Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
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)

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05273957). StuddyBuddy aggregates publicly available trial information.