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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Parkinson Disease

Intervention / Treatment
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* Other: Educational program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: educational program + traditional medical care<br>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<br>* 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.<br>|
| No Intervention: traditional medical care<br>traditional medical care | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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burden, parkinson disease, caregiver, educational program