Multidisciplinary and Personalized Care of Behavioral Disorders in Frontotemporal Lobar Degeneration.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Neuropsychiatric Inventory (NPI)
研究概览
简要总结
Fronto-Temporal Lobar Degeneration (FTLD) refers to 3 categories of neurodegenerative diseases generally occurring between 55 and 65 years: Fronto-Temporal Dementia(FTD), Primary Progressive Aphasia (PPA), Semantic Dementia (SD). Clinical expression is substantially variable among individuals, but in most cases, behavioural disorders and personality changes are prominent. FTLD is poorly known by general public including health care professionals. Currently, the French health system does not meet the needs and expectations of patients and their families
详细描述
Patients with FTLD and their caregivers need to be recognized and supported through specific and tailored made actions provided by expert teams. The main objective of our study is to evaluate the effectiveness of a 6-month personalized multidisciplinary care provided to the dyad FTLD patient and caregiver on patient's behavioural disorders. The secondary objectives are to assess the impact of this program on patient's cognitive deterioration, functional autonomy and behavioral problems, as well as caregiver's depressive symptomatology and sense of competence
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fronto-Temporal Lobar Degeneration diagnoses
- •Men or women aged 18 and over
- •Spouse, brother, sister, child living at patient's home and can provide the medical team of reliable information on the status of their parent.
排除标准
- •Patient institutionalized
- •Pregnant or breast-feeding woman
- •Psychotic syndrome
- •Severe and unstable general medical condition
- •Patient bedridden
- •Persons under legal protection
- •Severe and unstable general medical condition
- •Pregnant or breast-feeding woman
结局指标
主要结局
Neuropsychiatric Inventory (NPI)
时间窗: 6 months
Assessment of neuropsychiatric symptomatology
次要结局
- Neuropsychiatric Inventory (NPI)(12 months)
- Frontal Behavioral Inventory(6 months and 12 months)
- Mini Mental State Examination(6 months and 12 months)
- Frontal Assessment Battery(6 months and 12 months)
- Geriatric Depression Scale Score ( From 0 to 30)(6 months and 12 months)
- Sense of Competence Questionnaire (SCQ)(6 months and 12 months)
- Hierarchical scale of internality for elderly people (EHIPA) score ( From 0 to 22)(6 months and 12 months)
- Quality of Life Questionnaire (QoL-AD)(6 months and 12 months)