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Education in Therapy of Parkinson's Disease (ETPARK)

T

Toulouse University Hospital

Status

Completed

Conditions

Parkinson Disease

Treatments

Behavioral: therapeutic education program

Study type

Interventional

Funder types

Other

Identifiers

NCT01717144
08 150 07

Details and patient eligibility

About

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.

Enrollment

120 patients

Sex

All

Ages

30 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 2 patient groups

traditional medical care
No Intervention group
Description:
patients benefiting of a traditional medical care
therapeutic education program
Experimental group
Description:
The educational program consisted of both individual and collective educational consultations with a therapeutic education nurse
Treatment:
Behavioral: therapeutic education program

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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