychometric properties. Participants rate items on a five-point Likert scale (0 = Never to 4 = Very Often) based on their feelings and thoughts during the last month. Total scores range from 0 to 40, with higher values indicating greater perceived stress. The PSS is favoured in clinical trials for its brevity, high internal consistency, and sensitivity to change, providing a reliable measure of psychological distress and the effectiveness of behavioural stress management interventions.
Anxiety
时间窗: T0: Initial assessment at least 7 days before intervention. T2: After intervention assessment (maximum 7 days after intervention). 73: Maintenance effect (4 weeks after the end of the intervention).
The Hospital Anxiety and Depression Scale (HADS), developed by Zigmond and Snaith (1983), is a validated 14-item self-report tool used to screen for anxiety and depression in clinical populations. It consists of two 7-item subscales: HADS-Anxiety (HADS-A) and HADS-Depression (HADS-D). A significant advantage of the HADS is its exclusion of somatic symptoms, such as fatigue or sleep disturbance, which may be symptoms of physical conditions like Myasthenia Gravis rather than psychological distress. This prevents the overestimation of emotional disorders in medically ill patients. Items are rated on a 4-point Likert scale (0-3), with subscale scores ranging from 0 to 21. Typically, scores of 0-7 are considered normal, 8-10 indicate borderline cases, and 11-21 suggest a probable clinical disorder. Its high internal consistency and sensitivity to therapeutic change make it a robust metric for evaluating the psychological impact of the MY-EDUC intervention.
Depression
时间窗: T0: Initial assessment at least 7 days before intervention. T2: After intervention assessment (maximum 7 days after intervention). 73: Maintenance effect (4 weeks after the end of the intervention).
The Hospital Anxiety and Depression Scale (HADS), developed by Zigmond and Snaith (1983), is a validated 14-item self-report tool used to screen for anxiety and depression in clinical populations. It consists of two 7-item subscales: HADS-Anxiety (HADS-A) and HADS-Depression (HADS-D). A significant advantage of the HADS is its exclusion of somatic symptoms, such as fatigue or sleep disturbance, which may be symptoms of physical conditions like Myasthenia Gravis rather than psychological distress. This prevents the overestimation of emotional disorders in medically ill patients. Items are rated on a 4-point Likert scale (0-3), with subscale scores ranging from 0 to 21. Typically, scores of 0-7 are considered normal, 8-10 indicate borderline cases, and 11-21 suggest a probable clinical disorder. Its high internal consistency and sensitivity to therapeutic change make it a robust metric for evaluating the psychological impact of the MY-EDUC intervention.
次要结局
- Health-related Quality of Life(T0: Initial assessment at least 7 days before intervention. T2: After intervention assessment (maximum 7 days after intervention). 73: Maintenance effect (4 weeks after the end of the intervention).)