NCT06072105 Medical Decision Making in Multiple System Atrophy
| NCT ID | NCT06072105 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University Innsbruck |
| Condition | Multiple System Atrophy |
| Study Type | INTERVENTIONAL |
| Enrollment | 92 participants |
| Start Date | 2023-10-01 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 92 participants in total. It began in 2023-10-01 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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.
Contact & Investigator
Alessandra Fanciulli, MD PhD
PRINCIPAL INVESTIGATOR
Medical University Innsbruck
Frequently Asked Questions
Who can join the NCT06072105 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, studying Multiple System Atrophy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06072105 currently recruiting?
Yes, NCT06072105 is actively recruiting participants. Contact the research team at alessandra.fanciulli@i-med.ac.at for enrollment information.
Where is the NCT06072105 trial being conducted?
This trial is being conducted at Innsbruck, Austria.
Who is sponsoring the NCT06072105 clinical trial?
NCT06072105 is sponsored by Medical University Innsbruck. The principal investigator is Alessandra Fanciulli, MD PhD at Medical University Innsbruck. The trial plans to enroll 92 participants.