Status:
ACTIVE_NOT_RECRUITING
A Model of Hospital-Territory Management Coordinated by a Case Manager to Improve the Care of Patients With Parkinsonism.
Lead Sponsor:
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Collaborating Sponsors:
Azienda Socio Sanitaria Territoriale Nord Milano
Conditions:
Parkinson Disease
Atypical Parkinsonism
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 manag...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT05273957
Start Date
March 29 2021
End Date
June 30 2025
Last Update
March 25 2024
Active Locations (2)
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1
Azienda Socio-Sanitaria Territoriale Nord Milano
Sesto San Giovanni, Milan, Italy, 20099
2
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Italy, 20133