Home-based care for patients with atypical parkinsonism
Integrated Management of Atypical Parkinsonism: A Home-based Patient-Centered Healthcare Delivery Based on Telenursing. A Multicenter, Interventional Non-pharmacological, Randomized, Single-blind Clinical Trial. IMPACT Study
This study is testing a new home-based care program for people with atypical parkinsonism, like Multiple System Atrophy and Progressive Supranuclear Palsy, to see if it can improve their quality of life compared to regular medical care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 164 (estimated) |
| Ages | 40 Years to 85 Years |
| Sex | All |
| Sponsor | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta Academic / other |
| Locations | 4 sites (Messina and 3 other locations) |
| Trial ID | NCT05792332 on ClinicalTrials.gov |
What this trial studies
This project investigates an integrated model of care for patients with atypical parkinsonism, specifically focusing on Multiple System Atrophy (MSA) and Progressive Supranuclear Palsy (PSP). The approach involves proactive and reactive telenursing monitoring coordinated by a specialized nurse to enhance care delivery and improve patients' quality of life. The study will recruit 164 patients to compare the efficacy and cost-effectiveness of this home-based program against standard medical care over a 12-month period. The goal is to simplify and standardize patient care while optimizing monitoring and management of complications.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with MSA or PSP in any of their clinical variants.
Not a fit: Patients with advanced disease stages or serious medical disorders that impair participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the quality of life and care for patients with atypical parkinsonism.
How similar studies have performed: While integrated care models have been proposed previously, this specific approach utilizing telenursing is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Clinical diagnosis of MSA or PSP in all their possible variants (MSA-P, MSA-C; PSP-RS, PSP-P, PSP-CBS, etc.) according to internationally validated criteria. Exclusion Criteria: * Hoehn and Yahr stage = 5 in ON phase * Clinical Frialty Scale (CFS) ≥ 8 * Serious medical disorders that, in the opinion of the recruiting neurologist, may impair participation in the study
Where this trial is running
Messina and 3 other locations
- Azienda Ospedaliera Universitaria Gaetano Martino — Messina, Italy (Recruiting)
- Fondazione IRCCS Istituto Neurologico Carlo Besta — Milan, Italy (Recruiting)
- Fondazione IRCCS Istituto Neurologico Nazionale Casmiro Mondino — Pavia, Italy (Recruiting)
- IRCCS Neuromed — Pozzilli, Italy (Recruiting)
Study contacts
- Principal investigator: Roberto Eleopra, MD — Study Principal Investigator Fondazione IRCCS Istituto Neurologico Carlo Besta
- Study coordinator: Roberto Cilia, MD
- Email: neuro1@istituto-besta.it
- Phone: (+39)0223941
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.