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

Sponsor
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta (Other)
Overall Status
Recruiting
CT.gov ID
NCT05273957
Collaborator
Azienda Socio Sanitaria Territoriale Nord Milano (Other)
164
Enrollment
2
Locations
2
Arms
33.1
Anticipated Duration (Months)
82
Patients Per Site
2.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Case Manager
  • Other: Standard-of-care
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
164 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
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
Actual Study Start Date :
Mar 29, 2021
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Changes in total score of the Parkinson's Disease Questionnaire 39-items scale [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

Secondary Outcome Measures

  1. Number of unscheduled hospital access over the 12-month study period [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

  2. Changes in the Movement Disorder Society Unified Parkinson's Disease Rating Scale part II [baseline, week 52]

    This is a scale (MDS-UPDRS) used to assess activities of daily living. The higher the score the worse the Disability

  3. Changes in the Movement Disorder Society Unified Parkinson's Disease Rating Scale part IV [baseline, week 52]

    This is a scale (MDS-UPDRS) used to assess complications of dopaminergic therapy. The higher the score the worse the disability

  4. Changes in the Non-Motor Symptoms Scale score [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

  5. Changes in the activities of daily living questionnaire [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

  6. Changes in the instrumental activities of daily living questionnaire [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

  7. Changes in patient experience questionnaire [baseline, week 26, week 52]

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

  8. Changes in EuroQOL-5 Dimensions-5 Levels score [baseline, week 52]

    This is a useful and validated instrument to measure quality of life in patients with Parkinson's disease

  9. Changes in the Morisky Medical Adherence scale-8 items score [baseline, week 26, week 52]

    This is an 8-items scale used to investigate patient adherence to the therapy prescribed by the MD specialist

  10. Changes in the Zarit Burden Interview scale score [baseline, week 26, week 52]

    This is a scale used to investigate caregiver's burnout

  11. Number of incident comorbidities [baseline, week 26, week 52]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Azienda Socio-Sanitaria Territoriale Nord Milano Sesto San Giovanni Milan Italy 20099
2 Fondazione IRCCS Istituto Neurologico Carlo Besta Milan Italy 20133

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
ClinicalTrials.gov Identifier:
NCT05273957
Other Study ID Numbers:
  • PROUD
First Posted:
Mar 10, 2022
Last Update Posted:
Mar 10, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Parkinson Disease
Case Manager
Parkinson Disease Nurse Specialist
Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Parkinson Disease, Secondary

Study Results

No Results Posted as of Mar 10, 2022