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

Study Overview
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Brief Summary
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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
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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)

Official Title
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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

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

Intervention / Treatment
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* Other: Telemonitoring
* Other: Standard-of-care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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 | Sum of number of outpatients departments assessments, number of emergency rooms accesses, number of unplanned hospitalizations | week 52 | 
| Number of incident comorbidities | 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) | 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 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. | baseline, week 26, week 52 | 
| 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 | baseline, week 26, week 52 | 
| 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 | baseline, week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PSP, MSA, Atypical parkinsonism, Nurse Specialist