Fibrodysplasia Ossificans Progressiva
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Ipsen
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. 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 2. All adult participants and parents / legal guardians of minors should provide informed consent before starting filling out the survey
Exclusion criteria
1\. Any individuals who are unable to complete the online survey independently or to get assistance to physically enter the answers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | Baseline |
| Quality of life of people living with FOP and their family members, measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) | Baseline |
| Caregiver burden for the parent primary caregiver, measured using the Zarit Burden Interview (ZBI) | Baseline |
| Responses to bespoke questionnaire describing the emotional burden on family members | Baseline |
| Physical function of the person living with FOP, measured using the FOP Physical Function Questionnaire (FOP-PFQ). | Baseline |
| Joint function of the person living with FOP, measured using Patient-Reported Mobility Assessment (PRMA). | Baseline |
| Responses to bespoke questionnaire describing the types of healthcare services utilized by the person living with FOP over the last two years | Baseline |
| Responses to bespoke questionnaire describing the frequency of utilization of healthcare services by the person living with FOP over the last two years. | Baseline |
| Responses to bespoke questionnaire describing the impact of FOP on modifications to the living environment (e.g. home modifications) and travels. | Baseline |
| Responses to bespoke questionnaire describing the expenses paid by the family for the care of the person living with FOP | 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 | Baseline |
Countries
United States
Outcome results
None listed