Clinical trial NCT05273957: A Model of Hospital-Territory Management Coordinated by a Case Manager to Improve the Care of Patients With Parkinsonism.
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Atypical Parkinsonism
Secondary Parkinsonism
Nurse-Patient Relations
Nurse Physician Relations
Keywords: Parkinson Disease
Case Manager
Parkinson Disease Nurse Specialist
Lead sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Sponsor class: OTHER
Collaborators: name: Azienda Socio Sanitaria Territoriale Nord Milano
First posted: 2022-03-10
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Changes in total score of the Parkinson's Disease Questionnaire 39-items scale
timeFrame: baseline, week 52
Secondary outcomes:
measure: Number of unscheduled hospital access over the 12-month study period
timeFrame: baseline, week 26, week 52
measure: Changes in the Movement Disorder Society Unified Parkinson's Disease Rating Scale part II
timeFrame: baseline, week 52
measure: Changes in the Movement Disorder Society Unified Parkinson's Disease Rating Scale part IV
timeFrame: baseline, week 52
measure: Changes in the Non-Motor Symptoms Scale score
timeFrame: baseline, week 52
measure: Changes in the activities of daily living questionnaire
timeFrame: baseline, week 52
measure: Changes in the instrumental activities of daily living questionnaire
timeFrame: baseline, week 52
measure: Changes in patient experience questionnaire
timeFrame: baseline, week 26, week 52
measure: Changes in EuroQOL-5 Dimensions-5 Levels score
timeFrame: baseline, week 52
measure: Changes in the Morisky Medical Adherence scale-8 items score
timeFrame: baseline, week 26, week 52
measure: Changes in the Zarit Burden Interview scale score
timeFrame: baseline, week 26, week 52
measure: Number of incident comorbidities
timeFrame: baseline, week 26, week 52
Other outcomes:
Locations:
city: Sesto San Giovanni
country: Italy
facility: Azienda Socio-Sanitaria Territoriale Nord Milano
state: Milan
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Neurologico Carlo Besta
Study officials:
affiliation: Fondazione IRCCS Istituto Neurologico Carlo Besta
name: Roberto Eleopra, MD
role: PRINCIPAL_INVESTIGATOR
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