xml: <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/NCT06033326</url>
    </required_header>
    <id_info>
      <org_study_id>2020_98</org_study_id>
      <nct_id>NCT06033326</nct_id>
    </id_info>
    <brief_title>Validation of the French Version of the Lithium Knowledge Test (LKT)</brief_title>
    <acronym>LKT</acronym>
    <official_title>Validation of the French Version of the Lithium Knowledge Test (LKT) for Patients Treated With Lithium in Psychiatric Unit Hospitals</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Lille</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </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>
        Lithium is a drug used to treat several psychiatric illnesses. This medication requires&#xD;
        particular vigilance because it has a narrow therapeutic margin: the dose necessary to obtain&#xD;
        an effective treatment is close to the toxic dose.&#xD;
  &#xD;
        The blood dosage of the drug and the patient's knowledge of the drug are necessary to&#xD;
        optimize and secure the drug intake.&#xD;
  &#xD;
        The objective of this observational study is to confirm that the score obtained by the LKT&#xD;
        lithium knowledge self-questionnaire translated into French is representative of the&#xD;
        knowledge of patients treated with lithium.&#xD;
  &#xD;
        Participants will be asked to complete this questionnaire twice, and the scores obtained will&#xD;
        be compared to the blood lithium level to see if a good score is associated with an effective&#xD;
        blood lithium concentration.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 30, 2023</start_date>
    <completion_date type="Anticipated">October 10, 2025</completion_date>
    <primary_completion_date type="Anticipated">October 10, 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Assessment of the factorial validity of the score from the first completed LKT self-questionnaire</measure>
      <time_frame>2 yaers</time_frame>
      <description>Baseline: percentage of inertia explained by the first component of the principal component analysis Maximum time to obtain scores for 300 self-questionnaires: 2 years</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Evaluation of the internal consistency of the LKT score: is acceptable if Cronbach's alpha is greater than 0.7</measure>
      <time_frame>2 yaers</time_frame>
      <description>Baseline after data collection: percentage of inertia explained by the first component of the principal component analysis Maximum time to obtain scores for 300 self-questionnaires: 2 years</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>External validity of the LKT self-questionnaire by measuring the correlation between the lithiaemia assay at D0 and the score obtained on the self-questionnaire at D0.</measure>
      <time_frame>2 yaers</time_frame>
      <description>Baseline after data collection: percentage of inertia explained by the first component of the principal component analysis Maximum time to obtain scores for 300 self-questionnaires: 2 years</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of the test/retest reliability of the LKT self-questionnaire score measured at D0 and D4.</measure>
      <time_frame>2 years</time_frame>
      <description>Baseline and 4 days after data collection Maximum time to obtain scores for 300 self-questionnaires: 2 years</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Comparison of lithiaemia at D0 between patients with good knowledge (i.e. a LKT self-questionnaire score at D0 &gt; 6) and those with poor knowledge of treatment</measure>
      <time_frame>2 years</time_frame>
      <description>Baseline and 4 days after data collection Maximum time to obtain scores for 300 self-questionnaires: 2 years</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Search for factors associated with the LKT self-questionnaire score at J0.</measure>
      <time_frame>2 years</time_frame>
      <description>Baseline and 4 days after data collection Maximum time to obtain scores for 300 self-questionnaires: 2 years</description>
    </secondary_outcome>
    <enrollment type="Anticipated">300</enrollment>
    <condition>Patient Treated With Lithium, With Bipolar or Schizo-affective Disorder, Hospitalized in a Psychiatric Ward</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients hospitalized in an adult psychiatric ward or staying in an EPSM in the cities&#xD;
          included in this study&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient hospitalized in a psychiatric ward or in an EPSM for more than 10 consecutive&#xD;
               days&#xD;
  &#xD;
            -  Patient treated with IR or ER lithium LI&#xD;
  &#xD;
            -  Patient over 18 years of&#xD;
  &#xD;
            -  Patient on a fixed dosage of lithium for more than 5 days prior to blood sampling for&#xD;
               lithiaemia testing&#xD;
  &#xD;
            -  Obtain patient's non-opposition&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Clinically unstable patient or patient with a cognitive disorder that makes it&#xD;
               impossible to perform interview and/or completion of the LKT self-questionnaire&#xD;
  &#xD;
            -  Patients under guardianship or trusteeship&#xD;
  &#xD;
            -  Illiterate patients&#xD;
  &#xD;
            -  Patient with a therapeutic target concentration different from general recommendations&#xD;
               (e.g. elderly subject)&#xD;
  &#xD;
            -  Patient receiving a pharmaceutical interview or any other interview between the&#xD;
               completion of the 1 and 2nd questionnaires, likely to modify the LKT score.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Lithium</keyword>
    <keyword>observance</keyword>
    <keyword>security</keyword>
    <keyword>Lithium Knowledge Test</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Mood Disorders</mesh_term>
      <mesh_term>Psychotic Disorders</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06033326
  org study id: 2020_98
  nct id: NCT06033326
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Lithium is a drug used to treat several psychiatric illnesses. This medication requires
        particular vigilance because it has a narrow therapeutic margin: the dose necessary to obtain
        an effective treatment is close to the toxic dose.
  
        The blood dosage of the drug and the patient's knowledge of the drug are necessary to
        optimize and secure the drug intake.
  
        The objective of this observational study is to confirm that the score obtained by the LKT
        lithium knowledge self-questionnaire translated into French is representative of the
        knowledge of patients treated with lithium.
  
        Participants will be asked to complete this questionnaire twice, and the scores obtained will
        be compared to the blood lithium level to see if a good score is associated with an effective
        blood lithium concentration.
  observational model: Cohort
  time perspective: Prospective
  measure: Assessment of the factorial validity of the score from the first completed LKT self-questionnaire
  time frame: 2 yaers
  description: Baseline: percentage of inertia explained by the first component of the principal component analysis Maximum time to obtain scores for 300 self-questionnaires: 2 years
  measure: Evaluation of the internal consistency of the LKT score: is acceptable if Cronbach's alpha is greater than 0.7
  time frame: 2 yaers
  description: Baseline after data collection: percentage of inertia explained by the first component of the principal component analysis Maximum time to obtain scores for 300 self-questionnaires: 2 years
  measure: External validity of the LKT self-questionnaire by measuring the correlation between the lithiaemia assay at D0 and the score obtained on the self-questionnaire at D0.
  time frame: 2 yaers
  description: Baseline after data collection: percentage of inertia explained by the first component of the principal component analysis Maximum time to obtain scores for 300 self-questionnaires: 2 years
  measure: Evaluation of the test/retest reliability of the LKT self-questionnaire score measured at D0 and D4.
  time frame: 2 years
  description: Baseline and 4 days after data collection Maximum time to obtain scores for 300 self-questionnaires: 2 years
  measure: Comparison of lithiaemia at D0 between patients with good knowledge (i.e. a LKT self-questionnaire score at D0 > 6) and those with poor knowledge of treatment
  time frame: 2 years
  description: Baseline and 4 days after data collection Maximum time to obtain scores for 300 self-questionnaires: 2 years
  measure: Search for factors associated with the LKT self-questionnaire score at J0.
  time frame: 2 years
  description: Baseline and 4 days after data collection Maximum time to obtain scores for 300 self-questionnaires: 2 years
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Sponsor
  mesh term: Mood Disorders
  mesh term: Psychotic Disorders