Patient-reported, Health Economic and Psychosocial Outcomes in Friedreich Ataxia

Status: Recruiting
Location: See all (6) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Austria
Klinik für Neurologie, Medizinische Universität Innsbruck
RECRUITING
Innsbruck
France
Paris Brain Institute
RECRUITING
Paris
Germany
Department of Neurology, RWTH Aachen University
RECRUITING
Aachen
German Center for Neuro-degenerative Diseases (DZNE)
RECRUITING
Bonn
Friedrich-Baur-Institut an der Neurologischen Klinik und Poliklinik
RECRUITING
Münich
Neurologische Klinik und Hertie-Institut für Klinische Hirnforschung, Universitätsklinik Tübingen
NOT_YET_RECRUITING
Tübingen
Contact Information
Primary
Bernhard Michalowsky, PD Dr.
bernhard.michalowsky@dzne.de
+49 3834 868530
Backup
Maresa Buchholz, Dr.
maresa.buchholz@dzne.de
+49 3834 868534
Time Frame
Start Date: 2023-06-01
Estimated Completion Date: 2024-10-31
Participants
Target number of participants: 200
Sponsors
Collaborators: Sorbonne University, McMaster University
Leads: German Center for Neurodegenerative Diseases (DZNE)

This content was sourced from clinicaltrials.gov