Objective: To present the protocol of a study evaluating the efficacy and cost-effectiveness of a 12-month integrated program aimed at improving healthcare delivery and coordinated by a nurse specialised in the management of people with parkinsonism (PKNS).

Background: People with atypical parkinsonism suffer from troublesome symptoms leading to a highly complex care delivery and increased risk of complications and hospitalisations, ultimately resulting in poor quality of life and high societal costs.

Method: This is a multicentre, randomised, controlled, single-blind clinical trial. Inclusion criteria are clinical diagnosis of Multiple system atrophy or Progressive supranuclear palsy according to internationally validated criteria; exclusion criteria are Hoehn and Yahr stage˃4, Clinical Frailty Scale score≥8, and serious medical disorders interfering with study participation. Participants are randomised with a 1:1 ratio to either the intervention (PKNS) or the control (standard-of-care) arms. Assessments are undertaken at baseline and after 6 and 12 months. The primary outcome measure is changes in the Parkinson’s Disease Questionnaire 39-item score between baseline and 12 months. Secondary measures include clinical scales for motor and non-motor symptoms, caregiver burden, adherence to therapy, cumulative disease burden, and the number of unplanned hospital visits/admissions during the study period. The cost-effectiveness is evaluated by using the EuroQoL-5, which estimates the incremental cost per quality-adjusted life-years gain. Real-life motor autonomy is objectively measured by collecting waist-worn wearable data on gait parameters (automatically detecting motor patterns indicative of freezing of gait and falls) in all subjects for 5 consecutive days each month during the 12-month duration of the study.

Results: Study recruitment is completed with 165 participants recruited as of 31/12/2025. Study visits and data collection are ongoing.

Conclusion: An integrated remote care model coordinated by a PKNS may be beneficial for patients, caregivers, healthcare professionals, and society. Acknowledgements. The ongoing project PNRR-MR1-2022-12376921 is Funded by the European Union-Next Generation EU-NRRP M6C2-Investment 2.1 Enhancement and strengthening of biomedical research in the NHS.

References: [1] van der Marck MA, et al. Effectiveness of multidisciplinary care for Parkinson’s disease: a randomized, controlled trial. Mov Disord 2013;28:605–11.
[2] Cilia R, Mancini F, Bloem BR, Eleopra R. Telemedicine for parkinsonism: A two-step model based on the COVID-19 experience in Milan, Italy. Parkinsonism Relat Disord. 2020;75:130-132.

« Back to 2025 International Congress

MDS Abstracts - https://www.mdsabstracts.org/abstract/the-impact-study-protocol-of-a-randomised-controlled-single-blind-trial-evaluating-efficacy-and-cost-effectiveness-of-telenursing-in-atypical-parkinsonism/