Medical Decision Making in Multiple System Atrophy (MeDeMSA)

February 3, 2025 updated by: Alessandra Fanciulli, Medical University Innsbruck

Medical Decision Making in Multiple System Atrophy: Developing Personalized Best Medical Care with Integrated Telemedicine and Mobile Palliative Care for Individuals with Multiple System Atrophy

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a monocentric, 18-months, randomized, rater-blinded study to evaluate the influence of a multidisciplinary, personalized symptomatic treatment plan with integrated mobile palliative care and telemedicine on the baseline to 18-months change in the QoL of individuals with MSA compared to a sex-, age- and disease-duration matched historical European MSA cohort, whose data is stored at the Medical University of Innsbruck.

We plan to recruit 46 individuals with MSA fulfilling all the inclusionand none of the exclusion criteria. Upon collection of written informed consent, the recruited individuals will be instructed to complete a falls protocol referred to the month preceding the baseline visit, as well as a blood pressure (BP), bladder diary for up to 72 hours prior to the baseline visit. They will subsequently undergo a baseline examination including a comprehensive clinical, psychological and neuro-rehabilitation assessment, as well as an online semi-structured interview aimed at pinpointing the individual therapeutic needs and healthcare preferences. In case additional examinations are needed, these will be carried out on the same day of the baseline visit or, if not possible for individual or appointment reasons, at the earliest possible time point within the given timeframe as outlined in the visit schedule. Upon completion of the baseline visit and examinations, the individualized therapeutic plan, including mobile palliative care offer (for wheelchair-bound individuals) and guidance for self-practiced physio-, speech and occupational exercises will be prepared based on a standardized operational protocol drafted by the study team on the basis of published consensus recommendations, scientific evidence and principles of good clinical practice and adapted to the individual healthcare preferences and therapeutic needs of the recruited individuals.

Six, 12 and 18 months after the baseline visit, in-person visits will be scheduled, including a comprehensive clinical, psychological and neuro-rehabilitation re-assessment of the individual therapeutic needs. Therapeutic adaptations will be made following the standardized operational protocol and adapted to the individual healthcare preferences. In the event that the enrolled subjects are for legitimate reasons unable to travel to hospital, they will be offered the opportunity to complete the scheduled on-site assessments of month 6, 12, and 18 using the CHES online platform.

At month 12 the online semi-structured interview will be repeated to assess for eventual changes in the individual healthcare preferences due to the disease progression.

At month 1, 7 and 13, follow-up phone calls will be scheduled to verify the compliance with the individualized treatment plan and identify barriers to its application.

At month 1, 7, 13 and 18, the study participants will be invited to complete online satisfaction surveys with the overall individualized treatment plan.

Twenty-three patients will be block-wise randomized to receive additional monthly and on-demand neurological, psychological, physio-, occupational and speech therapy (based on individual needs) telemedicine visits through the CHES teleconsultation facility of the Tirol Kliniken.

Upon completion of the telemedicine visit (or on-demand mobile palliative interventions, for wheelchair-bound individuals, whenever needed and wished), brief satisfaction surveys will be sent to the study participants through the CHES platform.

Informal caregivers of the individuals with MSA recruited in the present study will be invited to participate upon written informed consent in an 18 months observational study, with baseline and 12 months semi-structured online interviews and baseline, 6-, 12- and 18 months assessment of their QoL and caregivers' burden.

Study Type

Interventional

Enrollment (Estimated)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
Personalized best medical care.
Other: Multidisciplinary, personalized symptomatic treatment
Multidisciplinary, personalized symptomatic treatment plus mobile palliative care interventions (if wished and needed)
Experimental: Group 2
Personalized best medical care PLUS telemedicine
Other: Multidisciplinary, personalized symptomatic treatment
Multidisciplinary, personalized symptomatic treatment plus mobile palliative care interventions (if wished and needed)
Other: Telemedicine visits
Monthly telemedicine neurological, psychological and neurorehabilitation (physio-, occupational and speech therapy) consultations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the EQ-5D-5L score
Time Frame: Baseline to 18-months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to clinical milestones
Time Frame: over the 18-months study period
The clinical milestones are falls at least once a day, feeding by nasogastric tube or gastrostomy, unintelligible speech, indwelling catheter, wheelchair dependency.
over the 18-months study period
Changes in the individual healthcare preferences assessed by means of the Autonomy Preference Index (API)
Time Frame: Baseline to 12- months
Assessment of individual preferences about the individual healthcare
Baseline to 12- months
In-person and telemedicine medical, psychological and neurorehabilitation interventional needs of individuals with MSA
Time Frame: over the 18-months study period
Registration of the need of support required by MSA patients
over the 18-months study period
Change in the Short Assessment of Patient Satisfaction (SAPS) referred to the overall individualized treatment plan
Time Frame: Month 1 to 7, 13 and 18
Assessment of patients´ level of satisfaction with the individuaized treatment plan
Month 1 to 7, 13 and 18
Individual satisfaction with the single telemedicine and mobile palliative interventions
Time Frame: over the 18-months study period
The individual satisfaction will be assessed by means of online numeric rating scales and open-ended questions
over the 18-months study period
Healthcare professionals satisfaction with the single telemedicine and mobile palliative interventions
Time Frame: over the 18-months study period
The individual healthcare professionals satisfaction will be assessed by means of online numeric rating scales and open-ended questions
over the 18-months study period
Number of medical complications
Time Frame: over the 18-months study period
Record of number of medical complications occurred (e.g. falls with or w/o injuries, urinary tract infections, choking, aspiration pneumonia, hospitalizations, death, others)
over the 18-months study period
Single-intervention and cumulative healthcare costs
Time Frame: over the 18-months study period
Record of healthcare costs
over the 18-months study period
Changes in the MSA-QoL score and subscores
Time Frame: Baseline to 6-, 12- and 18-months
The Multiple System Atrophy - Quality of Life,is a questionnaire composed of 40 items investigating several MSA-specific motor and non-motor symptoms, as well as their perceived impact on daily life and a numeric rating scale to assess the QoL of individuals diagnosed with MSA. Scores on each of the subscales of the MSA are derived by summing the respective items and transforming to a range of 0-100, with higher scores on each scale indicating a higher impact of the disease on the aspect measured by each subscale.
Baseline to 6-, 12- and 18-months
Change in motor and non-motor scales
Time Frame: Baseline to 6-, 12- and 18-months
It includes total and subscores, as video-based, rater-blinded assessment of the UMSARS (Unified Multiple System Atrophy Rating Scale) motor score and Hoehn & Yahr changes over the study period. In both the scales a higher score is related to a higher impact of the disease on the aspect measured.
Baseline to 6-, 12- and 18-months
Changes in the EQ-5D-5L score of informal caregivers of individuals with MSA recruited in the present study
Time Frame: Baseline to 6-, 12- and 18-months
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 6-, 12- and 18-months
Change in the Carers quality-of-life questionnaire for parkinsonism (PQoL Carers) score and other caregiver-burden indicators in informal caregivers of individuals with MSA recruited in the present study
Time Frame: Baseline to 6-, 12- and 18-months
The Parkinsonism Carers Quality of Life, is a questionnaire composed of 26 items and is a concise instrument with adequate psychometric qualities to assess the QoL of the caregivers of people with atypical Parkinsonism. A score of 0 indicates the best level of QoL, whereas a score of 100 the worst level.
Baseline to 6-, 12- and 18-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University Innsbruck

Investigators

  • Principal Investigator: Alessandra Fanciulli, MD PhD, Medizinische Universitat Innsbruck

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

October 2, 2023

First Submitted That Met QC Criteria

October 2, 2023

First Posted (Actual)

October 10, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 3, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1225/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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