Clinical trial NCT04378127: Mister Parkinson: Educational Therapy in Parkinson's Disease (PD)
Official title: Educational Therapy in Parkinson's Disease (PD): A Non-pharmacological Interventional, Multicentric, Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: parkinson disease
burden
caregiver
educational program
Lead sponsor: IRCCS San Raffaele Roma
Sponsor class: OTHER
First posted: 2020-05-07
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: OFF hours
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: IRCCS San Raffaele
name: fabrizio stocchi, md phd
role: PRINCIPAL_INVESTIGATOR
References: