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

March 22, 2024 updated by: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

121

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20133
        • Fondazione IRCCS Istituto Neurologico Carlo Besta
    • Milan
      • Sesto San Giovanni, Milan, Italy, 20099
        • Azienda Socio-Sanitaria Territoriale Nord Milano

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Case Manager
Patients are followed up by a case manager
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
Active Comparator: Standard-of-care
Patients are followed up only by the neurologist
Other: Standard-of-care
Patients are managed only by the neurologist according the institution's clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in total score of the Parkinson's Disease Questionnaire 39-items scale
Time Frame: baseline, week 52
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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Collaborators

Azienda Socio Sanitaria Territoriale Nord Milano

Investigators

  • Principal Investigator: Roberto Eleopra, MD, Fondazione IRCCS Istituto Neurologico Carlo Besta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2021

Primary Completion (Estimated)

January 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

March 1, 2022

First Submitted That Met QC Criteria

March 1, 2022

First Posted (Actual)

March 10, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2024

Last Update Submitted That Met QC Criteria

March 22, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROUD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan 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

IPD Sharing 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.

IPD Sharing 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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