Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04378127
Enrollment
120
Registered
2020-05-07
Start date
2015-05-10
Completion date
2018-12-10
Last updated
2024-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

parkinson disease, burden, caregiver, educational program

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.

Interventions

OTHEREducational 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.

Sponsors

IRCCS San Raffaele Roma
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

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

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
OFF hoursthrough study completion, an average of 1 yearThe 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026