Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2026-02-20 @ 4:31 PM
Study NCT ID:
NCT05273957
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-25
First Post:
2022-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Model of Hospital-Territory Management Coordinated by a Case Manager to Improve the Care of Patients With Parkinsonism.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D010302', 'term': 'Parkinson Disease, Secondary'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000071959', 'term': 'Case Managers'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D006282', 'term': 'Health Personnel'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 121}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-22', 'studyFirstSubmitDate': '2022-03-01', 'studyFirstSubmitQcDate': '2022-03-01', 'lastUpdatePostDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Changes in total score of the Parkinson's Disease Questionnaire 39-items scale", 'timeFrame': 'baseline, week 52', 'description': "Thi is a 39-items questionnaire assessing the quality of life of patient with Parkinson's disease. The higher the score the lower the quality of life"}], 'secondaryOutcomes': [{'measure': 'Number of unscheduled hospital access over the 12-month study period', 'timeFrame': 'baseline, week 26, week 52', 'description': 'The investigators will collect the sum of the number of (i) extra unscheduled outpatient visits, (ii) emergency room visits, (iii) hospital admissions directly or indirectly associated with parkinsonism'}, {'measure': "Changes in the Movement Disorder Society Unified Parkinson's Disease Rating Scale part II", 'timeFrame': 'baseline, week 52', 'description': 'This is a scale (MDS-UPDRS) used to assess activities of daily living. The higher the score the worse the Disability'}, {'measure': "Changes in the Movement Disorder Society Unified Parkinson's Disease Rating Scale part IV", 'timeFrame': 'baseline, week 52', 'description': 'This is a scale (MDS-UPDRS) used to assess complications of dopaminergic therapy. The higher the score the worse the disability'}, {'measure': 'Changes in the Non-Motor Symptoms Scale score', 'timeFrame': 'baseline, week 52', 'description': "This is a scale used to assess the burden of non-motor symptoms in Parkinson's disease. The higher the score the worse the disability"}, {'measure': 'Changes in the activities of daily living questionnaire', 'timeFrame': 'baseline, week 52', 'description': 'The "ADL (Activities of Daily Living)" evaluation refers to the fundamental activities of daily life in which the subject is dependent: on a scale from 0 to 6 points, the lower the score, the greater the person\'s need for assistance'}, {'measure': 'Changes in the instrumental activities of daily living questionnaire', 'timeFrame': 'baseline, week 52', 'description': 'The "IADL (Instrumental Activities of Daily Living)" evaluation refers to the instrumental activities of daily life in which the subject is dependent (eg using telephone, preparing meals, taking medications, etc): on a scale from 0 to 8 points, the lower the score, the greater the person\'s need for assistance'}, {'measure': 'Changes in patient experience questionnaire', 'timeFrame': 'baseline, week 26, week 52', 'description': 'This is a questionnaire assessing patient perception and satisfaction of the quality of health care'}, {'measure': 'Changes in EuroQOL-5 Dimensions-5 Levels score', 'timeFrame': 'baseline, week 52', 'description': "This is a useful and validated instrument to measure quality of life in patients with Parkinson's disease"}, {'measure': 'Changes in the Morisky Medical Adherence scale-8 items score', 'timeFrame': 'baseline, week 26, week 52', 'description': 'This is an 8-items scale used to investigate patient adherence to the therapy prescribed by the MD specialist'}, {'measure': 'Changes in the Zarit Burden Interview scale score', 'timeFrame': 'baseline, week 26, week 52', 'description': "This is a scale used to investigate caregiver's burnout"}, {'measure': 'Number of incident comorbidities', 'timeFrame': 'baseline, week 26, week 52', 'description': 'The number of incident comorbidities over the 12.month study period will be assessed using a semistructured interview'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Parkinson Disease', 'Case Manager', 'Parkinson Disease Nurse Specialist'], 'conditions': ['Parkinson Disease', 'Atypical Parkinsonism', 'Secondary Parkinsonism', 'Nurse-Patient Relations', 'Nurse Physician Relations']}, 'referencesModule': {'references': [{'pmid': '23165981', 'type': 'BACKGROUND', 'citation': "van der Marck MA, Bloem BR, Borm GF, Overeem S, Munneke M, Guttman M. Effectiveness of multidisciplinary care for Parkinson's disease: a randomized, controlled trial. Mov Disord. 2013 May;28(5):605-11. doi: 10.1002/mds.25194. Epub 2012 Nov 19."}, {'pmid': '23054239', 'type': 'BACKGROUND', 'citation': 'Willis AW, Schootman M, Tran R, Kung N, Evanoff BA, Perlmutter JS, Racette BA. Neurologist-associated reduction in PD-related hospitalizations and health care expenditures. Neurology. 2012 Oct 23;79(17):1774-80. doi: 10.1212/WNL.0b013e3182703f92. Epub 2012 Oct 10.'}, {'pmid': '26803377', 'type': 'BACKGROUND', 'citation': "Muzerengi S, Herd C, Rick C, Clarke CE. A systematic review of interventions to reduce hospitalisation in Parkinson's disease. Parkinsonism Relat Disord. 2016 Mar;24:3-7. doi: 10.1016/j.parkreldis.2016.01.011. Epub 2016 Jan 13."}, {'pmid': '22400982', 'type': 'BACKGROUND', 'citation': "Gerlach OH, Broen MP, van Domburg PH, Vermeij AJ, Weber WE. Deterioration of Parkinson's disease during hospitalization: survey of 684 patients. BMC Neurol. 2012 Mar 8;12:13. doi: 10.1186/1471-2377-12-13."}, {'pmid': '23835430', 'type': 'BACKGROUND', 'citation': "Hassan A, Wu SS, Schmidt P, Dai Y, Simuni T, Giladi N, Bloem BR, Malaty IA, Okun MS; NPF-QII Investigators. High rates and the risk factors for emergency room visits and hospitalization in Parkinson's disease. Parkinsonism Relat Disord. 2013 Nov;19(11):949-54. doi: 10.1016/j.parkreldis.2013.06.006. Epub 2013 Jul 5."}, {'pmid': '25737205', 'type': 'BACKGROUND', 'citation': "Low V, Ben-Shlomo Y, Coward E, Fletcher S, Walker R, Clarke CE. Measuring the burden and mortality of hospitalisation in Parkinson's disease: A cross-sectional analysis of the English Hospital Episodes Statistics database 2009-2013. Parkinsonism Relat Disord. 2015 May;21(5):449-54. doi: 10.1016/j.parkreldis.2015.01.017. Epub 2015 Feb 17."}, {'pmid': '9617716', 'type': 'BACKGROUND', 'citation': "Peto V, Jenkinson C, Fitzpatrick R. PDQ-39: a review of the development, validation and application of a Parkinson's disease quality of life questionnaire and its associated measures. J Neurol. 1998 May;245 Suppl 1:S10-4. doi: 10.1007/pl00007730."}, {'pmid': '10864606', 'type': 'BACKGROUND', 'citation': "Schrag A, Selai C, Jahanshahi M, Quinn NP. The EQ-5D--a generic quality of life measure-is a useful instrument to measure quality of life in patients with Parkinson's disease. J Neurol Neurosurg Psychiatry. 2000 Jul;69(1):67-73. doi: 10.1136/jnnp.69.1.67."}, {'pmid': '25908544', 'type': 'BACKGROUND', 'citation': "Hellqvist C, Bertero C. Support supplied by Parkinson's disease specialist nurses to Parkinson's disease patients and their spouses. Appl Nurs Res. 2015 May;28(2):86-91. doi: 10.1016/j.apnr.2014.12.008. Epub 2015 Feb 26."}, {'pmid': '22704902', 'type': 'BACKGROUND', 'citation': 'van der Eijk M, Faber MJ, Ummels I, Aarts JW, Munneke M, Bloem BR. Patient-centeredness in PD care: development and validation of a patient experience questionnaire. Parkinsonism Relat Disord. 2012 Nov;18(9):1011-6. doi: 10.1016/j.parkreldis.2012.05.017. Epub 2012 Jun 15.'}, {'pmid': '25791380', 'type': 'BACKGROUND', 'citation': "Qiang JK, Marras C. Telemedicine in Parkinson's disease: A patient perspective at a tertiary care centre. Parkinsonism Relat Disord. 2015 May;21(5):525-8. doi: 10.1016/j.parkreldis.2015.02.018. Epub 2015 Feb 28."}, {'pmid': '27810571', 'type': 'BACKGROUND', 'citation': "Hagell P, Alvariza A, Westergren A, Arestedt K. Assessment of Burden Among Family Caregivers of People With Parkinson's Disease Using the Zarit Burden Interview. J Pain Symptom Manage. 2017 Feb;53(2):272-278. doi: 10.1016/j.jpainsymman.2016.09.007. Epub 2016 Nov 1."}, {'pmid': '28029554', 'type': 'BACKGROUND', 'citation': "Cova I, Di Battista ME, Vanacore N, Papi CP, Alampi G, Rubino A, Valente M, Meco G, Contri P, Di Pucchio A, Lacorte E, Priori A, Mariani C, Pomati S. Validation of the Italian version of the Non Motor Symptoms Scale for Parkinson's disease. Parkinsonism Relat Disord. 2017 Jan;34:38-42. doi: 10.1016/j.parkreldis.2016.10.020. Epub 2016 Oct 24."}, {'pmid': '23728715', 'type': 'BACKGROUND', 'citation': 'Fabbrini G, Abbruzzese G, Barone P, Antonini A, Tinazzi M, Castegnaro G, Rizzoli S, Morisky DE, Lessi P, Ceravolo R; REASON study group. Adherence to anti-Parkinson drug therapy in the "REASON" sample of Italian patients with Parkinson\'s disease: the linguistic validation of the Italian version of the "Morisky Medical Adherence Scale-8 items". Neurol Sci. 2013 Nov;34(11):2015-22. doi: 10.1007/s10072-013-1438-1. Epub 2013 Jun 1.'}, {'pmid': '32464101', 'type': 'BACKGROUND', 'citation': "Bloem BR, Henderson EJ, Dorsey ER, Okun MS, Okubadejo N, Chan P, Andrejack J, Darweesh SKL, Munneke M. Integrated and patient-centred management of Parkinson's disease: a network model for reshaping chronic neurological care. Lancet Neurol. 2020 Jul;19(7):623-634. doi: 10.1016/S1474-4422(20)30064-8. Epub 2020 May 25."}, {'pmid': '32723588', 'type': 'BACKGROUND', 'citation': 'Cilia R, Mancini F, Bloem BR, Eleopra R. Telemedicine for parkinsonism: A two-step model based on the COVID-19 experience in Milan, Italy. Parkinsonism Relat Disord. 2020 Jun;75:130-132. doi: 10.1016/j.parkreldis.2020.05.038. Epub 2020 Jun 10.'}]}, 'descriptionModule': {'briefSummary': "The present multicenter randomized study investigates whether the management of patients with parkinsonism by a nurse specialist (case-manager) can significantly improve patients' quality of life over 12 months, compared to control patients managed with the standard-of-care process.\n\nParticipants will be evaluated with clinical scales testing quality of life, motor and non-motor symptoms, and the number of unscheduled hospital access throughout the course of the study.", 'detailedDescription': 'Several studies provide evidence that a multidisciplinary management of individuals with Parkinson\'s disease (PD) including a specialized nurse may offer significant benefits to patients, in the management of disability due to motor and non-motor symptoms as well as in monitoring compliance to therapy and incident adverse events.\n\nA number of retrospective studies demonstrated that frequent neurologic consultations and a strict adherence to pharmacological therapy can reduce the risk of hospitalization up to 50%. Falls, fractures, infections and cognitive and motor deterioration represent risk factors for hospitalization in patients with PD. These complications are even more frequent in patients affected by atypical parkinsonisms (e.g. multiple system atrophy and progressive supranuclear palsy).\n\nThe optimization of management of motor and non-motor symptoms and pharmacological side effects, through telemedicine services carried out by nurses specialized in movement disorders, can prevent falls and hospitalization, increase quality of life and reduce comorbidities and caregiver\'s burnout.\n\nIn the present study, a "case-manager" will follow-up patients and caregivers, cooperating at the same time with other members of a multidisciplinary team (neurologists, psychologists, physiatrists, general practitioners, social assistants), either within or outside the institute where the neurologist visits, aiming to achieve a better global management of frail patients.\n\nThe present multicenter, randomized, double-blind study will recruit 164 patients affected by Parkinson\'s disease, atypical parkinsonism or secondary parkinsonism with motor and/or non motor complications, living in the Lombardy region (Northern Italy).\n\nPatients will be enrolled in a tertiary referral clinic with expert knowledge (\'hub\': Fondazione IRCCS Istituto Neurologico Carlo besta) and in a community hospital (\'spoke\': Azienda Socio Sanitaria Territoriale Nord Milano).\n\nThe participants will be randomized into two treatment arms: (i) the interventional arm (patients followed by a case manager); (ii) the control arm (the standard-of-care).\n\nAt the baseline and at the visits at 6 and 12 months, clinical scales and questionnaires will be administered to determine if there are differences between the quality of life and the disability of patients between the two arms of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18 years\n* Living in the Lombardy region (Northern Italy)\n* Duration of Parkinson's disease, atypical or secondary parkinsonism ≥ 3 years\n* Presence of at least (i) n=1 motor complication and/or (ii), n=2 non-motor symptoms, defined as follows:\n\n (i) Motor complication:\n* Motor fluctuations\n* ≥ 2 Falls in the last 6 months\n* Dysphagia\n\n(ii) Non Motor symptoms\n\n* Non-motor fluctuations\n* ≥ 2 items of the non-motor symptoms scale with a score ≥ 2\n\nExclusion Criteria:\n\n* Hoehn and Yahr Stage = 5 in the ON-medication condition\n* Psychiatric comorbidity or other neurological chronic diseases that, in the opinion of the recruiting neurologist, could compromise the study participation.\n* Patients on infusional therapies (continuous infusion of levodopa-carbidopa intestinal gel or Continuous Subcutaneous Apomorphine Infusion).\n* Severe medical disease (liver or kidney failure, decompensated heart disease, neoplasms, coagulopathy)"}, 'identificationModule': {'nctId': 'NCT05273957', 'acronym': 'PROUD', 'briefTitle': 'A Model of Hospital-Territory Management Coordinated by a Case Manager to Improve the Care of Patients With Parkinsonism.', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta'}, 'officialTitle': 'A Model of Hospital-territory Management Coordinated by a Case Manager to Improve the Care of Patients With Parkinsonism. A Multicenter, Randomized, Double-blind Study. The PROUD Study', 'orgStudyIdInfo': {'id': 'PROUD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Case Manager', 'description': 'Patients are followed up by a case manager', 'interventionNames': ['Other: Case Manager']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard-of-care', 'description': 'Patients are followed up only by the neurologist', 'interventionNames': ['Other: Standard-of-care']}], 'interventions': [{'name': 'Case Manager', 'type': 'OTHER', 'description': 'Patients are followed up by a nurse specialist in parkinsonism (case manager) who interacts with the treating neurologist and a multidisciplinary team', 'armGroupLabels': ['Case Manager']}, {'name': 'Standard-of-care', 'type': 'OTHER', 'description': "Patients are managed only by the neurologist according the institution's clinical practice", 'armGroupLabels': ['Standard-of-care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20099', 'city': 'Sesto San Giovanni', 'state': 'Milan', 'country': 'Italy', 'facility': 'Azienda Socio-Sanitaria Territoriale Nord Milano', 'geoPoint': {'lat': 45.53329, 'lon': 9.22585}}, {'zip': '20133', 'city': 'Milan', 'country': 'Italy', 'facility': 'Fondazione IRCCS Istituto Neurologico Carlo Besta', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': 'Roberto Eleopra, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione IRCCS Istituto Neurologico Carlo Besta'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months.\n\nExtensions will be considered on a case-by-case basis.', 'ipdSharing': 'YES', 'description': 'Data obtained through this study may be provided to qualified researchers with academic interest on this topic. Data shared will be coded, with no protected health information included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party', 'accessCriteria': 'Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan and execution of a Data Sharing Agreement. For more information or to submit a request, please contact crc@istituto-besta.it'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta', 'class': 'OTHER'}, 'collaborators': [{'name': 'Azienda Socio Sanitaria Territoriale Nord Milano', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}