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Medical Decision Making in Multiple System Atrophy (MeDeMSA)

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ClinicalTrials.gov Identifier: NCT06072105
Recruitment Status : Recruiting
First Posted : October 10, 2023
Last Update Posted : October 10, 2023
Sponsor:
Information provided by (Responsible Party):
Alessandra Fanciulli, Medical University Innsbruck

Study Description
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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.


Condition or disease Intervention/treatment Phase
Multiple System Atrophy Other: Telemedicine visits Other: Multidisciplinary, personalized symptomatic treatment Not Applicable

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. 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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: 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
Estimated Study Start Date : October 2023
Estimated Primary Completion Date : September 2027
Estimated Study Completion Date : September 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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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: Telemedicine visits
Monthly telemedicine neurological, psychological and neurorehabilitation (physio-, occupational and speech therapy) consultations

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


Outcome Measures
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Primary Outcome Measures :
  1. Change in the EQ-5D-5L score [ Time Frame: Baseline to 18-months ]
    Assessment of improvement of the patient´s quality of life


Secondary Outcome Measures :
  1. Changes in the MSA-QoL score and subscores [ Time Frame: Baseline to 6-, 12- and 18-months ]
    Assessment of improvement of the quality of life, specifically designed for people with MSA

  2. 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 motor score and Hoehn & Yahr changes over the study period.

  3. 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.

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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)

  10. Single-intervention and cumulative healthcare costs [ Time Frame: over the 18-months study period ]
    Record of healthcare costs

  11. 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 ]
    Assessment of improvement of caregivers´quality of life

  12. 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 ]
    Assessment of improvement of caregivers´quality of life specifically designed for the caregivers of individuals diagnosed with Parkinsonisms


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

For individuals with MSA:

i. Age ≥30 years at the time of consent; ii. Diagnosed with clinically probable or clinically established MSA according to the current MDS MSA criteria (1); iii. Life-expectancy of at least 24 months as assessed by the investigator at the time of consent; iv. 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); v. Signed and dated informed consent document; vi. Fluency in German; vii. Living in Tyrol, if not able to walk or stand without assistance/support at the time of consent.

For informal caregivers:

i. Informal caregiver (i.e. person not receiving payment for his/her caregiving) of an individual with MSA recruited in the present study; ii. Life-expectancy of at least 24 months as assessed by the investigator at the time of consent; iii. Age≥ 18 years at the time of consent; iv. Understands and agrees to provide information as outlined in the study protocol and to engage in semi-structured online interviews; v. Provides signed and dated written informed consent; vi. Full legal capacity; vii. Fluency in German.

Exclusion Criteria

For individuals with MSA i. 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; ii. Charlson comorbidity index >4 at the time of consent; iii. Other major underlying medical conditions that may confound interpretation of study results as assessed by the investigator.

Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06072105


Contacts
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Contact: Alessandra Fanciulli, MD PhD +4351250483238 alessandra.fanciulli@i-med.ac.at

Locations
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Austria
Innsbruck Medical University Recruiting
Innsbruck, Austria, 6020
Contact: Alessandra Fanciulli, MD PhD    +4351250483238    alessandra.fanciulli@i-med.ac.at   
Sponsors and Collaborators
Medical University Innsbruck
Investigators
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Principal Investigator: Alessandra Fanciulli, MD PhD Medizinische Universität Innsbruck
More Information
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Publications:

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Responsible Party: Alessandra Fanciulli, Assist. Prof. MD PhD, Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT06072105    
Other Study ID Numbers: 1225/2023
First Posted: October 10, 2023    Key Record Dates
Last Update Posted: October 10, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alessandra Fanciulli, Medical University Innsbruck:
MSA
Movement disorders
Autonomic dysfunctions
 Telemedicine
Palliative care
Caregivers burden
Additional relevant MeSH terms:
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Multiple System Atrophy
Shy-Drager Syndrome
Atrophy
Pathological Conditions, Anatomical
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Basal Ganglia Diseases
 Brain Diseases
Central Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Hypotension
Vascular Diseases
Cardiovascular Diseases