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

Sponsor

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05792332

Collaborator

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

164

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Atypical Parkinsonism MSA - Multiple System Atrophy PSP Nurse-Patient Relations Nurse Physician Relations	Other: Telemonitoring Other: Standard-of-care	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

164 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

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

Anticipated Study Start Date :

May 15, 2023

Anticipated Primary Completion Date :

Apr 15, 2025

Anticipated Study Completion Date :

May 15, 2025

Arms and Interventions

Arm	Intervention/Treatment
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
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

Arm

Intervention/Treatment

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Azienda Ospedaliera Universitaria Gaetano Martino	Messina	Italy
2	Fondazione IRCCS Istituto Neurologico Carlo Besta	Milan	Italy	20133
3	Fondazione IRCCS Istituto Neurologico Nazionale Casmiro Mondino	Pavia	Italy
4	IRCCS Neuromed	Pozzilli	Italy