CompletedNot Applicable

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

United States411 participantsStarted 2021-01-18

Plain-language 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.

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

What they're measuring

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)

Timeframe: Baseline

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

Timeframe: Baseline

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

Timeframe: Baseline

Responses to bespoke questionnaire describing the emotional burden on family members

Timeframe: Baseline

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

Timeframe: Baseline

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

Timeframe: Baseline

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

Timeframe: Baseline

Trial details

NCT IDNCT04665323

SponsorIpsen

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-04-30

View on ClinicalTrials.gov More Fibrodysplasia Ossificans Progressiva trials

Plain-language summary

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

What they're measuring

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)

Timeframe: Baseline

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

Timeframe: Baseline

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

Timeframe: Baseline

Responses to bespoke questionnaire describing the emotional burden on family members

Timeframe: Baseline

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

Timeframe: Baseline

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

Timeframe: Baseline

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

Timeframe: Baseline