Education in Therapy of Parkinson's Disease

NCT ID: NCT01717144

Last Updated: 2017-05-12

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2011-04-30

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.

Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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traditional medical care

patients benefiting of a traditional medical care

Group Type NO_INTERVENTION

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

Group Type EXPERIMENTAL

therapeutic education program

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UH Toulouse

Toulouse, , France

Site Status

Countries

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France

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.

Reference Type RESULT
PMID: 24267951 (View on PubMed)

Other Identifiers

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08 150 07

Identifier Type: -

Identifier Source: org_study_id

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