Status:
RECRUITING
Medical Decision Making in Multiple System Atrophy
Lead Sponsor:
Medical University Innsbruck
Conditions:
Multiple System Atrophy
Eligibility:
All Genders
30+ years
Phase:
NA
Brief Summary
The goal of this clinical study is to evaluate the effects of a personalized symptomatic treatment plan integrated with monthly telemedicine and mobile palliative care interventions on a population of...
Detailed Description
This is a monocentric, 18-months, randomized, rater-blinded study to evaluate the influence of a multidisciplinary, personalized symptomatic treatment plan with integrated mobile palliative care and t...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT06072105
Start Date
October 1 2023
End Date
September 1 2027
Last Update
February 5 2025
Active Locations (1)
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1
Innsbruck Medical University
Innsbruck, Austria, Austria, 6020