Cognitive Functioning in People With Myasthenia Graivs: Impact on Daily Life Activities, Work, Disability and Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- GEMS
研究概览
简要总结
MYCOG primarily aims to estimate the prevalence of cognitive difficulties in patients with MG treated at Besta Institute. Secondary aims include: a) assess the degree to which cognitive difficulties are associated to work impairment, limitations in ADL, symptoms of anxiety and depression, fatigue, disability and QoL; b) assess whether patients with different MG types show different degrees of cognitive impairment; c) assess whether patients with different MG antibody profiles show different degrees of cognitive impairment; d) assess whether patients under different MG-specific pharmacological treatments show different degrees of cognitive impairment.
详细描述
Previous literature findings provide contradictory indications about presence of cognitive impairment in patients with MG, but patients experience different degree of limitations in ADLs, disability and QoL which might not be entirely understood on the basis of neuromuscular symptoms. We therefore aimed to address the potential impact of cognitive impairment.
MYCOG is a monocentric, cross-sectional and observational study which primarily aims to estimate the prevalence of cognitive difficulties, measured with Global Examination of Mental State (GEMS), in patients with MG treated at Besta Institute. Secondary aims include: a) assess the degree to which cognitive difficulties are associated to work impairment (measured with WPAI-GH), limitations in ADL (measured with MG-ADL), symptoms of anxiety and depression (measured with HADS), fatigue (measured with FSS), disability and QoL (measured with MG-DIS and MG-QOL15); b) assess whether patients with different MG types (ocular, generalized, bulbar, pharmacological remission and clinical stable remission) show different degrees of cognitive impairment; c) assess whether patients with different MG antibody profiles (AChR, MuSK, Double Negative) show different degrees of cognitive impairment; d) assess whether patients under different MG-specific pharmacological treatments (piridogstigmine, steroids, other therapies such as immunemodulators) show different degrees of cognitive impairment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with MG,
- •followed-up at Besta institute
- •aged 18-99,
- •able to understand Italian language;
排除标准
- •psychiatric comorbidies of psychotic nature;
- •do not accept to participate on a voluntary basis;
- •patients who should be excluded based on physician's judgement;
- •patients who live in a nursing home for aged or disabled persons;
- •respiratory impairment (patients under mechanical ventilation)
结局指标
主要结局
GEMS
时间窗: 22 months
Global examination of cognitive functioning
次要结局
- CRIq(22 months)
- ENB-3(22 months)
- MG-DIS(22 months)
- MG-QOL15(22 months)
- MG-ADL(22 months)
- WPAI-GH(22 months)
- HADS(22 months)
- FSS(22 months)
- CCI(22 months)
- Clinical profile(22 months)
