Education in Therapy of Parkinson's Disease
ETPARK
EVALUATION OF A THERAPEUTIC EDUCATION PROGRAMME IN PARKINSON'S DISEASE
1 other identifier
interventional
120
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable parkinson-disease
Started Dec 2008
Typical duration for not_applicable parkinson-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 22, 2012
CompletedFirst Posted
Study publicly available on registry
October 30, 2012
CompletedMay 12, 2017
May 1, 2017
Same day
October 22, 2012
May 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quality of life with the PDQ39 scale
1 year
Secondary Outcomes (5)
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
Study Arms (2)
traditional medical care
NO INTERVENTIONpatients benefiting of a traditional medical care
therapeutic education program
EXPERIMENTALThe educational program consisted of both individual and collective educational consultations with a therapeutic education nurse
Interventions
The educational program consisted of both individual and collective educational consultations with a therapeutic education nurse
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UH Toulouse
Toulouse, 31000, France
Related Publications (1)
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.
PMID: 24267951RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2012
First Posted
October 30, 2012
Study Start
December 1, 2008
Primary Completion
December 1, 2008
Study Completion
April 1, 2011
Last Updated
May 12, 2017
Record last verified: 2017-05