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

December 22, 2023 updated by: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Estimated)

164

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Messina, Italy
        • Recruiting
        • Azienda Ospedaliera Universitaria Gaetano Martino
        • Contact:
          • Carmen Terranova
      • Milan, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto Neurologico Carlo Besta
        • Contact:
      • Pavia, Italy
        • Recruiting
        • Fondazione IRCCS Istituto Neurologico Nazionale Casmiro Mondino
        • Contact:
          • Francesca Valentino, MD
      • Pozzilli, Italy
        • Recruiting
        • IRCCS Neuromed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard-of-care
Patients are followed up only by the neurologist
Other: Standard-of-care
Patients are managed only by the neurologist according the institution's clinical practice
Experimental: Telemonitoring
Patients are followed up by a nurse-telemonitoring
Other: Telemonitoring
Patients are followed up by a nurse specialist in parkinsonism who interacts with the treating neurologist and a multidisciplinary team

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in total score of the Parkinson's Disease Questionnaire 39-items scale (PDQ-39)
Time Frame: baseline, week 52
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the Movement Disorder Society Unified Parkinson's Disease Rating Scale part II (MDS-UPDRS Part II)
Time Frame: baseline, week 52
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
baseline, week 52
Changes in the Movement Disorder Society Unified Parkinson's Disease Rating Scale part IV (MDS-UPDRS part IV)
Time Frame: baseline, week 52
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
baseline, week 52
Changes in the Non-Motor Symptoms Scale score (NMSS)
Time Frame: baseline, week 52
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
baseline, week 52
Changes in Unified Multiple System Atrophy Rating Scale (UMSARS)
Time Frame: baseline, week 52
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
baseline, week 52
Changes in Progressive Supranuclear Palsy Rating Scale (PSPRS)
Time Frame: baseline, week 52
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
baseline, week 52
Changes in the activities of daily living questionnaire (ADL_questionnaire)
Time Frame: baseline, week 52
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
baseline, week 52
Changes in the intrumental activities of daily living questionnaire (IADL)
Time Frame: baseline, week 52
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
baseline, week 52
Changes in the Zarit Burden Interview scale score (ZBI)
Time Frame: baseline, week 52
This is a scale used to investigate caregiver's burnout. Total score is 0-40. The higher the score the worse the disability
baseline, week 52
Number of unplanned hospital admission
Time Frame: week 52
Sum of number of outpatients departments assessments, number of emergency rooms accesses, number of unplanned hospitalizations
week 52
Number of incident comorbidities
Time Frame: baseline, week 52
The number of incident comorbidities over the 12.month study period will be assessed using a semistructured interview
baseline, week 52
Changes in Euro Quality Of Life Dimensions-5 Levels score (EuroQOL-5)
Time Frame: baseline, week 52
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.
baseline, week 52
Changes in patient experience questionnaire (EQ)
Time Frame: baseline, week 26, week 52
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
baseline, week 26, week 52
Changes in freezing of walking, Freezing of gait-questionnaire (FOG-Q)
Time Frame: baseline, week 52
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
baseline, week 52
Changes in the Morisky Medical Adherence scale-8 items score (MMAS)
Time Frame: baseline, week 26, week 52
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.
baseline, week 26, week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Collaborators

Neuromed IRCCS
Fondazione IRCCS Istituto Neurologico Nazionale Casmiro Mondino
Azienda Ospedaliera Universitaria Gaetano Martino, Messina

Investigators

  • Principal Investigator: Roberto Eleopra, MD, Study Principal Investigator Fondazione IRCCS Istituto Neurologico Carlo Besta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 17, 2023

Primary Completion (Estimated)

April 15, 2025

Study Completion (Estimated)

May 15, 2025

Study Registration Dates

First Submitted

February 24, 2023

First Submitted That Met QC Criteria

March 18, 2023

First Posted (Actual)

March 31, 2023

Study Record Updates

Last Update Posted (Actual)

December 26, 2023

Last Update Submitted That Met QC Criteria

December 22, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMPACT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing 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

IPD Sharing 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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