<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/NCT03255863</url>
  </required_header>
  <id_info>
    <org_study_id>2015_70</org_study_id>
    <secondary_id>2016-A02057-44</secondary_id>
    <nct_id>NCT03255863</nct_id>
  </id_info>
  <brief_title>Determinants of Patients' Uptake of Therapeutic Education Programme</brief_title>
  <acronym>UTEP</acronym>
  <official_title>Determinants of Patients' Uptake of Therapeutic Education Programme</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Lille</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Therapeutic Patient Education (TPE) refers to programs that help patients to manage life with&#xD;
      a chronic disease in the best possible way. In spite of the effectiveness of Therapeutic&#xD;
      Patient Education, few patients uptake TPE when it is proposed to them. Therefore, our main&#xD;
      aim was to identify patients' beliefs that will predict patients' uptake of TPE. According to&#xD;
      the Health Belief Model, patient will participate in TPE if they perceive their disease as a&#xD;
      serious threat (with possible serious complications), but which can be controlled however,&#xD;
      and that TPE is efficient and represents little burden.&#xD;
&#xD;
      Secondary aims are as follows:&#xD;
&#xD;
        1. To test whether the way TPE is presented to patients impact patients' decision to uptake&#xD;
           TPE. The way TPE is presented comprises the time between diagnosis and the proposal of&#xD;
           TPE, whether patient is a remission or crisis period in the disease, the time between&#xD;
           the proposal and the next TPE session, and what is said by healthcare professionals to&#xD;
           present TPE.&#xD;
&#xD;
        2. To test whether healthcare professionals' empathy impact patients' decision to&#xD;
           participate in TPE&#xD;
&#xD;
        3. To test whether patients' intention to participate in TPE will predict their actual&#xD;
           participation.&#xD;
&#xD;
      The ultimate goal of the study is to identify patients whose beliefs will not favor&#xD;
      participation in TPE in order to accompany those patients more carefully. Best practices will&#xD;
      be proposed according the results.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 20, 2017</start_date>
  <completion_date type="Actual">September 9, 2020</completion_date>
  <primary_completion_date type="Actual">September 9, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient's intention to participated in TPE by a questionnaire based on the Health Belief Model</measure>
    <time_frame>Baseline (after TPE proposal)</time_frame>
    <description>Patient's participation in TPE : yes or no Participation is defined as the patient's intention to come expressly to the hospital for a first appointment dedicated to therapeutic education.&#xD;
The main variables of the HBM will be analyzed: perceived threat of the pathology, perceived benefits and barriers to TPE, perceived patient control of its pathology.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time limit of first proposition in TPE</measure>
    <time_frame>Baseline</time_frame>
    <description>Time between date of diagnostic illness and date of first first proposition in TPE</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Timeout of first participation in TPE</measure>
    <time_frame>Baseline</time_frame>
    <description>Time between date of proposition and date of the program begin of TPE</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical context in which TPE is proposed</measure>
    <time_frame>Baseline</time_frame>
    <description>Medical context in acute phase versus phase of stabilization of the pathology</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Consultation And Relational Empathy (CARE) questionnaire</measure>
    <time_frame>Baseline</time_frame>
    <description>The patient's perceived empathy of the professional (s) who offered the TPE will be assessed by the CARE questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual analog scale for intention to participated</measure>
    <time_frame>Baseline</time_frame>
    <description>Visual analog scale ranging from 0 &quot;not at all intending to participate&quot; to 100 &quot;very strong intention to participate Measurement of the patient's intention to participate in the proposed TPE program</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">459</enrollment>
  <condition>Chronic Disease</condition>
  <condition>Patient Education as Topic</condition>
  <condition>Patient Adherence</condition>
  <condition>Empathy</condition>
  <condition>Quality of Healthcare</condition>
  <arm_group>
    <arm_group_label>Questionnaire</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Auto and hetero questionnaire</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire</intervention_name>
    <description>Patient Self reported questionnaire filled in.</description>
    <arm_group_label>Questionnaire</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients to whom TPE was proposed in diabetes, hemophilia, obesity, cardiac failure,&#xD;
             chronic inflammatory bowel disease, parkinson, rare diseases, epilepsy, peripheral&#xD;
             arterial diseases&#xD;
&#xD;
          -  Belong to a social security scheme&#xD;
&#xD;
          -  Pregnant women to whom TPE for gestational diabetes is proposed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cognitive impairment declared by healthcare professionals&#xD;
&#xD;
          -  Inpatients&#xD;
&#xD;
          -  Patients for whom TPE is coupled with rehabilitation&#xD;
&#xD;
          -  Psychiatric disorders&#xD;
&#xD;
          -  Patients who cannot give informed consent&#xD;
&#xD;
          -  Patients in jail&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maryline Bourgoin</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Lille</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Claude Huriez, CHU</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>October 14, 2022</last_update_submitted>
  <last_update_submitted_qc>October 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 17, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Psychological Theory</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03255863
org study id: 2015_70
secondary id: 2016-A02057-44
nct id: NCT03255863
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Therapeutic Patient Education (TPE) refers to programs that help patients to manage life with
      a chronic disease in the best possible way. In spite of the effectiveness of Therapeutic
      Patient Education, few patients uptake TPE when it is proposed to them. Therefore, our main
      aim was to identify patients' beliefs that will predict patients' uptake of TPE. According to
      the Health Belief Model, patient will participate in TPE if they perceive their disease as a
      serious threat (with possible serious complications), but which can be controlled however,
      and that TPE is efficient and represents little burden.

      Secondary aims are as follows:

        1. To test whether the way TPE is presented to patients impact patients' decision to uptake
           TPE. The way TPE is presented comprises the time between diagnosis and the proposal of
           TPE, whether patient is a remission or crisis period in the disease, the time between
           the proposal and the next TPE session, and what is said by healthcare professionals to
           present TPE.

        2. To test whether healthcare professionals' empathy impact patients' decision to
           participate in TPE

        3. To test whether patients' intention to participate in TPE will predict their actual
           participation.

      The ultimate goal of the study is to identify patients whose beliefs will not favor
      participation in TPE in order to accompany those patients more carefully. Best practices will
      be proposed according the results.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Patient's intention to participated in TPE by a questionnaire based on the Health Belief Model
time frame: Baseline (after TPE proposal)
description: Patient's participation in TPE : yes or no Participation is defined as the patient's intention to come expressly to the hospital for a first appointment dedicated to therapeutic education.
The main variables of the HBM will be analyzed: perceived threat of the pathology, perceived benefits and barriers to TPE, perceived patient control of its pathology.
measure: Time limit of first proposition in TPE
time frame: Baseline
description: Time between date of diagnostic illness and date of first first proposition in TPE
measure: Timeout of first participation in TPE
time frame: Baseline
description: Time between date of proposition and date of the program begin of TPE
measure: Medical context in which TPE is proposed
time frame: Baseline
description: Medical context in acute phase versus phase of stabilization of the pathology
measure: Consultation And Relational Empathy (CARE) questionnaire
time frame: Baseline
description: The patient's perceived empathy of the professional (s) who offered the TPE will be assessed by the CARE questionnaire
measure: Visual analog scale for intention to participated
time frame: Baseline
description: Visual analog scale ranging from 0 "not at all intending to participate" to 100 "very strong intention to participate Measurement of the patient's intention to participate in the proposed TPE program
arm group label: Questionnaire
arm group type: Other
description: Auto and hetero questionnaire
intervention type: Other
intervention name: Questionnaire
description: Patient Self reported questionnaire filled in.
arm group label: Questionnaire
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Maryline Bourgoin
role: Principal Investigator
affiliation: University Hospital, Lille
facility: 
country: France
responsible party type: Sponsor
mesh term: Chronic Disease
sharing ipd: No