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Parkinson DiseasePROUDNCT05273957

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

A study testing Case Manager and Standard-of-care in people with Parkinson Disease and Atypical Parkinsonism, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 2 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Case Manager and Standard-of-care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
121 participants
Where
2 sitesItaly
Study dates
29 Mar 2021to 30 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • Motor complication:
  • Motor fluctuations
Show all 11Show fewer
  • ≥ 2 Falls in the last 6 months
  • Dysphagia
  • Non Motor symptoms
  • Non-motor fluctuations
  • ≥ 2 items of the non-motor symptoms scale with a score ≥ 2

Who cannot join

  • 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)

Trial locations and contacts

2 sites in 1 country.

Italy2 sites

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    Milan, 20133

  • Azienda Socio-Sanitaria Territoriale Nord Milano

    Sesto San Giovanni, Milan, 20099

Other trials in Italy

About this study

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

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.

Read the detailed 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.

Being tested
Case Manager, Standard-of-care
Keywords
Parkinson Disease, Case Manager, Parkinson Disease Nurse Specialist
Medical subject headings
Parkinson Disease, Parkinson Disease, Secondary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Case ManagerOther

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

  • Standard-of-careOther

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

Study groups in NCT05273957
Study groupRoleWhat they receive
Case ManagerExperimentalPatients are followed up by a case manager
Receives: Other: Case Manager
Standard-of-careActive comparatorPatients are followed up only by the neurologist
Receives: Other: Standard-of-care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: baseline, week 52

Secondary outcomes (11)

  1. 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

    Measured: baseline, week 26, week 52

  2. 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

    Measured: baseline, week 52

  3. 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

    Measured: baseline, week 52

  4. 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

    Measured: baseline, week 52

  5. 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

    Measured: baseline, week 52

  6. 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

    Measured: baseline, week 52

  7. Changes in patient experience questionnaire

    This is a questionnaire assessing patient perception and satisfaction of the quality of health care

    Measured: baseline, week 26, week 52

  8. 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

    Measured: baseline, week 52

  9. 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

    Measured: baseline, week 26, week 52

  10. Changes in the Zarit Burden Interview scale score

    This is a scale used to investigate caregiver's burnout

    Measured: baseline, week 26, week 52

  11. Number of incident comorbidities

    The number of incident comorbidities over the 12.month study period will be assessed using a semistructured interview

    Measured: baseline, week 26, week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2022
  2. Study start29 Mar 2021
  3. Primary completion30 Jan 2025
  4. Study completion30 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05273957
Sponsor's protocol ID
PROUD
Acronym
PROUD
Status last verified
Aug 2026
First submitted
1 Mar 2022
Last updated
31 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • 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.

    PubMed 23165981

  • 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.

    PubMed 23054239

  • 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.

    PubMed 26803377

  • 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.

    PubMed 22400982

  • 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.

    PubMed 23835430

  • 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.

    PubMed 25737205

  • 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.

    PubMed 9617716

  • 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.

    PubMed 10864606

  • 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.

    PubMed 25908544

  • 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.

    PubMed 22704902

  • 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.

    PubMed 25791380

  • 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.

    PubMed 27810571

  • 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.

    PubMed 28029554

  • 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.

    PubMed 23728715

  • 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.

    PubMed 32464101

Questions about this trial

What is this clinical trial studying?

A study testing Case Manager and Standard-of-care in people with Parkinson Disease and Atypical Parkinsonism, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 2 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in total score of the Parkinson's Disease Questionnaire 39-items scale (time frame: baseline, week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05273957, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.

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