Medical Decision Making in Multiple System Atrophy
- Conditions
- Multiple System Atrophy
- Interventions
- Other: Telemedicine visitsOther: Multidisciplinary, personalized symptomatic treatment
- Registration Number
- NCT06072105
- Lead Sponsor
- Medical University Innsbruck
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 92
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 2 Multidisciplinary, personalized symptomatic treatment Personalized best medical care PLUS telemedicine Group 2 Telemedicine visits Personalized best medical care PLUS telemedicine Group 1 Multidisciplinary, personalized symptomatic treatment Personalized best medical care.
- Primary Outcome Measures
Name Time Method Change in the EQ-5D-5L score 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.
- Secondary Outcome Measures
Name Time Method Changes in the MSA-QoL score and subscores 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.
Change in motor and non-motor scales 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.
Time to clinical milestones 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.
Changes in the individual healthcare preferences assessed by means of the Autonomy Preference Index (API) Baseline to 12- months Assessment of individual preferences about the individual healthcare
In-person and telemedicine medical, psychological and neurorehabilitation interventional needs of individuals with MSA over the 18-months study period Registration of the need of support required by MSA patients
Change in the Short Assessment of Patient Satisfaction (SAPS) referred to the overall individualized treatment plan Month 1 to 7, 13 and 18 Assessment of patients´ level of satisfaction with the individuaized treatment plan
Individual satisfaction with the single telemedicine and mobile palliative interventions over the 18-months study period The individual satisfaction will be assessed by means of online numeric rating scales and open-ended questions
Healthcare professionals satisfaction with the single telemedicine and mobile palliative interventions 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
Number of medical complications 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)
Single-intervention and cumulative healthcare costs over the 18-months study period Record of healthcare costs
Changes in the EQ-5D-5L score of informal caregivers of individuals with MSA recruited in the present study 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.
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 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.
Trial Locations
- Locations (1)
Innsbruck Medical University
🇦🇹Innsbruck, Austria