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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05792332
Other study ID # IMPACT
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 17, 2023
Est. completion date May 15, 2025

Study information

Verified date May 2023
Source Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Contact Roberto Cilia, MD
Phone (+39)0223941
Email neuro1@istituto-besta.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Description:

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Study Design


Intervention

Other:
Telemonitoring
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 managed only by the neurologist according the institution's clinical practice

Locations

Country Name City State
Italy Azienda Ospedaliera Universitaria Gaetano Martino Messina
Italy Fondazione IRCCS Istituto Neurologico Carlo Besta Milan
Italy Fondazione IRCCS Istituto Neurologico Nazionale Casmiro Mondino Pavia
Italy IRCCS Neuromed Pozzilli

Sponsors (4)

Lead Sponsor Collaborator
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta Azienda Ospedaliera Universitaria Gaetano Martino, Messina, Fondazione IRCCS Istituto Neurologico Nazionale Casmiro Mondino, Neuromed IRCCS

Country where clinical trial is conducted

Italy, 

References & Publications (15)

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Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Number of unplanned hospital admission Sum of number of outpatients departments assessments, number of emergency rooms accesses, number of unplanned hospitalizations week 52
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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