Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-25 @ 3:31 AM
NCT ID:
NCT06072105
Eligibility Criteria:
Inclusion Criteria
For individuals with MSA:
* Age ≥30 years at the time of consent;
* Diagnosed with clinically probable or clinically established MSA according to the current MDS MSA criteria (1);
* Life-expectancy of at least 24 months as assessed by the investigator at the time of consent;
* Understands and agrees to comply with the study procedures and provides written informed consent (Note: a legal representative may NOT provide consent on behalf of the subject);
* Signed and dated informed consent document;
* Fluency in German;
* If not able to walk or stand without assistance/support at the time of consent, the participant lives in Tyrol or in another Austrian Region with available mobile palliative care.
For informal caregivers:
* Informal caregiver (i.e. person not receiving payment for his/her caregiving) of an individual with MSA recruited in the present study;
* Life-expectancy of at least 24 months as assessed by the investigator at the time of consent;
* Age≥ 18 years at the time of consent;
* Understands and agrees to provide information as outlined in the study protocol and to engage in semi-structured online interviews;
* Provides signed and dated written informed consent;
* Full legal capacity;
* Fluency in German.
Exclusion Criteria
For individuals with MSA
* Participation in an interventional clinical study at screening and throughout the study that would interfere with the MeDeMSA Care personalized treatment plan or would not permit telemedicine and mobile palliative care strategies;
* Charlson comorbidity index \>4 at the time of consent;
* Other major underlying medical conditions that may confound interpretation of study results as assessed by the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Study:
NCT06072105
Study Brief:
Protocol Section:
NCT06072105