An International Cross-sectional Survey to Evaluate the Burden of Fibrodysplasia Ossificans Progressiva (FOP) on Patients and Their Families.

Ipsen411 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

411

Conditions

Fibrodysplasia Ossificans Progressiva

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Ipsen Central Contact

Cambridge, Massachusetts, United States

Outcomes

Primary Outcomes

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)

Time frame: Baseline

Quality of life of people living with FOP and their family members, measured using the Patient-Reported Outcomes Measurement Information System (PROMIS)

Time frame: Baseline

Caregiver burden for the parent primary caregiver, measured using the Zarit Burden Interview (ZBI)

Time frame: Baseline

Responses to bespoke questionnaire describing the emotional burden on family members

Time frame: Baseline

Physical function of the person living with FOP, measured using the FOP Physical Function Questionnaire (FOP-PFQ).

Time frame: Baseline

Joint function of the person living with FOP, measured using Patient-Reported Mobility Assessment (PRMA).

Time frame: Baseline

Responses to bespoke questionnaire describing the types of healthcare services utilized by the person living with FOP over the last two years

Time frame: Baseline

Responses to bespoke questionnaire describing the frequency of utilization of healthcare services by the person living with FOP over the last two years.

Time frame: Baseline

Responses to bespoke questionnaire describing the impact of FOP on modifications to the living environment (e.g. home modifications) and travels.

Time frame: Baseline

Responses to bespoke questionnaire describing the expenses paid by the family for the care of the person living with FOP

Data from ClinicalTrials.gov

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