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Education in Therapy of Parkinson's Disease (ETPARK)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01717144
First received: October 22, 2012
Last updated: October 29, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention
Parkinson Disease
 Behavioral: therapeutic education program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: EVALUATION OF A THERAPEUTIC EDUCATION PROGRAMME IN PARKINSON'S DISEASE

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • Quality of life with the PDQ39 scale [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quality of life with the SF36 scale [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • the motor state with UPDRS (Unified Pakinson's disease Rating Scale) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • The psychological state with HAD (Hospital Anxiety and Depression) scale [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Evaluation of social adaptation with SAS-SR (Social adjustement Scale Sel-Report) scale [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Evaluation of medical costs [ Time Frame: over the 12 months follow-up ] [ Designated as safety issue: Yes ]

Enrollment: 120
Study Start Date: December 2008
Study Completion Date: April 2011
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: traditional medical care
patients benefiting of a traditional medical care
Experimental: therapeutic education program
The educational program consisted of both individual and collective educational consultations with a therapeutic education nurse
 Behavioral: therapeutic education program
The educational program consisted of both individual and collective educational consultations with a therapeutic education nurse

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01717144

Locations
France
UH Toulouse
Toulouse, France, 31000
Sponsors and Collaborators
University Hospital, Toulouse
  More Information

No publications provided

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01717144     History of Changes
Other Study ID Numbers: 08 150 07
Study First Received: October 22, 2012
Last Updated: October 29, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Toulouse:
therapeutic education
Parkinson's disease
quality of life

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on May 19, 2013