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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04378127
• Other study ID #: MisterParkinson
• Status: Completed
• Phase: N/A
• Start date: May 10, 2015
• Est. completion date: December 10, 2018

Study information

• Verified date: October 2022
• Source: IRCCS San Raffaele Roma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 10, 2018
• Est. primary completion date: December 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele Roma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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