Education in Therapy of Parkinson's Disease (ETPARK)
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
therapeutic education program
Sponsored by
About this trial
This is an interventional basic science trial for Parkinson Disease focused on measuring therapeutic education, Parkinson's disease, quality of life
Eligibility Criteria
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
Sites / Locations
- UH Toulouse
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
traditional medical care
therapeutic education program
Arm Description
patients benefiting of a traditional medical care
The educational program consisted of both individual and collective educational consultations with a therapeutic education nurse
Outcomes
Primary Outcome Measures
Quality of life with the PDQ39 scale
Secondary Outcome Measures
Quality of life with the SF36 scale
the motor state with UPDRS (Unified Pakinson's disease Rating Scale)
The psychological state with HAD (Hospital Anxiety and Depression) scale
Evaluation of social adaptation with SAS-SR (Social adjustement Scale Sel-Report) scale
Evaluation of medical costs
Full Information
NCT ID
NCT01717144
First Posted
October 22, 2012
Last Updated
May 10, 2017
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT01717144
Brief Title
Education in Therapy of Parkinson's Disease
Acronym
ETPARK
Official Title
EVALUATION OF A THERAPEUTIC EDUCATION PROGRAMME IN PARKINSON'S DISEASE
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
therapeutic education, Parkinson's disease, quality of life
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
traditional medical care
Arm Type
No Intervention
Arm Description
patients benefiting of a traditional medical care
Arm Title
therapeutic education program
Arm Type
Experimental
Arm Description
The educational program consisted of both individual and collective educational consultations with a therapeutic education nurse
Intervention Type
Behavioral
Intervention Name(s)
therapeutic education program
Intervention Description
The educational program consisted of both individual and collective educational consultations with a therapeutic education nurse
Primary Outcome Measure Information:
Title
Quality of life with the PDQ39 scale
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Quality of life with the SF36 scale
Time Frame
1 year
Title
the motor state with UPDRS (Unified Pakinson's disease Rating Scale)
Time Frame
1 year
Title
The psychological state with HAD (Hospital Anxiety and Depression) scale
Time Frame
1 year
Title
Evaluation of social adaptation with SAS-SR (Social adjustement Scale Sel-Report) scale
Time Frame
1 year
Title
Evaluation of medical costs
Time Frame
over the 12 months follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
UH Toulouse
City
Toulouse
ZIP/Postal Code
31000
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
24267951
Citation
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.
Results Reference
result
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Education in Therapy of Parkinson's Disease
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