NCT01711606终止不适用
EXPLAIN - FragilE X Registry: An exPlorative Longitudinal Study for chAracterIzation, Treatment Pathways and patieNt-related Outcomes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Patient characteristics (demographics, family history, comorbidities, education, working situation, care situation, insurance status)
研究概览
简要总结
This prospective observational study (registry) on Fragile X syndrome (FXS) is designed to evaluate characteristics, management and patient and caregiver-related outcomes the quality of life of Families and patients with FXS and to collect epidemiological and health economic data.
- EXPLAIN will report current and comprehensive data onEpidemiology data on fragile X syndrome
- Characterisation of the phenotype of FXS patients
- Description of patient characteristics (demographics, family history, comorbidity, education, working situations, care situations, insurance status)
- Documentation of therapeutic interventions
- Recording and assessment of psychosocial parameters (possibly also inclusion of family members, carers)
- quality of life of the carer and if possible the patient
- Health economic parameters and consumption of resources
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with FXS as confirmed by genetic testing
排除标准
- •Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
Patient characteristics (demographics, family history, comorbidities, education, working situation, care situation, insurance status)
时间窗: 3 years
次要结局
- Therapeutic interventions and their application rationale(3 Years)
- Quality of life of the caregiver and possibly the patient(3 years)
- Health-economic parameters and consumption of resources(3 years)
- Psychosocial parameters (poss. also inclusion of family members, caregivers)(3 years)
- Epidemiology data on Fragile X Syndrome (FXS)(3 years)
研究者
研究点 (1)
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