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Completed
NCT05273957
A Model of Hospital-Territory Management Coordinated by a Case Manager to Improve the Care of Patients With Parkinsonism.
Conditions: Parkinson Disease, Atypical Parkinsonism, Secondary Parkinsonism, Nurse-Patient Relations, Nurse Physician Relations
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 121
Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Location: Azienda Socio-Sanitaria Territoriale Nord Milano Sesto San Giovanni Milan
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.
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)
Source: ClinicalTrials.gov (NCT05273957). StuddyBuddy aggregates publicly available trial information.