Clinical trial NCT01717144: Education in Therapy of Parkinson's Disease
Official title: EVALUATION OF A THERAPEUTIC EDUCATION PROGRAMME IN PARKINSON'S DISEASE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: therapeutic education
Parkinson's disease
quality of life
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2012-10-30
Enrollment: 120
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Quality of life with the PDQ39 scale
timeFrame: 1 year
Secondary outcomes:
measure: Quality of life with the SF36 scale
timeFrame: 1 year
measure: the motor state with UPDRS (Unified Pakinson's disease Rating Scale)
timeFrame: 1 year
measure: The psychological state with HAD (Hospital Anxiety and Depression) scale
timeFrame: 1 year
measure: Evaluation of social adaptation with SAS-SR (Social adjustement Scale Sel-Report) scale
timeFrame: 1 year
measure: Evaluation of medical costs
timeFrame: over the 12 months follow-up
Other outcomes:
Locations:
city: Toulouse
country: France
facility: UH Toulouse
Study officials:
References:
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.