A Model of Hospital-Territory Management Coordinated by a Case Manager to Improve the Care of Patients With Parkinsonism.

NCT05273957 | Active Not Recruiting DMC

• 1 other identifier: PROUD
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 2

Brief Summary

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. Participants 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.

Conditions

Parkinson Disease; Atypical Parkinsonism; Secondary Parkinsonism; Nurse-Patient Relations; Nurse Physician Relations

Keywords

Parkinson Disease; Case Manager; Parkinson Disease Nurse Specialist

Outcome Measures

Primary Outcomes (1)

• Changes in total score of the Parkinson's Disease Questionnaire 39-items scale

  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

  baseline, week 52

Secondary Outcomes (11)

• Number of unscheduled hospital access over the 12-month study period

  baseline, week 26, week 52

• Changes in the Movement Disorder Society Unified Parkinson's Disease Rating Scale part II

  baseline, week 52

• Changes in the Movement Disorder Society Unified Parkinson's Disease Rating Scale part IV

  baseline, week 52

• Changes in the Non-Motor Symptoms Scale score

  baseline, week 52

• Changes in the activities of daily living questionnaire

  baseline, week 52

Study Arms (2)

Case Manager

EXPERIMENTAL

Patients are followed up by a case manager

Other: Case Manager

Standard-of-care

ACTIVE COMPARATOR

Patients are followed up only by the neurologist

Other: Standard-of-care

Interventions

Case Manager OTHER

Patients are followed up by a nurse specialist in parkinsonism (case manager) who interacts with the treating neurologist and a multidisciplinary team

Case Manager

Standard-of-care OTHER

Patients are managed only by the neurologist according the institution's clinical practice

Standard-of-care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Living in the Lombardy region (Northern Italy)
• Duration of Parkinson's disease, atypical or secondary parkinsonism ≥ 3 years
• Presence of at least (i) n=1 motor complication and/or (ii), n=2 non-motor symptoms, defined as follows:
• (i) Motor complication:
• Motor fluctuations
• ≥ 2 Falls in the last 6 months
• Dysphagia
• (ii) Non Motor symptoms
• Non-motor fluctuations
• ≥ 2 items of the non-motor symptoms scale with a score ≥ 2

You may not qualify if:

• Hoehn and Yahr Stage = 5 in the ON-medication condition
• Psychiatric comorbidity or other neurological chronic diseases that, in the opinion of the recruiting neurologist, could compromise the study participation.
• Patients on infusional therapies (continuous infusion of levodopa-carbidopa intestinal gel or Continuous Subcutaneous Apomorphine Infusion).
• Severe medical disease (liver or kidney failure, decompensated heart disease, neoplasms, coagulopathy)

Sponsors & Collaborators

• Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta: lead
• Azienda Socio Sanitaria Territoriale Nord Milano: collaborator

Study Sites (2)

Azienda Socio-Sanitaria Territoriale Nord Milano

Sesto San Giovanni, Milan, 20099, Italy

Location

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, 20133, Italy

Location

Related Publications (16)

• 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: 23165981 BACKGROUND

• 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: 23054239 BACKGROUND

• 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: 26803377 BACKGROUND

• 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: 22400982 BACKGROUND

• 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: 23835430 BACKGROUND

• 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: 25737205 BACKGROUND

• 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: 9617716 BACKGROUND

• 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: 10864606 BACKGROUND

• 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: 25908544 BACKGROUND

• 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: 22704902 BACKGROUND

• 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: 25791380 BACKGROUND

• 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: 27810571 BACKGROUND

• 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: 28029554 BACKGROUND

• 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: 23728715 BACKGROUND

• 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: 32464101 BACKGROUND

• 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.

  PMID: 32723588 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Parkinson Disease, Secondary

Interventions

Case Managers; Standard of Care

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Roberto Eleopra, MD

  Fondazione IRCCS Istituto Neurologico Carlo Besta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2022
• First Posted: March 10, 2022
• Study Start: March 29, 2021
• Primary Completion: January 30, 2025
• Study Completion: June 30, 2025
• Last Updated: March 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
• Access Criteria: 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

Locations

IT (2)