Integrated Management of Atypical Parkinsonism: A Home-based Patient-Centered Healthcare Delivery Based on Telenursing (IMPACT Study)

NCT05792332 | Active Not Recruiting DMC

• 1 other identifier: IMPACT
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 4

Brief Summary

This project aims to investigate whether an integrated model based on proactive and reactive telenursing monitoring coordinated by a parkinsonism nurse specialist (case manager) is able to improve care delivery and quality of life of patients with atypical parkinsonisms. This could reduce the risk (e.g. through health education counselling) and the severity of complications (e.g. falls). Main responsibilities of the Co-PI: project idea and supervision, coordination of the study, patient selection and recruitment, patient recruitment, participation in statistical analysis and drafting the manuscript. Co-PI is responsible of the rate of recruitment and drop-out

Conditions

Atypical Parkinsonism; MSA - Multiple System Atrophy; PSP; Nurse-Patient Relations; Nurse Physician Relations

Keywords

Atypical parkinsonism; Nurse Specialist; MSA; PSP

Outcome Measures

Primary Outcomes (1)

• Changes in total score of the Parkinson's Disease Questionnaire 39-items scale (PDQ-39)

  Thi is a 39-items questionnaire assessing the quality of life of patient with Parkinsonism. Score is expressed in percentage from 0% to 100%. The higher the score the lower the quality of life

  baseline, week 52

Secondary Outcomes (14)

• Changes in the Movement Disorder Society Unified Parkinson's Disease Rating Scale part II (MDS-UPDRS Part II)

  baseline, week 52

• Changes in the Movement Disorder Society Unified Parkinson's Disease Rating Scale part IV (MDS-UPDRS part IV)

  baseline, week 52

• Changes in the Non-Motor Symptoms Scale score (NMSS)

  baseline, week 52

• Changes in Unified Multiple System Atrophy Rating Scale (UMSARS)

  baseline, week 52

• Changes in Progressive Supranuclear Palsy Rating Scale (PSPRS)

  baseline, week 52

Study Arms (2)

Telemonitoring

EXPERIMENTAL

Patients are followed up by a nurse-telemonitoring

Other: Telemonitoring

Standard-of-care

ACTIVE COMPARATOR

Patients are followed up only by the neurologist

Other: Standard-of-care

Interventions

Telemonitoring OTHER

Patients are followed up by a nurse specialist in parkinsonism who interacts with the treating neurologist and a multidisciplinary team

Telemonitoring

Standard-of-care OTHER

Patients are managed only by the neurologist according the institution's clinical practice

Standard-of-care

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta: lead
• Fondazione Mondino: collaborator
• Neuromed IRCCS: collaborator
• Azienda Ospedaliera Universitaria Policlinico "G. Martino": collaborator

Study Sites (4)

Azienda Ospedaliera Universitaria Gaetano Martino

Messina, Italy

Location

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, 20133, Italy

Location

Fondazione IRCCS Istituto Neurologico Nazionale Casmiro Mondino

Pavia, Italy

Location

IRCCS Neuromed

Pozzilli, Italy

Location

Related Publications (16)

• van der Marck MA, Bloem BR, Borm GF, Overeem S, Munneke M, Guttman M. Effectiveness of multidisciplinary care for Parkinson's disease: a randomized, controlled trial. Mov Disord. 2013 May;28(5):605-11. doi: 10.1002/mds.25194. Epub 2012 Nov 19.

  PMID: 23165981 BACKGROUND

• Huse DM, Schulman K, Orsini L, Castelli-Haley J, Kennedy S, Lenhart G. Burden of illness in Parkinson's disease. Mov Disord. 2005 Nov;20(11):1449-54. doi: 10.1002/mds.20609.

  PMID: 16007641 BACKGROUND

• Gerlach OH, Broen MP, van Domburg PH, Vermeij AJ, Weber WE. Deterioration of Parkinson's disease during hospitalization: survey of 684 patients. BMC Neurol. 2012 Mar 8;12:13. doi: 10.1186/1471-2377-12-13.

  PMID: 22400982 BACKGROUND

• Muzerengi S, Herd C, Rick C, Clarke CE. A systematic review of interventions to reduce hospitalisation in Parkinson's disease. Parkinsonism Relat Disord. 2016 Mar;24:3-7. doi: 10.1016/j.parkreldis.2016.01.011. Epub 2016 Jan 13.

  PMID: 26803377 BACKGROUND

• Hassan A, Wu SS, Schmidt P, Dai Y, Simuni T, Giladi N, Bloem BR, Malaty IA, Okun MS; NPF-QII Investigators. High rates and the risk factors for emergency room visits and hospitalization in Parkinson's disease. Parkinsonism Relat Disord. 2013 Nov;19(11):949-54. doi: 10.1016/j.parkreldis.2013.06.006. Epub 2013 Jul 5.

  PMID: 23835430 BACKGROUND

• Jenkinson C, Fitzpatrick R, Peto V, Greenhall R, Hyman N. The Parkinson's Disease Questionnaire (PDQ-39): development and validation of a Parkinson's disease summary index score. Age Ageing. 1997 Sep;26(5):353-7. doi: 10.1093/ageing/26.5.353.

  PMID: 9351479 BACKGROUND

• Hagell P, Alvariza A, Westergren A, Arestedt K. Assessment of Burden Among Family Caregivers of People With Parkinson's Disease Using the Zarit Burden Interview. J Pain Symptom Manage. 2017 Feb;53(2):272-278. doi: 10.1016/j.jpainsymman.2016.09.007. Epub 2016 Nov 1.

  PMID: 27810571 BACKGROUND

• Miller MD, Paradis CF, Houck PR, Mazumdar S, Stack JA, Rifai AH, Mulsant B, Reynolds CF 3rd. Rating chronic medical illness burden in geropsychiatric practice and research: application of the Cumulative Illness Rating Scale. Psychiatry Res. 1992 Mar;41(3):237-48. doi: 10.1016/0165-1781(92)90005-n.

  PMID: 1594710 BACKGROUND

• Schrag A, Selai C, Jahanshahi M, Quinn NP. The EQ-5D--a generic quality of life measure-is a useful instrument to measure quality of life in patients with Parkinson's disease. J Neurol Neurosurg Psychiatry. 2000 Jul;69(1):67-73. doi: 10.1136/jnnp.69.1.67.

  PMID: 10864606 BACKGROUND

• Fabbrini G, Abbruzzese G, Barone P, Antonini A, Tinazzi M, Castegnaro G, Rizzoli S, Morisky DE, Lessi P, Ceravolo R; REASON study group. Adherence to anti-Parkinson drug therapy in the "REASON" sample of Italian patients with Parkinson's disease: the linguistic validation of the Italian version of the "Morisky Medical Adherence Scale-8 items". Neurol Sci. 2013 Nov;34(11):2015-22. doi: 10.1007/s10072-013-1438-1. Epub 2013 Jun 1.

  PMID: 23728715 BACKGROUND

• Wenning GK, Stankovic I, Vignatelli L, Fanciulli A, Calandra-Buonaura G, Seppi K, Palma JA, Meissner WG, Krismer F, Berg D, Cortelli P, Freeman R, Halliday G, Hoglinger G, Lang A, Ling H, Litvan I, Low P, Miki Y, Panicker J, Pellecchia MT, Quinn N, Sakakibara R, Stamelou M, Tolosa E, Tsuji S, Warner T, Poewe W, Kaufmann H. The Movement Disorder Society Criteria for the Diagnosis of Multiple System Atrophy. Mov Disord. 2022 Jun;37(6):1131-1148. doi: 10.1002/mds.29005. Epub 2022 Apr 21.

  PMID: 35445419 BACKGROUND

• Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051.

  PMID: 16129869 BACKGROUND

• Borzi L, Mazzetta I, Zampogna A, Suppa A, Irrera F, Olmo G. Predicting Axial Impairment in Parkinson's Disease through a Single Inertial Sensor. Sensors (Basel). 2022 Jan 6;22(2):412. doi: 10.3390/s22020412.

  PMID: 35062375 BACKGROUND

• 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 Jun;75:130-132. doi: 10.1016/j.parkreldis.2020.05.038. Epub 2020 Jun 10.

  PMID: 32723588 BACKGROUND

• Lennaerts H, Groot M, Rood B, Gilissen K, Tulp H, van Wensen E, Munneke M, van Laar T, Bloem BR. A Guideline for Parkinson's Disease Nurse Specialists, with Recommendations for Clinical Practice. J Parkinsons Dis. 2017;7(4):749-754. doi: 10.3233/JPD-171195.

  PMID: 28800338 RESULT

• Cilia R, Colucci F, Suppa A, Valentino F, Terranova C, Leuzzi C, Cordasco J, Fusi G, Floridia S, De Giorgi F, Telese R, Braccia A, Zampogna A, Pinola G, Patera M, Belluscio G, Crivellari S, Antoniazzi E, Cascino S, Giaco A, Masaracchio A, Moreschi GC, Catotti M, Eleopra R. Integrated management of atypical parkinsonism: a home-based patient-centered healthcare delivery based on telenursing-the IMPACT study protocol. Ther Adv Neurol Disord. 2025 Apr 3;18:17562864241299347. doi: 10.1177/17562864241299347. eCollection 2025.

  PMID: 40190837 DERIVED

MeSH Terms

Conditions

Shy-Drager Syndrome

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Multiple System Atrophy; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Hypotension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Roberto Eleopra, MD

  Study Principal Investigator Fondazione IRCCS Istituto Neurologico Carlo Besta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: March 31, 2023
• Study Start: August 17, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis
• Access Criteria: Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan and execution of a Data Sharing Agreement. For more information or to submit a request, please contact crc@istituto-besta.it

Locations

IT (4)