Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:13 AM
Study NCT ID:
NCT06072105
Status:
RECRUITING
Last Update Posted:
2025-02-05
First Post:
2023-10-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Medical Decision Making in Multiple System Atrophy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019578', 'term': 'Multiple System Atrophy'}, {'id': 'D009069', 'term': 'Movement Disorders'}], 'ancestors': [{'id': 'D054969', 'term': 'Primary Dysautonomias'}, {'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 92}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-03', 'studyFirstSubmitDate': '2023-10-02', 'studyFirstSubmitQcDate': '2023-10-02', 'lastUpdatePostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the EQ-5D-5L score', 'timeFrame': 'Baseline to 18-months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Changes in the MSA-QoL score and subscores', 'timeFrame': 'Baseline to 6-, 12- and 18-months', 'description': '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.'}, {'measure': 'Change in motor and non-motor scales', 'timeFrame': 'Baseline to 6-, 12- and 18-months', 'description': '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.'}, {'measure': 'Time to clinical milestones', 'timeFrame': 'over the 18-months study period', 'description': 'The clinical milestones are falls at least once a day, feeding by nasogastric tube or gastrostomy, unintelligible speech, indwelling catheter, wheelchair dependency.'}, {'measure': 'Changes in the individual healthcare preferences assessed by means of the Autonomy Preference Index (API)', 'timeFrame': 'Baseline to 12- months', 'description': 'Assessment of individual preferences about the individual healthcare'}, {'measure': 'In-person and telemedicine medical, psychological and neurorehabilitation interventional needs of individuals with MSA', 'timeFrame': 'over the 18-months study period', 'description': 'Registration of the need of support required by MSA patients'}, {'measure': 'Change in the Short Assessment of Patient Satisfaction (SAPS) referred to the overall individualized treatment plan', 'timeFrame': 'Month 1 to 7, 13 and 18', 'description': 'Assessment of patients´ level of satisfaction with the individuaized treatment plan'}, {'measure': 'Individual satisfaction with the single telemedicine and mobile palliative interventions', 'timeFrame': 'over the 18-months study period', 'description': 'The individual satisfaction will be assessed by means of online numeric rating scales and open-ended questions'}, {'measure': 'Healthcare professionals satisfaction with the single telemedicine and mobile palliative interventions', 'timeFrame': 'over the 18-months study period', 'description': 'The individual healthcare professionals satisfaction will be assessed by means of online numeric rating scales and open-ended questions'}, {'measure': 'Number of medical complications', 'timeFrame': 'over the 18-months study period', 'description': 'Record of number of medical complications occurred (e.g. falls with or w/o injuries, urinary tract infections, choking, aspiration pneumonia, hospitalizations, death, others)'}, {'measure': 'Single-intervention and cumulative healthcare costs', 'timeFrame': 'over the 18-months study period', 'description': 'Record of healthcare costs'}, {'measure': 'Changes in the EQ-5D-5L score of informal caregivers of individuals with MSA recruited in the present study', 'timeFrame': 'Baseline to 6-, 12- and 18-months', 'description': '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.'}, {'measure': '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', 'timeFrame': 'Baseline to 6-, 12- and 18-months', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MSA', 'Movement disorders', 'Autonomic dysfunctions', 'Telemedicine', 'Palliative care', 'Caregivers burden'], 'conditions': ['Multiple System Atrophy']}, 'referencesModule': {'references': [{'pmid': '35445419', 'type': 'BACKGROUND', 'citation': 'Wenning GK, Stankovic I, Vignatelli L, Fanciulli A, Calandra-Buonaura G, Seppi K, Palma JA, Meissner WG, Krismer F, Berg D, Cortelli P, Freeman R, Halliday G, Hoglinger G, Lang A, Ling H, Litvan I, Low P, Miki Y, Panicker J, Pellecchia MT, Quinn N, Sakakibara R, Stamelou M, Tolosa E, Tsuji S, Warner T, Poewe W, Kaufmann H. The Movement Disorder Society Criteria for the Diagnosis of Multiple System Atrophy. Mov Disord. 2022 Jun;37(6):1131-1148. doi: 10.1002/mds.29005. Epub 2022 Apr 21.'}, {'pmid': '24095129', 'type': 'BACKGROUND', 'citation': 'Wenning GK, Krismer F. Multiple system atrophy. Handb Clin Neurol. 2013;117:229-41. doi: 10.1016/B978-0-444-53491-0.00019-5.'}, {'pmid': '23910610', 'type': 'BACKGROUND', 'citation': 'Kwakkenbos L, Fransen J, Vonk MC, Becker ES, Jeurissen M, van den Hoogen FH, van den Ende CH. A comparison of the measurement properties and estimation of minimal important differences of the EQ-5D and SF-6D utility measures in patients with systemic sclerosis. Clin Exp Rheumatol. 2013 Mar-Apr;31(2 Suppl 76):50-6. Epub 2013 Jul 22.'}, {'pmid': '25587949', 'type': 'BACKGROUND', 'citation': 'Fanciulli A, Wenning GK. Multiple-system atrophy. N Engl J Med. 2015 Jan 15;372(3):249-63. doi: 10.1056/NEJMra1311488. 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Epub 2020 Oct 6.'}, {'pmid': '34895020', 'type': 'BACKGROUND', 'citation': "Alonso CCG, de Freitas PB, Pires RS, De Oliveira DL, Freitas SMSF. Exploring the ability of strength and dexterity tests to detect hand function impairment in individuals with Parkinson's disease. Physiother Theory Pract. 2023 Feb;39(2):395-404. doi: 10.1080/09593985.2021.2013371. Epub 2021 Dec 12."}, {'pmid': '32414177', 'type': 'BACKGROUND', 'citation': "Ona ED, Jardon A, Cuesta-Gomez A, Sanchez-Herrera-Baeza P, Cano-de-la-Cuerda R, Balaguer C. Validity of a Fully-Immersive VR-Based Version of the Box and Blocks Test for Upper Limb Function Assessment in Parkinson's Disease. Sensors (Basel). 2020 May 13;20(10):2773. doi: 10.3390/s20102773."}, {'pmid': '30697635', 'type': 'BACKGROUND', 'citation': 'De Dobbeleer L, Beyer I, Hansen AM, Molbo D, Mortensen EL, Lund R, Bautmans I. Grip Work Measurement with the Jamar Dynamometer: Validation of a Simple Equation for Clinical Use. J Nutr Health Aging. 2019;23(2):221-224. doi: 10.1007/s12603-019-1155-4.'}, {'pmid': '34180423', 'type': 'BACKGROUND', 'citation': 'Bartolome G, Starrost U, Schroter-Morasch H, Schilling B, Fischbacher L, Kues L, Graf S, Ziegler W. Validation of the Munich Swallowing Score (MUCSS) in patients with neurogenic dysphagia: A preliminary study. NeuroRehabilitation. 2021;49(3):445-457. doi: 10.3233/NRE-210011.'}, {'pmid': '29058089', 'type': 'BACKGROUND', 'citation': 'Eschlbock S, Wenning G, Fanciulli A. Evidence-based treatment of neurogenic orthostatic hypotension and related symptoms. J Neural Transm (Vienna). 2017 Dec;124(12):1567-1605. doi: 10.1007/s00702-017-1791-y. Epub 2017 Oct 22.'}, {'pmid': '23391524', 'type': 'BACKGROUND', 'citation': 'Wenning GK, Geser F, Krismer F, Seppi K, Duerr S, Boesch S, Kollensperger M, Goebel G, Pfeiffer KP, Barone P, Pellecchia MT, Quinn NP, Koukouni V, Fowler CJ, Schrag A, Mathias CJ, Giladi N, Gurevich T, Dupont E, Ostergaard K, Nilsson CF, Widner H, Oertel W, Eggert KM, Albanese A, del Sorbo F, Tolosa E, Cardozo A, Deuschl G, Hellriegel H, Klockgether T, Dodel R, Sampaio C, Coelho M, Djaldetti R, Melamed E, Gasser T, Kamm C, Meco G, Colosimo C, Rascol O, Meissner WG, Tison F, Poewe W; European Multiple System Atrophy Study Group. The natural history of multiple system atrophy: a prospective European cohort study. Lancet Neurol. 2013 Mar;12(3):264-74. doi: 10.1016/S1474-4422(12)70327-7. Epub 2013 Feb 5.'}, {'pmid': '22990084', 'type': 'BACKGROUND', 'citation': 'Siebert U, Alagoz O, Bayoumi AM, Jahn B, Owens DK, Cohen DJ, Kuntz KM. State-transition modeling: a report of the ISPOR-SMDM Modeling Good Research Practices Task Force-3. Med Decis Making. 2012 Sep-Oct;32(5):690-700. doi: 10.1177/0272989X12455463.'}, {'pmid': '18601792', 'type': 'BACKGROUND', 'citation': 'Drummond MF, Schwartz JS, Jonsson B, Luce BR, Neumann PJ, Siebert U, Sullivan SD. Key principles for the improved conduct of health technology assessments for resource allocation decisions. Int J Technol Assess Health Care. 2008 Summer;24(3):244-58; discussion 362-8. doi: 10.1017/S0266462308080343.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nAfter 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.\n\nForty-six informal caregivers will be invited to participate with semi-structured online interviews and assessment of their QoL and caregivers' burden.", 'detailedDescription': "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.\n\nWe 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.\n\nSix, 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.\n\nAt 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.\n\nAt 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.\n\nAt month 1, 7, 13 and 18, the study participants will be invited to complete online satisfaction surveys with the overall individualized treatment plan.\n\nTwenty-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.\n\nUpon 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.\n\nInformal 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nFor individuals with MSA:\n\n* Age ≥30 years at the time of consent;\n* Diagnosed with clinically probable or clinically established MSA according to the current MDS MSA criteria (1);\n* Life-expectancy of at least 24 months as assessed by the investigator at the time of consent;\n* 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);\n* Signed and dated informed consent document;\n* Fluency in German;\n* 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.\n\nFor informal caregivers:\n\n* Informal caregiver (i.e. person not receiving payment for his/her caregiving) of an individual with MSA recruited in the present study;\n* Life-expectancy of at least 24 months as assessed by the investigator at the time of consent;\n* Age≥ 18 years at the time of consent;\n* Understands and agrees to provide information as outlined in the study protocol and to engage in semi-structured online interviews;\n* Provides signed and dated written informed consent;\n* Full legal capacity;\n* Fluency in German.\n\nExclusion Criteria\n\nFor individuals with MSA\n\n* 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;\n* Charlson comorbidity index \\>4 at the time of consent;\n* Other major underlying medical conditions that may confound interpretation of study results as assessed by the investigator.'}, 'identificationModule': {'nctId': 'NCT06072105', 'acronym': 'MeDeMSA', 'briefTitle': 'Medical Decision Making in Multiple System Atrophy', 'organization': {'class': 'OTHER', 'fullName': 'Medical University Innsbruck'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '1225/2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1', 'description': 'Personalized best medical care.', 'interventionNames': ['Other: Multidisciplinary, personalized symptomatic treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'Personalized best medical care PLUS telemedicine', 'interventionNames': ['Other: Telemedicine visits', 'Other: Multidisciplinary, personalized symptomatic treatment']}], 'interventions': [{'name': 'Telemedicine visits', 'type': 'OTHER', 'description': 'Monthly telemedicine neurological, psychological and neurorehabilitation (physio-, occupational and speech therapy) consultations', 'armGroupLabels': ['Group 2']}, {'name': 'Multidisciplinary, personalized symptomatic treatment', 'type': 'OTHER', 'description': 'Multidisciplinary, personalized symptomatic treatment plus mobile palliative care interventions (if wished and needed)', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6020', 'city': 'Innsbruck', 'state': 'Austria', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Alessandra Fanciulli, MD PhD', 'role': 'CONTACT', 'email': 'alessandra.fanciulli@i-med.ac.at', 'phone': '+4351250483238'}], 'facility': 'Innsbruck Medical University', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}], 'centralContacts': [{'name': 'Alessandra Fanciulli, MD PhD', 'role': 'CONTACT', 'email': 'alessandra.fanciulli@i-med.ac.at', 'phone': '+4351250483238'}], 'overallOfficials': [{'name': 'Alessandra Fanciulli, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medizinische Universität Innsbruck'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University Innsbruck', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof. MD PhD', 'investigatorFullName': 'Alessandra Fanciulli', 'investigatorAffiliation': 'Medical University Innsbruck'}}}}