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

NCT ID: NCT05792332

Last Updated: 2024-11-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-17
• Study Completion Date: 2025-05-15

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)

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Telemonitoring

Patients are followed up by a nurse-telemonitoring

Group Type: EXPERIMENTAL

Telemonitoring

Intervention Type: OTHER

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

Standard-of-care

Patients are followed up only by the neurologist

Group Type: ACTIVE_COMPARATOR

Standard-of-care

Intervention Type: OTHER

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

Interventions

Telemonitoring

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

Intervention Type: OTHER

Standard-of-care

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Mondino

OTHER

Sponsor Role: collaborator

Neuromed IRCCS

OTHER

Sponsor Role: collaborator

Azienda Ospedaliera Universitaria Policlinico "G. Martino"

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roberto Eleopra, MD

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator Fondazione IRCCS Istituto Neurologico Carlo Besta

Locations

Azienda Ospedaliera Universitaria Gaetano Martino

Messina, , Italy

Site Status: RECRUITING

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, , Italy

Site Status: RECRUITING

Fondazione IRCCS Istituto Neurologico Nazionale Casmiro Mondino

Pavia, , Italy

Site Status: RECRUITING

IRCCS Neuromed

Pozzilli, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Roberto Cilia, MD

Role: CONTACT

neuro1@istituto-besta.it

(+39)0223941 ext. 2552

Clinical Research Center, CRC

Role: CONTACT

crc@istituto-besta.it

(+39)0223941 ext. 3568

Facility Contacts

Carmen Terranova

Role: primary

Roberto Cilia, MD

Role: primary

roberto.cilia@istitutobesta.it

(+39)0223941 ext. 2552

Francesca Valentino, MD

Role: primary

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Other Identifiers

IMPACT

Identifier Type: -

Identifier Source: org_study_id