Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-30 @ 12:12 AM
Study NCT ID:
NCT05273957
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-25
First Post:
2022-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Organization:
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROUD
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: