Education in Therapy of Parkinson's Disease

Study Overview
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Brief Summary
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Parkinson's disease (PD) has considerable impact on motor, psychological and social activities and significantly affects the quality of life of patients and their families. To improve the medical care of PD patients, the investigator have developed an educational program specific to PD. The principal aim of this study is to evaluate the therapeutic education Program, comparing the quality of life of PD patients with or without the educational program after six month and one year follow-up. The secondary aims are to evaluate the evolution of motor and psychological states in these 2 groups of patients and to compare the medical costs. This is a monocentric, comparative, prospective randomised study. The investigators will evaluate 120 PD patients, 60 patients benefiting of the educational program and 60 patients with a traditional medical care. Quality of life of PD patients is evaluated using a specific scale (PDQ39) and a generalist scale (SF36) at 6 and 12 months. Motor and psychological states were assessed with UPDRS and HAD Scales. The educational program consisted of both individual and collective educational consultations. The investigators supposed that the therapeutic education program will improve the quality of life of PD patients. The supposition that this improvement will correlate with the motor and psychological states.

Official Title
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EVALUATION OF A THERAPEUTIC EDUCATION PROGRAMME IN PARKINSON'S DISEASE

Conditions
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Parkinson Disease

Intervention / Treatment
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* Behavioral: therapeutic education program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with clinical diagnosis of Parkinson's disease according to the criteria of the UKPDSBB Parkinson's disease patients with a score ≤4 on the Hoehn and Year scale Patient without cognitive disorders Patients treated with dopaminergic antiparkisonian drugs (L-DOPA, dopamine agonists,ICOMT…) or DBS stimulation (since at least 3 month) Patients able to fulfil self-administered questionnaire Patients affiliated to a social protection program Exclusion Criteria: - Patients suffering from an other pathology causing chronic pain (rheumatic disease, traumatic or orthopaedic pathologies…) Parkinson's disease patients with a score>5 on the Hoehn and Yahr scale Patients suffering of parkinsonism induce by drugs Patients with important tremors during a OFF conditions Patients ever included in another study Patients with severe psychiatric disease Patients under tutelage, curatelle or law protection Patients included in an other clinical study Patients unable to fulfil scales of the study

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: traditional medical care<br>patients benefiting of a traditional medical care | |
| Experimental: therapeutic education program<br>The educational program consisted of both individual and collective educational consultations with a therapeutic education nurse | Behavioral: therapeutic education program<br>* The educational program consisted of both individual and collective educational consultations with a therapeutic education nurse<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life with the PDQ39 scale |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life with the SF36 scale |  | 1 year | 
| the motor state with UPDRS (Unified Pakinson's disease Rating Scale) |  | 1 year | 
| The psychological state with HAD (Hospital Anxiety and Depression) scale |  | 1 year | 
| Evaluation of social adaptation with SAS-SR (Social adjustement Scale Sel-Report) scale |  | 1 year | 
| Evaluation of medical costs |  | over the 12 months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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therapeutic education, Parkinson's disease, quality of life