Actively Recruiting

Phase Not Applicable
Age: 30Years +
All Genders
NCT06072105

Medical Decision Making in Multiple System Atrophy

Led by Medical University Innsbruck · Updated on 2025-02-05

92

Participants Needed

1

Research Sites

204 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Medical Decision Making in Multiple System Atrophy

Who Can Participate

Age: 30Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 30 years or older at the time of consent
  • Diagnosed with clinically probable or clinically established Multiple System Atrophy
  • Life expectancy of at least 24 months as assessed by the investigator
  • Understands and agrees to comply with study procedures and provides written informed consent personally
  • Signed and dated informed consent document
  • Fluency in German
  • If unable to walk or stand without assistance at consent, lives in Tyrol or another Austrian region with mobile palliative care available
  • Informal caregiver of an individual with MSA recruited in this study
  • Informal caregivers aged 18 years or older
  • Caregivers understand and agree to provide information and participate in online interviews
  • Caregivers provide signed and dated written informed consent
  • Caregivers have full legal capacity
  • Caregivers are fluent in German
Not Eligible

You will not qualify if you...

  • Participation in an interventional clinical study that interferes with the personalized treatment plan or telemedicine and mobile palliative care
  • Charlson comorbidity index greater than 4 at the time of consent
  • Other major medical conditions that may affect study results as assessed by the investigator

AI-Screening

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Trial Site Locations

Total: 1 location

1

Innsbruck Medical University

Innsbruck, Austria, Austria, 6020

Actively Recruiting

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Research Team

A

Alessandra Fanciulli, MD PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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