Medical Decision Making in Multiple System Atrophy

Recruiting now · Not applicable

Conditions studied: Multiple System Atrophy

In brief

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 individuals diagnosed with Multiple System Atrophy (MSA) and their informal caregivers. The aim is to improve the quality of life of MSA patients and their caregivers, as well as provide them with better support during the disease progression. After a baseline visit, all 46 patients will receive a personalized therapeutic plan (including medical treatment, physiotherapy, logotherapy and occupational therapy excercises and psychological support) and contact with social workers and a palliative care team. They willl then be re-evaluated at 6-,12-, 18- month visits. Semi-structured online interviews at baseline and 12 month visit will collect patients' individual healthcare preferences, which will be taken into account in the preparation of the individual therapeutic plan. Twenty-three patients will be randomized to receive monthly telemedicine visits. Assessment of patients´satisfaction with the therapeutic plan, with the palliative interventions (when they occurred) and the telemedicine visits will be carried over the 18 month period. Forty-six informal caregivers will be invited to participate with semi-structured online interviews and assessment of their QoL and caregivers' burden.

Key facts

Study ID

NCT06072105

Run by

Medical University Innsbruck

People needed

92

Starts

2023-10-01

Expected to finish

2027-09-01

Last updated by the study team

2025-02-05

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Innsbruck Medical University — Innsbruck, Austria, Austria (enrolling)

Full record on ClinicalTrials.gov

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