<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01717144</url>
  </required_header>
  <id_info>
    <org_study_id>08 150 07</org_study_id>
    <nct_id>NCT01717144</nct_id>
  </id_info>
  <brief_title>Education in Therapy of Parkinson's Disease</brief_title>
  <acronym>ETPARK</acronym>
  <official_title>EVALUATION OF A THERAPEUTIC EDUCATION PROGRAMME IN PARKINSON'S DISEASE</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Toulouse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Toulouse</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Parkinson's disease (PD) has considerable impact on motor, psychological and social&#xD;
      activities and significantly affects the quality of life of patients and their families. To&#xD;
      improve the medical care of PD patients, the investigator have developed an educational&#xD;
      program specific to PD.&#xD;
&#xD;
      The principal aim of this study is to evaluate the therapeutic education Program, comparing&#xD;
      the quality of life of PD patients with or without the educational program after six month&#xD;
      and one year follow-up.&#xD;
&#xD;
      The secondary aims are to evaluate the evolution of motor and psychological states in these 2&#xD;
      groups of patients and to compare the medical costs.&#xD;
&#xD;
      This is a monocentric, comparative, prospective randomised study. The investigators will&#xD;
      evaluate 120 PD patients, 60 patients benefiting of the educational program and 60 patients&#xD;
      with a traditional medical care. Quality of life of PD patients is evaluated using a specific&#xD;
      scale (PDQ39) and a generalist scale (SF36) at 6 and 12 months. Motor and psychological&#xD;
      states were assessed with UPDRS and HAD Scales. The educational program consisted of both&#xD;
      individual and collective educational consultations.&#xD;
&#xD;
      The investigators supposed that the therapeutic education program will improve the quality of&#xD;
      life of PD patients. The supposition that this improvement will correlate with the motor and&#xD;
      psychological states.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2008</start_date>
  <completion_date type="Actual">April 2011</completion_date>
  <primary_completion_date type="Actual">December 2008</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of life with the PDQ39 scale</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life with the SF36 scale</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the motor state with UPDRS (Unified Pakinson's disease Rating Scale)</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The psychological state with HAD (Hospital Anxiety and Depression) scale</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of social adaptation with SAS-SR (Social adjustement Scale Sel-Report) scale</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of medical costs</measure>
    <time_frame>over the 12 months follow-up</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>traditional medical care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>patients benefiting of a traditional medical care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>therapeutic education program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The educational program consisted of both individual and collective educational consultations with a therapeutic education nurse</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>therapeutic education program</intervention_name>
    <description>The educational program consisted of both individual and collective educational consultations with a therapeutic education nurse</description>
    <arm_group_label>therapeutic education program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with clinical diagnosis of Parkinson's disease according to the criteria of&#xD;
             the UKPDSBB&#xD;
&#xD;
          -  Parkinson's disease patients with a score ≤4 on the Hoehn and Year scale&#xD;
&#xD;
          -  Patient without cognitive disorders&#xD;
&#xD;
          -  Patients treated with dopaminergic antiparkisonian drugs (L-DOPA, dopamine&#xD;
             agonists,ICOMT…) or DBS stimulation (since at least 3 month)&#xD;
&#xD;
          -  Patients able to fulfil self-administered questionnaire&#xD;
&#xD;
          -  Patients affiliated to a social protection program&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  - Patients suffering from an other pathology causing chronic pain (rheumatic disease,&#xD;
             traumatic or orthopaedic pathologies…)&#xD;
&#xD;
          -  Parkinson's disease patients with a score&gt;5 on the Hoehn and Yahr scale&#xD;
&#xD;
          -  Patients suffering of parkinsonism induce by drugs&#xD;
&#xD;
          -  Patients with important tremors during a OFF conditions&#xD;
&#xD;
          -  Patients ever included in another study&#xD;
&#xD;
          -  Patients with severe psychiatric disease&#xD;
&#xD;
          -  Patients under tutelage, curatelle or law protection&#xD;
&#xD;
          -  Patients included in an other clinical study&#xD;
&#xD;
          -  Patients unable to fulfil scales of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>UH Toulouse</name>
      <address>
        <city>Toulouse</city>
        <zip>31000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <results_reference>
    <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.</citation>
    <PMID>24267951</PMID>
  </results_reference>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>October 22, 2012</study_first_submitted>
  <study_first_submitted_qc>October 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>May 10, 2017</last_update_submitted>
  <last_update_submitted_qc>May 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>therapeutic education</keyword>
  <keyword>Parkinson's disease</keyword>
  <keyword>quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01717144
org study id: 08 150 07
nct id: NCT01717144
lead sponsor: 
has dmc: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Quality of life with the PDQ39 scale
time frame: 1 year
measure: Quality of life with the SF36 scale
time frame: 1 year
measure: the motor state with UPDRS (Unified Pakinson's disease Rating Scale)
time frame: 1 year
measure: The psychological state with HAD (Hospital Anxiety and Depression) scale
time frame: 1 year
measure: Evaluation of social adaptation with SAS-SR (Social adjustement Scale Sel-Report) scale
time frame: 1 year
measure: Evaluation of medical costs
time frame: over the 12 months follow-up
arm group label: traditional medical care
arm group type: No Intervention
description: patients benefiting of a traditional medical care
arm group label: therapeutic education program
arm group type: Experimental
description: The educational program consisted of both individual and collective educational consultations with a therapeutic education nurse
intervention type: Behavioral
intervention name: therapeutic education program
description: The educational program consisted of both individual and collective educational consultations with a therapeutic education nurse
arm group label: therapeutic education program
criteria: 
gender: All
minimum age: 30 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: France
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.
PMID: 24267951
responsible party type: Sponsor
mesh term: Parkinson Disease