ClinicalTrials.gov record NCT06072105
Medical Decision Making in Multiple System Atrophy
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
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Randomized, 18-month interventional study comparing a multidisciplinary, personalized symptomatic treatment plan with or without monthly telemedicine and optional mobile palliative care for people with Multiple System Atrophy and their informal caregivers. All patients receive an individualized care plan; half are randomized to receive additional monthly telemedicine consultations. Caregivers are invited to interviews and quality-of-life and caregiver-burden assessments. Key eligibility gates (brief): age ≥30, a clinical diagnosis of probable or established MSA, fluency in German, an investigator-estimated life expectancy ≥24 months; participants in other interventional trials that would interfere, a Charlson comorbidity index >4, or other major medical conditions are excluded.
What it is studying. This study tests whether adding monthly telemedicine visits (neurology, psychology, and neurorehabilitation) and optional mobile palliative care to a multidisciplinary, personalized symptomatic treatment plan changes patient- and caregiver-reported quality of life, satisfaction, clinical milestones, healthcare needs, complications, and costs over an 18-month period.
What the researchers hope to learn. Scientific goals: to measure changes in generic and MSA-specific quality-of-life scores (EQ-5D-5L and MSA-QoL), motor and non-motor scales, time to defined clinical milestones, individual healthcare preferences, needs for in-person versus telemedicine or mobile palliative support, patient and provider satisfaction with interventions, number of medical complications, and single-intervention and cumulative healthcare costs; and to assess caregiver quality of life and caregiver burden.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Other
- Telemedicine visits
- Multidisciplinary, personalized symptomatic treatment
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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 description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Show the detailed description from the registry
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.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Patients complete pre-baseline diaries (falls protocol, up to 72-hour blood pressure and bladder diaries) and attend a baseline visit with clinical, psychological and neuro-rehabilitation assessments and an online semi-structured interview about care preferences. Each patient receives an individualized multidisciplinary treatment plan (medical care, physiotherapy, speech/occupational exercises, psychological support and mobile palliative care if needed); half of patients (23 of 46) are randomized to receive additional monthly telemedicine consultations. Follow-up includes in-person reassessments at 6, 12 and 18 months (online assessments offered if travel is impossible), phone check-ins at months 1, 7 and 13, and online satisfaction surveys; brief satisfaction surveys follow telemedicine or mobile palliative visits. Informal caregivers invited to join will complete baseline and 12-month online interviews and caregiver quality-of-life and burden questionnaires at baseline, 6, 12 and 18 months.
How the study is structured. Interventional, randomized, parallel-group, rater-blinded study lasting 18 months. All enrolled patients receive a standardized, individualized multidisciplinary symptomatic care plan; half are randomly assigned to additional monthly telemedicine consultations and on-demand mobile palliative interventions when indicated. Participants have baseline and in-person reassessments at 6, 12, and 18 months (with online options if unable to travel), regular phone check-ins, and periodic online satisfaction surveys. Informal caregivers take part in an observational follow-up with interviews and repeated questionnaires.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The listed sites are in Austria. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on multiple system atrophy
Important dates
- Study start
- Oct 1, 2023
- Primary completion
- September 2027 (estimated)
- Study completion
- September 2027 (estimated)
- Target enrollment
- 92 participants (estimated)
- Last updated on registry
- Feb 5, 2025
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Medical University Innsbruck
- Principal investigator
- Alessandra Fanciulli, Assoc. Prof. MD PhD
Medical University Innsbruck
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Alessandra Fanciulli, MD PhD 📞 +4351250483238 ✉ alessandra.fanciulli@i-med.ac.at
Participating sites (1)
- Innsbruck Medical UniversityRecruiting
Innsbruck, Austria, 6020 · Austria
- Alessandra Fanciulli, MD PhD · +4351250483238 · alessandra.fanciulli@i-med.ac.at
Terms used on this page · explanations by MedicalUpdates.ai
- baseline
- Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
- randomized
- Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
- written informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- legal representative
- A person who is legally allowed to make decisions, including consent to research, on behalf of someone who cannot consent for themselves.
- at screening
- The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- blinded
- Who does not know which intervention a participant is receiving. It can apply to participants, the people giving the treatment, those assessing results, or those analysing the data.
- cohort
- A group of people who share a characteristic, such as a diagnosis, and are studied together. 'Prospective' means they are followed forward from enrolment; 'retrospective' means existing records are reviewed.
- timeframe
- The period over which an outcome is measured, for example 'at 12 weeks'. It is not necessarily the total length of the study.
- follow-up
- The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
- observational study
- A study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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