An International Cross-sectional Survey to Evaluate the Burden of Fibrodysplasia Ossificans Progressiva (FOP) on Patients and Their Families.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 411
- 试验地点
- 1
- 主要终点
- Quality of life of people living with FOP and their family members, measured using the EuroQol health-related quality of life (QoL) questionnaire (EQ-5D-5L)
研究概览
简要总结
The FOP burden of illness (BoI) survey aims to assess the impact of the burden of FOP on patients and their families. The study is being conducted online and available for residents in Argentina, Brazil, Canada, France, Germany, Italy, Japan, Mexico, Poland, Russia, South Korea, Spain, Sweden, the US, and the UK.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Individuals meeting one of the two categories below (A or B) are eligible to participate: A. Any individual with FOP, of any age; B. Any individual who is a family member of a person with FOP (i.e. either a parent / legal guardian or a sibling) and who is aged 18 years and older
- •All adult participants and parents / legal guardians of minors should provide informed consent before starting filling out the survey
排除标准
- •Any individuals who are unable to complete the online survey independently or to get assistance to physically enter the answers
结局指标
主要结局
Quality of life of people living with FOP and their family members, measured using the EuroQol health-related quality of life (QoL) questionnaire (EQ-5D-5L)
时间窗: Baseline
Quality of life of people living with FOP and their family members, measured using the Patient-Reported Outcomes Measurement Information System (PROMIS)
时间窗: Baseline
Caregiver burden for the parent primary caregiver, measured using the Zarit Burden Interview (ZBI)
时间窗: Baseline
Responses to bespoke questionnaire describing the emotional burden on family members
时间窗: Baseline
Physical function of the person living with FOP, measured using the FOP Physical Function Questionnaire (FOP-PFQ).
时间窗: Baseline
Joint function of the person living with FOP, measured using Patient-Reported Mobility Assessment (PRMA).
时间窗: Baseline
Responses to bespoke questionnaire describing the types of healthcare services utilized by the person living with FOP over the last two years
时间窗: Baseline
Responses to bespoke questionnaire describing the frequency of utilization of healthcare services by the person living with FOP over the last two years.
时间窗: Baseline
Responses to bespoke questionnaire describing the impact of FOP on modifications to the living environment (e.g. home modifications) and travels.
时间窗: Baseline
Responses to bespoke questionnaire describing the expenses paid by the family for the care of the person living with FOP
时间窗: Baseline
Responses to bespoke questionnaire describing the Impact of FOP on education, employment, and career choices for people living with FOP and their family members
时间窗: Baseline
次要结局
未报告次要终点