Clinical trial NCT05792332: Integrated Management of Atypical Parkinsonism: A Home-based Patient-Centered Healthcare Delivery Based on Telenursing (IMPACT 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atypical Parkinsonism
MSA - Multiple System Atrophy
PSP
Nurse-Patient Relations
Nurse Physician Relations
Keywords: Atypical parkinsonism
Nurse Specialist
MSA
PSP
Lead sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Sponsor class: OTHER
Collaborators: name: Fondazione Mondino
name: Neuromed IRCCS
name: Azienda Ospedaliera Universitaria Gaetano Martino, Messina
First posted: 2023-03-31
Enrollment: 164
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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)

Eligibility 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

Primary outcomes:
measure: Changes in total score of the Parkinson's Disease Questionnaire 39-items scale (PDQ-39)
timeFrame: baseline, week 52
Secondary outcomes:
measure: Changes in the Movement Disorder Society Unified Parkinson's Disease Rating Scale part II (MDS-UPDRS Part II)
timeFrame: baseline, week 52
measure: Changes in the Movement Disorder Society Unified Parkinson's Disease Rating Scale part IV (MDS-UPDRS part IV)
timeFrame: baseline, week 52
measure: Changes in the Non-Motor Symptoms Scale score (NMSS)
timeFrame: baseline, week 52
measure: Changes in Unified Multiple System Atrophy Rating Scale (UMSARS)
timeFrame: baseline, week 52
measure: Changes in Progressive Supranuclear Palsy Rating Scale (PSPRS)
timeFrame: baseline, week 52
measure: Changes in the activities of daily living questionnaire (ADL_questionnaire)
timeFrame: baseline, week 52
measure: Changes in the intrumental activities of daily living questionnaire (IADL)
timeFrame: baseline, week 52
measure: Changes in the Zarit Burden Interview scale score (ZBI)
timeFrame: baseline, week 52
measure: Number of unplanned hospital admission
timeFrame: week 52
measure: Number of incident comorbidities
timeFrame: baseline, week 52
measure: Changes in Euro Quality Of Life Dimensions-5 Levels score (EuroQOL-5)
timeFrame: baseline, week 52
measure: Changes in the Morisky Medical Adherence scale-8 items score (MMAS)
timeFrame: baseline, week 26, week 52
measure: Changes in patient experience questionnaire (EQ)
timeFrame: baseline, week 26, week 52
measure: Changes in freezing of walking, Freezing of gait-questionnaire (FOG-Q)
timeFrame: baseline, week 52
Other outcomes:
Locations:
city: Messina
country: Italy
facility: Azienda Ospedaliera Universitaria Gaetano Martino
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Neurologico Carlo Besta
city: Pavia
country: Italy
facility: Fondazione IRCCS Istituto Neurologico Nazionale Casmiro Mondino
city: Pozzilli
country: Italy
facility: IRCCS Neuromed
Study officials:
affiliation: Study Principal Investigator Fondazione IRCCS Istituto Neurologico Carlo Besta
name: Roberto Eleopra, MD
role: PRINCIPAL_INVESTIGATOR
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