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

Parkinson Disease Clinical Trial

— PROUD  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05273957
• Other study ID #: PROUD
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 29, 2021
• Est. completion date: June 30, 2025

Study information

• Verified date: March 2024
• Source: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

A 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).

The 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.

In 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.

The 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).

Patients 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).

The 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).

At 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 121
• Est. completion date: June 30, 2025
• Est. primary completion date: January 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Atypical Parkinsonism
• Nurse Physician Relations
• Nurse-Patient Relations
• Parkinson Disease
• Parkinson Disease, Secondary
• Parkinsonian Disorders
• Secondary Parkinsonism

Intervention

Other:
• Case Manager
Patients are followed up by a nurse specialist in parkinsonism (case manager) who interacts with the treating neurologist and a multidisciplinary team
• Standard-of-care
Patients are managed only by the neurologist according the institution's clinical practice

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Istituto Neurologico Carlo Besta	Milan
Italy	Azienda Socio-Sanitaria Territoriale Nord Milano	Sesto San Giovanni	Milan

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta	Azienda Socio Sanitaria Territoriale Nord Milano

Country where clinical trial is conducted

Italy, 

References & Publications (16)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of unscheduled hospital access over the 12-month study period	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	baseline, week 26, week 52
Secondary	Changes in the Movement Disorder Society Unified Parkinson's Disease Rating Scale part II	This is a scale (MDS-UPDRS) used to assess activities of daily living. The higher the score the worse the Disability	baseline, week 52
Secondary	Changes in the Movement Disorder Society Unified Parkinson's Disease Rating Scale part IV	This is a scale (MDS-UPDRS) used to assess complications of dopaminergic therapy. The higher the score the worse the disability	baseline, week 52
Secondary	Changes in the Non-Motor Symptoms Scale score	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	baseline, week 52
Secondary	Changes in the activities of daily living questionnaire	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	baseline, week 52
Secondary	Changes in the instrumental activities of daily living questionnaire	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	baseline, week 52
Secondary	Changes in patient experience questionnaire	This is a questionnaire assessing patient perception and satisfaction of the quality of health care	baseline, week 26, week 52
Secondary	Changes in EuroQOL-5 Dimensions-5 Levels score	This is a useful and validated instrument to measure quality of life in patients with Parkinson's disease	baseline, week 52
Secondary	Changes in the Morisky Medical Adherence scale-8 items score	This is an 8-items scale used to investigate patient adherence to the therapy prescribed by the MD specialist	baseline, week 26, week 52
Secondary	Changes in the Zarit Burden Interview scale score	This is a scale used to investigate caregiver's burnout	baseline, week 26, week 52
Secondary	Number of incident comorbidities	The number of incident comorbidities over the 12.month study period will be assessed using a semistructured interview	baseline, week 26, week 52