Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2008-12-31
2011-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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traditional medical care
patients benefiting of a traditional medical care
No interventions assigned to this group
therapeutic education program
The educational program consisted of both individual and collective educational consultations with a therapeutic education nurse
therapeutic education program
The educational program consisted of both individual and collective educational consultations with a therapeutic education nurse
Interventions
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therapeutic education program
The educational program consisted of both individual and collective educational consultations with a therapeutic education nurse
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
30 Years
75 Years
ALL
No
Sponsors
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University Hospital, Toulouse
OTHER
Responsible Party
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Locations
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UH Toulouse
Toulouse, , France
Countries
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References
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Ory Magne F, Arcari C, Canivet C, Sarrail M, Fabre MH, Mohara C, Brefel Courbon C. [A therapeutic educational program in Parkinson's disease: ETPARK]. Rev Neurol (Paris). 2014 Feb;170(2):128-33. doi: 10.1016/j.neurol.2013.08.007. Epub 2013 Nov 20. French.
Other Identifiers
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08 150 07
Identifier Type: -
Identifier Source: org_study_id
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