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Atypical ParkinsonismNCT05792332

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

A study testing Telemonitoring and Standard-of-care in people with Atypical Parkinsonism and MSA - Multiple System Atrophy, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 4 sites in Italy.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 85 years
What is being tested?
Telemonitoring and Standard-of-care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
164 participants
Where
4 sitesItaly
Study dates
17 Aug 2023to Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country.

Italy4 sites

  • Azienda Ospedaliera Universitaria Gaetano Martino

    Messina

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    Milan, 20133

  • Fondazione IRCCS Istituto Neurologico Nazionale Casmiro Mondino

    Pavia

  • IRCCS Neuromed

    Pozzilli

Other trials in Italy

About this study

Official title: 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 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

Read the detailed description

People with parkinsonism experience a wide range of motor and non-motor disorders associated with the increasing complexity of care delivery and the increased risk of complications with increased hospital access. Although a number of multidisciplinary care models have been proposed so far, results have been disappointing in terms of benefit in quality of life and cost-effectiveness. An integrated remote care model at home, involving a parkinsonism nurse specialist (PKNS) as well as a movement disorder specialist, could offer significant benefits to patients and healthcare professionals through better health education, continuity of care and more careful monitoring of the complications of the accident. In this multicenter, randomized, single-blinded, case-control trial, the investigators will recruit 164 patients with atypical parkinsonism (either MSA or PSP) to investigate the efficacy and cost-effectiveness of a 12-month remote home-based integrated program to improve healthcare delivery, coordinated by a specialized nurse (case manager) compared to standard medical care. This organizational model of personalized medicine aims to simplify, standardize and improve patient care and monitoring over time, including remote management of situations of urgency. This telenursing program consists of both proactive and reactive monitoring approaches acting synergistically to optimize the continuity of care by tertiary expert movement disorders clinics. In proactive monitoring, patients are contacted at baseline (to create a patient record focused on identifying individual-specific vulnerabilities) and then every 3 months. During the 12-month study period, patients and caregivers may contact the case manager in case of any problems (reactive monitoring), who may: (a) deal with the specific problem also by interacting with the participant's general practitioner and other healthcare professionals (e.g. physical therapist, psychologist, nutritionist, occupational therapist, social worker, etc) or (b) refer to the neurologist for teleconsultation or in-person visit according to a semi-structured algorithm, which assigns 4 levels of priority. Participants will be evaluated with clinical scales testing the quality of life, motor and non-motor symptoms, caregiver burden, adherence to therapy, cumulative disease burden and the number of unscheduled hospital access during the study period. The cost-effectiveness of this method will also be evaluated by using the EuroQoL, which will estimate the incremental cost per quality-adjusted life-years (QALY) gain. Finally, the investigators will assess the feasibility and utility of Telemonitoring to guide decisionmaking by using a waist-worn wearable (STAT-ONTM) to monitor real-life motor autonomy and the risk of falls, including freezing of gait for 5 consecutive days every month during the 12-month duration of the study. If successful, this low-cost integrated management of patients with atypical parkinsonism may be extended to people with the more prevalent Parkinson's disease as well as other neurodegenerative disorders (e.g. Alzheimer's dementia)

Being tested
Telemonitoring, Standard-of-care
Keywords
Atypical parkinsonism, Nurse Specialist, MSA, PSP
Medical subject headings
Shy-Drager Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TelemonitoringOther

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

  • Standard-of-careOther

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

Study groups in NCT05792332
Study groupRoleWhat they receive
TelemonitoringExperimentalPatients are followed up by a nurse-telemonitoring
Receives: Other: Telemonitoring
Standard-of-careActive comparatorPatients are followed up only by the neurologist
Receives: Other: Standard-of-care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: baseline, week 52

Secondary outcomes (14)

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

    This is a scale (MDS-UPDRS Part II) used to assess activities of daily living. Score ranges from 0 to 52. The higher the score the worse the Disability

    Measured: baseline, week 52

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

    This is a scale (MDS-UPDRS part IV) used to assess complications of dopaminergic therapy. Score ranges from 0 to 24. The higher the score the worse the disability

    Measured: baseline, week 52

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

    This is a scale used to assess the burden of non-motor symptoms in Parkinson's disease. Total score is 0-360. The higher the score the worse the disability

    Measured: baseline, week 52

  4. Changes in Unified Multiple System Atrophy Rating Scale (UMSARS)

    This scale (UMSARS) is used to assess disease progression in multiple system atrophy.The score is from 0 up to 109. The higher the score the worse the disability

    Measured: baseline, week 52

  5. Changes in Progressive Supranuclear Palsy Rating Scale (PSPRS)

    This scale (PSPRS) is used to assess disease progression in Progressive Supranuclear Palsy. The total score is 0-100. The higher the score the worse the disability

    Measured: baseline, week 52

  6. Changes in the activities of daily living questionnaire (ADL_questionnaire)

    The "ADL (Activities of Daily Living)" evaluation refers to the fundamental activities of daily life in which the subject is dependent: on a scale from 0 to 6 points, the lower the score, the greater the person's need for assistance

    Measured: baseline, week 52

  7. Changes in the intrumental activities of daily living questionnaire (IADL)

    The "IADL (Instrumental Activities of Daily Living)" evaluation refers to the instrumental activities of daily life in which the subject is dependent (eg using telephone, preparing meals, taking medications, etc): on a scale from 0 to 8 points, the lower the score, the greater the person's need for assistance

    Measured: baseline, week 52

  8. Changes in the Zarit Burden Interview scale score (ZBI)

    This is a scale used to investigate caregiver's burnout. Total score is 0-40. The higher the score the worse the disability

    Measured: baseline, week 52

  9. Number of unplanned hospital admission

    Sum of number of outpatients departments assessments, number of emergency rooms accesses, number of unplanned hospitalizations

    Measured: week 52

  10. Number of incident comorbidities

    The number of incident comorbidities over the 12.month study period will be assessed using a semistructured interview

    Measured: baseline, week 52

  11. Changes in Euro Quality Of Life Dimensions-5 Levels score (EuroQOL-5)

    This is a useful and validated instrument to measure quality of life in patients with Parkinson's disease. The patient select a score from 0 to 100. The lowest the score the lowest quality of life.

    Measured: baseline, week 52

  12. Changes in the Morisky Medical Adherence scale-8 items score (MMAS)

    This is an 8-items scale used to investigate patient adherence to the therapy prescribed by the MD specialist. Score is 0-8 "yes" answer. The 3 categorical Likert Scale is: low adherence <6; medium adherence 6-8; high adherence 8.

    Measured: baseline, week 26, week 52

  13. Changes in patient experience questionnaire (EQ)

    This is a questionnaire assessing patient perception and satisfaction of the quality of health care. Total score is 0-100. The highest the score, the worst the satisfaction

    Measured: baseline, week 26, week 52

  14. Changes in freezing of walking, Freezing of gait-questionnaire (FOG-Q)

    Changes in gait performances, mainly in freezing of walking, are analysis by this questionnaire. Total score is 0-24. The highest the score, the highest the freezing

    Measured: baseline, week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2023
  2. Study start17 Aug 2023
  3. Primary completionJun 2026 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
164 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05792332
Sponsor's protocol ID
IMPACT
Status last verified
Mar 2026
First submitted
24 Feb 2023
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data obtained through this study may be provided to qualified researchers with academic interest on this topic. Data shared will be coded, with no protected health information included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party

Publications

  • 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.

    PubMed 23165981

  • 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.

    PubMed 16007641

  • 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.

    PubMed 22400982

  • 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.

    PubMed 26803377

  • 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.

    PubMed 23835430

  • 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.

    PubMed 9351479

  • 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.

    PubMed 27810571

  • 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.

    PubMed 1594710

  • 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.

    PubMed 10864606

  • 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.

    PubMed 23728715

  • 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.

    PubMed 35445419

  • 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.

    PubMed 16129869

  • 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.

    PubMed 35062375

  • 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.

    PubMed 32723588

  • 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.

    PubMed 28800338

Questions about this trial

What is this clinical trial studying?

A study testing Telemonitoring and Standard-of-care in people with Atypical Parkinsonism and MSA - Multiple System Atrophy, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 4 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in total score of the Parkinson's Disease Questionnaire 39-items scale (PDQ-39) (time frame: baseline, week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05792332, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.

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