Mister Parkinson: Educational Therapy in Parkinson's Disease (PD)

Educational Therapy in Parkinson's Disease (PD): A Non-pharmacological Interventional, Multicentric, Randomized Controlled Trial.

Parkinson's disease is multidimensional disorders characterized by motor and non-motor symptoms such as behavioral and psychological symptoms, autonomic disturbances and other non-motor symptoms. These can contribute to the burden of the disease on patients and their caregivers, and often remain unrecognized and untreated.

This was a single-blind,multicentric, prospective, randomized study comparing two arms: an intervention group undergoing a structured educational program associated to standard care and a control group who solely continued with traditional medical care.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: Educational program

Detailed Description

Parkinson's disease is multidimensional disorders characterized by motor and non-motor symptoms such as behavioral and psychological symptoms, autonomic disturbances and other non-motor symptoms. A multidisciplinary and comprehensive approach, based on the chronic care model, is considered the best way to manage motor and non-motor symptoms of the disease, although this model of care is still not standardized and previous trials showed conflicting results.

The study planned to enrol 40 advanced PD patients and related caregivers for each investigational site. This was a single-blind,multicentric, prospective, randomized study comparing two arms: an intervention group undergoing a structured educational program associated to standard care and a control group who solely continued with traditional medical care.

The educational program consisted of six thematic meetings of 3 hours each, which a 15-minute interval every hour. Each meeting had a key topic and was divided in a teaching session and in a practical session with individual training of both, subject and caregiver. Every lecture was held by a movement disorders specialist with particular expertise in each field of discussion and the content of each lessons (slides, flyers, questionnaires) was adapted to fit the audience.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• idiopathic Parkinson's disease (according to UK Brain Bank criteria)
• being aged 20-80 years
• being able to complete questionnaires
• having no severe cognitive impairment (mini-mental state examination ≥24)
• having a stable caregiver

Exclusion Criteria:

• atypical parkinsonian
• severe comorbidity significantly interfering with quality of life

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: educational program + traditional medical care; The educational program consisted of six thematic meetings of 3 hours each, which a 15-minute interval every hour. Each meeting had a key topic and was divided in a teaching session and in a practical session with individual training of both, subject and caregiver. Every lecture was held by a movement disorders specialist with particular expertise in each field of discussion and the content of each lessons (slides, flyers, questionnaires) was adapted to fit the audience.	Other: Educational program; The educational program consisted of six thematic meetings of 3 hours each, which a 15-minute interval every hour. Each meeting had a key topic and was divided in a teaching session and in a practical session with individual training of both, subject and caregiver. Every lecture was held by a movement disorders specialist with particular expertise in each field of discussion and the content of each lessons (slides, flyers, questionnaires) was adapted to fit the audience.
No Intervention: traditional medical care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OFF hours	The primary outcome was change from baseline to end of study in the mean daily OFF hours evaluated with the Hauser diary. Expected increase in the mean time spent in ON in at least 50% of treated patients (OR ≥1.5) compared to the control group.	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele Roma
• Investigators: Principal Investigator: fabrizio stocchi, md phd, IRCCS San Raffaele

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2015
• Primary Completion (Actual): December 10, 2018
• Study Completion (Actual): December 10, 2018

Study Registration Dates

• First Submitted: May 4, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (Actual): May 7, 2020

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: educational program; caregiver; burden; parkinson disease
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: MisterParkinson

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: after the end of sudy
• IPD Sharing Time Frame: after the end of study
• IPD Sharing Access Criteria: request by email
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No