NCT05273957Completed
A Model of Hospital-Territory Management Coordinated by a Case Manager to Improve the Care of Patients With Parkinsonism.
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
Source: ClinicalTrials.gov · Last updated 31 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 121 (actual)
- First submitted
- 1 Mar 2022
- Start date
- 29 Mar 2021
- Primary completion date
- 30 Jan 2025
- Lead sponsor
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
- Diseases
- Parkinson disease
- NCT number
- NCT05273957
What you commit to
- Study type: Interventional
- Participants enrolled: 121
- From 29 Mar 2021 to the primary completion date, 30 Jan 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients on infusional therapies (continuous infusion of levodopa-carbidopa intestinal gel or Continuous Subcutaneous Apomorphine Infusion).
Other illness
- 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.
- Severe medical disease (liver or kidney failure, decompensated heart disease, neoplasms, coagulopathy)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione IRCCS Istituto Neurologico Carlo Besta Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Azienda Socio-Sanitaria Territoriale Nord Milano Coordinator of this site? Confirm its status | Sesto San Giovanni | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.