Patient-reported, Health Economic and Psychosocial Outcomes in Friedreich Ataxia
German Center for Neurodegenerative Diseases (DZNE)
200 participants
Jun 1, 2023
OBSERVATIONAL
Conditions
Summary
The PROFA study is an international, multi-centric observational and validation study to assess the patient-reported, psychosocial and economic outcomes of patients with Friedreich Ataxia (FA). Eligible patients will be recruited from six study centers in Germany, Austria and France. Patients will complete a baseline assessment via face-to-face interviews at the study centers and multiple momentary follow-up assessments via a mobile-health app at home daily to monthly for six months. Study results will gain essential and in-depth insights into the daily life of patients with FA.
Eligibility
Inclusion Criteria4
- FA confirmed by molecular genetic testing
- Ataxia severity of ≤30 points according to the Scale of the Assessment and Rating of Ataxia (SARA)
- Access to a smartphone or tablet and able to operate the device
- Older than 12 years
Exclusion Criteria2
- Lack of ability to give consent
- Ataxia severity \>30 according to the Scale of the Assessment and Rating of Ataxia (SARA)
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Locations(6)
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NCT05943002