Education in Therapy of Parkinson's Disease (ETPARK)

May 10, 2017 updated by: University Hospital, Toulouse

EVALUATION OF A THERAPEUTIC EDUCATION PROGRAMME IN PARKINSON'S DISEASE

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France, 31000
        • Uh Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quality of life with the PDQ39 scale
Time Frame: 1 year
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

October 22, 2012

First Submitted That Met QC Criteria

October 29, 2012

First Posted (Estimate)

October 30, 2012

Study Record Updates

Last Update Posted (Actual)

May 12, 2017

Last Update Submitted That Met QC Criteria

May 10, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08 150 07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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