Personalized treatment and telemedicine support for Multiple System Atrophy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical study evaluates the effects of a personalized symptomatic treatment plan combined with monthly telemedicine and mobile palliative care interventions for individuals diagnosed with Multiple System Atrophy (MSA) and their informal caregivers. A total of 46 patients will receive a tailored therapeutic plan that includes medical treatment, physiotherapy, psychological support, and social work assistance. Participants will be assessed at baseline and re-evaluated at 6, 12, and 18 months to measure changes in quality of life. The study aims to enhance the support provided to patients and caregivers throughout the progression of the disease.

Why it matters

Who can join: the full rules

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.

Where it's running

• Innsbruck Medical University
  Innsbruck, Austria, Austria Recruiting

Study contacts

• Principal investigator: Alessandra Fanciulli, MD PhD — Medical University Innsbruck
• Study coordinator: Alessandra Fanciulli, MD PhD
• Email: alessandra.fanciulli@i-med.ac.at
• Phone: +4351250483238

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.