Medical Decision Making in Multiple System Atrophy

NCT06072105 | Recruiting

• 1 other identifier: 1225/2023
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple System Atrophy

Keywords

MSA; Movement disorders; Autonomic dysfunctions; Telemedicine; Palliative care; Caregivers burden

Outcome Measures

Primary Outcomes (1)

• Change in the EQ-5D-5L score

  European Quality of life - 5 Dimensions - 5 Levels. This is a 5 dimensions assessment of mobility, self-care, usual activities, pain/discomfort and anxiety/depression that provides a single summary index value for health status. It also includes the EQ-VAS, a self-rating of overall health on a visual analogue scale (VAS), ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). A summary index with a maximum score of 1 can be derived from the five dimensions of EQ-5D by conversion with a table of scores. The maximum score of 1 indicates the best health state, in contrast with the scores of individual questions, where higher scores indicate more severe or frequent problems.

  Baseline to 18-months

Secondary Outcomes (12)

• Changes in the MSA-QoL score and subscores

  Baseline to 6-, 12- and 18-months

• Change in motor and non-motor scales

  Baseline to 6-, 12- and 18-months

• Time to clinical milestones

  over the 18-months study period

• Changes in the individual healthcare preferences assessed by means of the Autonomy Preference Index (API)

  Baseline to 12- months

• In-person and telemedicine medical, psychological and neurorehabilitation interventional needs of individuals with MSA

  over the 18-months study period

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Personalized best medical care.

Other: Multidisciplinary, personalized symptomatic treatment

Group 2

EXPERIMENTAL

Personalized best medical care PLUS telemedicine

Other: Telemedicine visits; Other: Multidisciplinary, personalized symptomatic treatment

Interventions

Telemedicine visits OTHER

Monthly telemedicine neurological, psychological and neurorehabilitation (physio-, occupational and speech therapy) consultations

Group 2

Multidisciplinary, personalized symptomatic treatment OTHER

Multidisciplinary, personalized symptomatic treatment plus mobile palliative care interventions (if wished and needed)

Group 1; Group 2

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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;

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.

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (1)

Innsbruck Medical University

Innsbruck, Austria, 6020, Austria

RECRUITING

Related Publications (55)

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MeSH Terms

Conditions

Multiple System Atrophy; Movement Disorders

Condition Hierarchy (Ancestors)

Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Alessandra Fanciulli, MD PhD

  Medizinische Universität Innsbruck

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessandra Fanciulli, MD PhD

CONTACT

+4351250483238; alessandra.fanciulli@i-med.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. MD PhD

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: October 10, 2023
• Study Start: October 1, 2023
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)