Medical Decision Making in Multiple System Atrophy
- Sponsor
- Medical University Innsbruck
- Study ID
- NCT06072105
- Status
- Recruiting
Conditions
- Multiple System Atrophy
Eligibility Criteria
- Sex
- ALL
- Age
- 30 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Telemedicine visits — OTHERMonthly telemedicine neurological, psychological and neurorehabilitation (physio-, occupational and speech therapy) consultations
- Multidisciplinary, personalized symptomatic treatment — OTHERMultidisciplinary, personalized symptomatic treatment plus mobile palliative care interventions (if wished and needed)
Study Details
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 Dates
- First listed
- Oct 10, 2023
- Start date
- Oct 1, 2023
- Status verified
- Feb 2025
- Primary completion
- Sep 30, 2027
- Completion
- Sep 30, 2027
Study Design
- Enrollment
- 92 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Active Comparator: Group 1Personalized best medical care.
- Experimental: Group 2Personalized best medical care PLUS telemedicine
Primary Outcome Measure
Change in the EQ-5D-5L score [ Time Frame: Baseline to 18-months ]
Central Contacts
- Alessandra Fanciulli, MD PhD+4351250483238
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