<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/NCT03245593</url>
  </required_header>
  <id_info>
    <org_study_id>PREPS/2016/LS-01</org_study_id>
    <nct_id>NCT03245593</nct_id>
  </id_info>
  <brief_title>Shared Medical Decision Making in the Prophylactic Treatment of Bipolar Disorder</brief_title>
  <acronym>ShareD-BD</acronym>
  <official_title>Shared Medical Decision Making in the Prophylactic Treatment of Bipolar Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Nīmes</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Nīmes</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators hypothesize that implementation of a shared decision making care plan for&#xD;
      prophylactic treatment will help therapeutic adherence of bipolar patients. They also&#xD;
      anticipate that patients treated according to a shared decision making plan will have an&#xD;
      elevated satisfaction of their care, quality of life and functionment, as well as a lower&#xD;
      number of relapses&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 24, 2018</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Measure the difference of prophylactic treatment compliance between bipolar patients receiving treatment according to standard care versus a shared decision making care plan following a mood episode.</measure>
    <time_frame>12 months</time_frame>
    <description>Clinician Rating Scale (1-7)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Study the clinician-reported difference between the 2 groups in medication adherence</measure>
    <time_frame>3 months</time_frame>
    <description>Clinician Rating Scale (1-7)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Study the clinician-reported difference between the 2 groups in medication adherence</measure>
    <time_frame>6 months</time_frame>
    <description>Clinician Rating Scale (1-7)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Study the clinician-reported difference between the 2 groups in medication adherence</measure>
    <time_frame>9 months</time_frame>
    <description>Clinician Rating Scale (1-7)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Study the self-reported difference between the 2 groups in medication adherence</measure>
    <time_frame>3 months</time_frame>
    <description>Medication Adherence Rating Scale( 0-10),</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Study the self-reported difference between the 2 groups in medication adherence</measure>
    <time_frame>6 months</time_frame>
    <description>Medication Adherence Rating Scale( 0-10),</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Study the self-reported difference between the 2 groups in medication adherence</measure>
    <time_frame>9 months</time_frame>
    <description>Medication Adherence Rating Scale( 0-10),</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Study the self-reported difference between the 2 groups in medication adherence</measure>
    <time_frame>12 months</time_frame>
    <description>Medication Adherence Rating Scale( 0-10),</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical evaluation of the difference between the 2 groups in medication adherence</measure>
    <time_frame>3 months</time_frame>
    <description>Plasma levels of medication for treatment of bipolar disorder, Lithium, anticonvulsants, second generation antipsychotics and antidepressants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical evaluation of the difference between the 2 groups in medication adherence</measure>
    <time_frame>6 months</time_frame>
    <description>Plasma levels of medication for treatment of bipolar disorder, Lithium, anticonvulsants, second generation antipsychotics and antidepressants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical evaluation of the difference between the 2 groups in medication adherence</measure>
    <time_frame>9 months</time_frame>
    <description>Plasma levels of medication for treatment of bipolar disorder, Lithium, anticonvulsants, second generation antipsychotics and antidepressants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical evaluation of the difference between the 2 groups in medication adherence</measure>
    <time_frame>12 months</time_frame>
    <description>Plasma levels of medication for treatment of bipolar disorder, Lithium, anticonvulsants, second generation antipsychotics and antidepressants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare difference in the adherence to personalized follow-up between groups</measure>
    <time_frame>3 months</time_frame>
    <description>percentage of consultations missed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare difference in the adherence to personalized follow-up between groups</measure>
    <time_frame>6 months</time_frame>
    <description>percentage of consultations missed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare difference in the adherence to personalized follow-up between groups</measure>
    <time_frame>9 months</time_frame>
    <description>percentage of consultations missed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare difference in the adherence to personalized follow-up between groups</measure>
    <time_frame>12 months</time_frame>
    <description>percentage of consultations missed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare difference in patient perceptions related to the uncertainty of the medical decisions taken between groups</measure>
    <time_frame>3 months</time_frame>
    <description>decisional conflict scale (0-100)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare difference in patient perceptions related to the uncertainty of the medical decisions taken between groups</measure>
    <time_frame>6 months</time_frame>
    <description>decisional conflict scale (0-100)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare difference in patient perceptions related to the uncertainty of the medical decisions taken between groups</measure>
    <time_frame>9 months</time_frame>
    <description>decisional conflict scale (0-100)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare difference in patient perceptions related to the uncertainty of the medical decisions taken between groups</measure>
    <time_frame>12 months</time_frame>
    <description>decisional conflict scale (0-100)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare difference in patient satisfaction concerning the therapeutic decisions taken between groups</measure>
    <time_frame>3 months</time_frame>
    <description>adapted QSH-45: 3 questions scored 1-5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare difference in patient satisfaction concerning the therapeutic decisions taken between groups</measure>
    <time_frame>6 months</time_frame>
    <description>adapted QSH-45: 3 questions scored 1-5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare difference in patient satisfaction concerning the therapeutic decisions taken between groups</measure>
    <time_frame>9 months</time_frame>
    <description>adapted QSH-45: 3 questions scored 1-5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare difference in patient satisfaction concerning the therapeutic decisions taken between groups</measure>
    <time_frame>12 months</time_frame>
    <description>adapted QSH-45: 3 questions scored 1-5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare difference in patient satisfaction concerning the decision-making process between groups</measure>
    <time_frame>3 months</time_frame>
    <description>Adapted clinical decision making involvement and satisfaction score 3 questions scored 1-5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare difference in patient satisfaction concerning the decision-making process between groups</measure>
    <time_frame>6 months</time_frame>
    <description>Adapted clinical decision making involvement and satisfaction score 3 questions scored 1-5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare difference in patient satisfaction concerning the decision-making process between groups</measure>
    <time_frame>9 months</time_frame>
    <description>Adapted clinical decision making involvement and satisfaction score 3 questions scored 1-5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare difference in patient satisfaction concerning the decision-making process between groups</measure>
    <time_frame>12 months</time_frame>
    <description>Adapted clinical decision making involvement and satisfaction score 3 questions scored 1-5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare difference in therapeutic alliance between groups</measure>
    <time_frame>3 months</time_frame>
    <description>4-Point ordinal Alliance Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare difference in therapeutic alliance between groups</measure>
    <time_frame>6 months</time_frame>
    <description>4-Point ordinal Alliance Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare difference in therapeutic alliance between groups</measure>
    <time_frame>9 months</time_frame>
    <description>4-Point ordinal Alliance Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare difference in therapeutic alliance between groups</measure>
    <time_frame>12 months</time_frame>
    <description>4-Point ordinal Alliance Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare difference in knowledge of disease and treatment necessary to making decisions between groups</measure>
    <time_frame>3 months</time_frame>
    <description>Knowledge questionnaire: % correct answers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare difference in knowledge of disease and treatment necessary to making decisions between groups</measure>
    <time_frame>6 months</time_frame>
    <description>Knowledge questionnaire: % correct answers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare difference in knowledge of disease and treatment necessary to making decisions between groups</measure>
    <time_frame>9 months</time_frame>
    <description>Knowledge questionnaire: % correct answers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare difference in knowledge of disease and treatment necessary to making decisions between groups</measure>
    <time_frame>12 months</time_frame>
    <description>Knowledge questionnaire: % correct answers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare difference in patient attitude towards the treatment between groups</measure>
    <time_frame>3 months</time_frame>
    <description>Beliefs about Medicines Questionnaire: 18 questions 1-5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare difference in patient attitude towards the treatment between groups</measure>
    <time_frame>6 months</time_frame>
    <description>Beliefs about Medicines Questionnaire: 18 questions 1-5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare difference in patient attitude towards the treatment between groups</measure>
    <time_frame>9 months</time_frame>
    <description>Beliefs about Medicines Questionnaire: 18 questions 1-5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare difference in patient attitude towards the treatment between groups</measure>
    <time_frame>12 months</time_frame>
    <description>Beliefs about Medicines Questionnaire: 18 questions 1-5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare number and duration of mood episodes between groups months</measure>
    <time_frame>3 months</time_frame>
    <description>number of events; number of days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare number and duration of mood episodes between groups months</measure>
    <time_frame>6 months</time_frame>
    <description>number of events; number of days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare number and duration of mood episodes between groups months</measure>
    <time_frame>9 months</time_frame>
    <description>number of events; number of days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare number and duration of mood episodes between groups months</measure>
    <time_frame>12 months</time_frame>
    <description>number of events; number of days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare number and duration of hospitalizations in psychiatric service between groups</measure>
    <time_frame>3 months</time_frame>
    <description>number of events; number of days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare number and duration of hospitalizations in psychiatric service between groups</measure>
    <time_frame>6 months</time_frame>
    <description>number of events; number of days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare number and duration of hospitalizations in psychiatric service between groups</measure>
    <time_frame>9 months</time_frame>
    <description>number of events; number of days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare number and duration of hospitalizations in psychiatric service between groups</measure>
    <time_frame>12 months</time_frame>
    <description>number of events; number of days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare manic symptomatology during evaluations between groups</measure>
    <time_frame>3 months</time_frame>
    <description>Young Mania Rating Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare manic symptomatology during evaluations between groups</measure>
    <time_frame>6 months</time_frame>
    <description>Young Mania Rating Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare manic symptomatology during evaluations between groups</measure>
    <time_frame>9 months</time_frame>
    <description>Young Mania Rating Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare manic symptomatology during evaluations between groups</measure>
    <time_frame>12 months</time_frame>
    <description>Young Mania Rating Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare the depressive symptomatology during evaluations between groups</measure>
    <time_frame>3 months</time_frame>
    <description>Montgomery-Asberg Depression Rating Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare the depressive symptomatology during evaluations between groups</measure>
    <time_frame>6 months</time_frame>
    <description>Montgomery-Asberg Depression Rating Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare the depressive symptomatology during evaluations between groups</measure>
    <time_frame>9 months</time_frame>
    <description>Montgomery-Asberg Depression Rating Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare the depressive symptomatology during evaluations between groups</measure>
    <time_frame>12 months</time_frame>
    <description>Montgomery-Asberg Depression Rating Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare severity and intensity of suicidal ideas between groups</measure>
    <time_frame>3 months</time_frame>
    <description>Columbia-Suicide Severity Rating Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare severity and intensity of suicidal ideas between groups</measure>
    <time_frame>6 months</time_frame>
    <description>Columbia-Suicide Severity Rating Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare severity and intensity of suicidal ideas between groups</measure>
    <time_frame>9 months</time_frame>
    <description>Columbia-Suicide Severity Rating Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare severity and intensity of suicidal ideas between groups</measure>
    <time_frame>12 months</time_frame>
    <description>Columbia-Suicide Severity Rating Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare the psychosocial functioning between groups</measure>
    <time_frame>3 months</time_frame>
    <description>Functioning Assessment Short Test (0-72)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare the psychosocial functioning between groups</measure>
    <time_frame>6 months</time_frame>
    <description>Functioning Assessment Short Test (0-72)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare the psychosocial functioning between groups</measure>
    <time_frame>9 months</time_frame>
    <description>Functioning Assessment Short Test (0-72)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare the psychosocial functioning between groups</measure>
    <time_frame>12 months</time_frame>
    <description>Functioning Assessment Short Test (0-72)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare quality of life between groups</measure>
    <time_frame>3 months</time_frame>
    <description>WHOQOL-BREF (0-100)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare quality of life between groups</measure>
    <time_frame>6 months</time_frame>
    <description>WHOQOL-BREF (0-100)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare quality of life between groups</measure>
    <time_frame>9 months</time_frame>
    <description>WHOQOL-BREF (0-100)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare quality of life between groups</measure>
    <time_frame>12 months</time_frame>
    <description>WHOQOL-BREF (0-100)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare length of consultations between groups</measure>
    <time_frame>every consultation for 12 months</time_frame>
    <description>minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinician satisfaction concerning the therapeutic decisions taken between groups</measure>
    <time_frame>3 months</time_frame>
    <description>adapted QSH-45 doctor version 3 questions scored 1-5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinician satisfaction concerning the therapeutic decisions taken between groups</measure>
    <time_frame>6 months</time_frame>
    <description>adapted QSH-45 doctor version 3 questions scored 1-5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinician satisfaction concerning the therapeutic decisions taken between groups</measure>
    <time_frame>9 months</time_frame>
    <description>adapted QSH-45 doctor version 3 questions scored 1-5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinician satisfaction concerning the therapeutic decisions taken between groups</measure>
    <time_frame>12 months</time_frame>
    <description>adapted QSH-45 doctor version 3 questions scored 1-5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinician satisfaction concerning the decision-making process between groups</measure>
    <time_frame>3 months</time_frame>
    <description>Adapted clinical decision making involvement and satisfaction score doctor version 3: questions scored 1-5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinician satisfaction concerning the decision-making process between groups</measure>
    <time_frame>6 months</time_frame>
    <description>Adapted clinical decision making involvement and satisfaction score doctor version 3: questions scored 1-5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinician satisfaction concerning the decision-making process between groups</measure>
    <time_frame>9 months</time_frame>
    <description>Adapted clinical decision making involvement and satisfaction score doctor version 3: questions scored 1-5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinician satisfaction concerning the decision-making process between groups</measure>
    <time_frame>12 months</time_frame>
    <description>Adapted clinical decision making involvement and satisfaction score doctor version 3: questions scored 1-5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinician perceptions related to the uncertainty of the medical decisions taken between groups</measure>
    <time_frame>3 months</time_frame>
    <description>decisional conflict scale doctor version (0-100)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinician perceptions related to the uncertainty of the medical decisions taken between groups</measure>
    <time_frame>6 months</time_frame>
    <description>decisional conflict scale doctor version (0-100)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinician perceptions related to the uncertainty of the medical decisions taken between groups</measure>
    <time_frame>9 months</time_frame>
    <description>decisional conflict scale doctor version (0-100)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinician perceptions related to the uncertainty of the medical decisions taken between groups</measure>
    <time_frame>12 months</time_frame>
    <description>decisional conflict scale doctor version (0-100)</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Bipolar Disorder</condition>
  <arm_group>
    <arm_group_label>Shared Decision making for care</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard decision making for care</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Shared-decision making process</intervention_name>
    <description>Completion of the Ottawa Personal Decision Guide to help guide care with the support of online and printed material describing the therapeutic options available</description>
    <arm_group_label>Shared Decision making for care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>standard care</intervention_name>
    <description>Care of patients according to standard practice of managing patients with bipolar disorder</description>
    <arm_group_label>Standard decision making for care</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with biopolar disorder in consultation at one of the recruiting centers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patient must have given their free and informed consent and signed the consent&#xD;
             form&#xD;
&#xD;
          -  The patient must be a member or beneficiary of a health insurance plan&#xD;
&#xD;
          -  The patient must be available for the 12 months of follow-up&#xD;
&#xD;
          -  The patient is at least 18 years old&#xD;
&#xD;
          -  Patients is suffering from bipolar disorder (I or II) according to DSM-5 criteria&#xD;
&#xD;
          -  Following resolution of a mood episode (manic or depressive according to DSM-5&#xD;
             criteria) according to the criteria of l'International Society for Bipolar Disorder&#xD;
             (Recovery, clinical remission of at least 4 weeks)&#xD;
&#xD;
          -  Followed by at least one of the practitioner belonging to one of the participating&#xD;
             centers&#xD;
&#xD;
          -  Without comprehension problems of fluent French&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The subject is participating in an interventional study, or has participated in&#xD;
             another interventional study within the previous 3 months&#xD;
&#xD;
          -  The subject is in a period of exclusion determined by a previous study&#xD;
&#xD;
          -  The patient is under safeguard of justice or state guardianship&#xD;
&#xD;
          -  It is impossible to give the subject informed information, or the subject refuses to&#xD;
             sign the consent&#xD;
&#xD;
          -  The subject has already participated in this study&#xD;
&#xD;
          -  The patient has troubles linked to the usage of severe intensive substances (such as&#xD;
             those defined by the DMS-5)&#xD;
&#xD;
          -  The patient has a revision of the initial diagnosis of bipolar disorder&#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>Ludovic Samalin</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Clermont-Ferrand</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ludovic Samalin, MD</last_name>
    <phone>+33 (0)4 73 752 125</phone>
    <email>lsamalin@chu-clermontferrand.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ch Beziers</name>
      <address>
        <city>Beziers</city>
        <zip>34500</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>BELZEAUX RAOUL</last_name>
      <email>belzeaux.raoul@gmail.com</email>
    </contact>
    <investigator>
      <last_name>HAOUI RADOINE</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CH Charles Perrens</name>
      <address>
        <city>Bordeaux</city>
        <zip>33076</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Sebastien Gard</last_name>
      <email>sgard@ch-perrens.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CH le Vinatier</name>
      <address>
        <city>Bron</city>
        <zip>69678</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thierry D'Amato</last_name>
      <email>thierry.damato@ch-le-vinatier.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Chu Gabriel Montpied Clermont Ferrand</name>
      <address>
        <city>Clermont Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>BOURLOT FABIEN</last_name>
      <phone>04.73.75.21.25</phone>
      <email>fbourlot@clermontferrand.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Clermont Ferrand - Hôpital Gabriel-Montpied</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ludovic Samalin</last_name>
      <email>lsamalin@chu-clermontferrand.fr</email>
    </contact>
    <investigator>
      <last_name>Pierre-Michel Llorca</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ludovic Samalin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CH Sainte-Marie de Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63037</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jean-Alexandre Lesturgeon</last_name>
      <email>jean-alexandre.lesturgeon@clermont-groupe-sainte-marie.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>APHP - Centre Hospitalier Henri Mondor</name>
      <address>
        <city>Créteil</city>
        <zip>94010</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marion Leboyer</last_name>
      <email>marion.leboyer@inserm.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Grenoble - Hôpital Albert Michallon</name>
      <address>
        <city>Grenoble</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mircea Polosan</last_name>
      <email>mpolosan@chu-grenoble.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CH Limoges</name>
      <address>
        <city>Limoges</city>
        <zip>87025</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Eric CHARLES, ph</last_name>
      <phone>+33 555431010</phone>
      <email>echarles87@orange.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>APHM - Hôpital Sainte-Marguerite</name>
      <address>
        <city>Marseille</city>
        <zip>13274</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jean-Michel Azorin</last_name>
      <email>jazorin@ap-hm.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Montpellier - Hôpital Lapeyronie</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Philippe Courtet</last_name>
      <email>p-courtet@chu-montpellier.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU Nancy</name>
      <address>
        <city>Nancy</city>
        <zip>54000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Thomas Schwitzer, puph</last_name>
      <phone>+33 383852415</phone>
      <email>thomas.schwitzer@univ-lorraine.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU Nantes</name>
      <address>
        <city>Nantes</city>
        <zip>44000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Anne Sauvaget, puph</last_name>
      <phone>+33 240084795</phone>
      <email>anne.sauvaget@chu-nantes.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinique des troubles thymiques</name>
      <address>
        <city>Nîmes</city>
        <zip>30000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Justine Montjaux, Phd</last_name>
      <phone>+33 466683426</phone>
      <email>justine.montjaux@chu-nimes.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU Nimes</name>
      <address>
        <city>Nîmes</city>
        <zip>30029</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anissa Megzari</last_name>
      <phone>04.66.68.42.36</phone>
      <email>drc@chu-nimes.fr</email>
    </contact>
    <investigator>
      <last_name>Mocrane Abbar</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>APHP - Hôpital Saint Louis-Lariboisière-Fernand-Widal</name>
      <address>
        <city>Paris</city>
        <zip>75475</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Frank Bellivier</last_name>
      <email>frank.bellivier@inserm.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>September 7, 2023</last_update_submitted>
  <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bipolar Disorder</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/NCT03245593
org study id: PREPS/2016/LS-01
nct id: NCT03245593
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The investigators hypothesize that implementation of a shared decision making care plan for
      prophylactic treatment will help therapeutic adherence of bipolar patients. They also
      anticipate that patients treated according to a shared decision making plan will have an
      elevated satisfaction of their care, quality of life and functionment, as well as a lower
      number of relapses
observational model: Case-Only
time perspective: Prospective
measure: Measure the difference of prophylactic treatment compliance between bipolar patients receiving treatment according to standard care versus a shared decision making care plan following a mood episode.
time frame: 12 months
description: Clinician Rating Scale (1-7)
measure: Study the clinician-reported difference between the 2 groups in medication adherence
time frame: 3 months
description: Clinician Rating Scale (1-7)
measure: Study the clinician-reported difference between the 2 groups in medication adherence
time frame: 6 months
description: Clinician Rating Scale (1-7)
measure: Study the clinician-reported difference between the 2 groups in medication adherence
time frame: 9 months
description: Clinician Rating Scale (1-7)
measure: Study the self-reported difference between the 2 groups in medication adherence
time frame: 3 months
description: Medication Adherence Rating Scale( 0-10),
measure: Study the self-reported difference between the 2 groups in medication adherence
time frame: 6 months
description: Medication Adherence Rating Scale( 0-10),
measure: Study the self-reported difference between the 2 groups in medication adherence
time frame: 9 months
description: Medication Adherence Rating Scale( 0-10),
measure: Study the self-reported difference between the 2 groups in medication adherence
time frame: 12 months
description: Medication Adherence Rating Scale( 0-10),
measure: Clinical evaluation of the difference between the 2 groups in medication adherence
time frame: 3 months
description: Plasma levels of medication for treatment of bipolar disorder, Lithium, anticonvulsants, second generation antipsychotics and antidepressants
measure: Clinical evaluation of the difference between the 2 groups in medication adherence
time frame: 6 months
description: Plasma levels of medication for treatment of bipolar disorder, Lithium, anticonvulsants, second generation antipsychotics and antidepressants
measure: Clinical evaluation of the difference between the 2 groups in medication adherence
time frame: 9 months
description: Plasma levels of medication for treatment of bipolar disorder, Lithium, anticonvulsants, second generation antipsychotics and antidepressants
measure: Clinical evaluation of the difference between the 2 groups in medication adherence
time frame: 12 months
description: Plasma levels of medication for treatment of bipolar disorder, Lithium, anticonvulsants, second generation antipsychotics and antidepressants
measure: Compare difference in the adherence to personalized follow-up between groups
time frame: 3 months
description: percentage of consultations missed
measure: Compare difference in the adherence to personalized follow-up between groups
time frame: 6 months
description: percentage of consultations missed
measure: Compare difference in the adherence to personalized follow-up between groups
time frame: 9 months
description: percentage of consultations missed
measure: Compare difference in the adherence to personalized follow-up between groups
time frame: 12 months
description: percentage of consultations missed
measure: Compare difference in patient perceptions related to the uncertainty of the medical decisions taken between groups
time frame: 3 months
description: decisional conflict scale (0-100)
measure: Compare difference in patient perceptions related to the uncertainty of the medical decisions taken between groups
time frame: 6 months
description: decisional conflict scale (0-100)
measure: Compare difference in patient perceptions related to the uncertainty of the medical decisions taken between groups
time frame: 9 months
description: decisional conflict scale (0-100)
measure: Compare difference in patient perceptions related to the uncertainty of the medical decisions taken between groups
time frame: 12 months
description: decisional conflict scale (0-100)
measure: Compare difference in patient satisfaction concerning the therapeutic decisions taken between groups
time frame: 3 months
description: adapted QSH-45: 3 questions scored 1-5
measure: Compare difference in patient satisfaction concerning the therapeutic decisions taken between groups
time frame: 6 months
description: adapted QSH-45: 3 questions scored 1-5
measure: Compare difference in patient satisfaction concerning the therapeutic decisions taken between groups
time frame: 9 months
description: adapted QSH-45: 3 questions scored 1-5
measure: Compare difference in patient satisfaction concerning the therapeutic decisions taken between groups
time frame: 12 months
description: adapted QSH-45: 3 questions scored 1-5
measure: Compare difference in patient satisfaction concerning the decision-making process between groups
time frame: 3 months
description: Adapted clinical decision making involvement and satisfaction score 3 questions scored 1-5
measure: Compare difference in patient satisfaction concerning the decision-making process between groups
time frame: 6 months
description: Adapted clinical decision making involvement and satisfaction score 3 questions scored 1-5
measure: Compare difference in patient satisfaction concerning the decision-making process between groups
time frame: 9 months
description: Adapted clinical decision making involvement and satisfaction score 3 questions scored 1-5
measure: Compare difference in patient satisfaction concerning the decision-making process between groups
time frame: 12 months
description: Adapted clinical decision making involvement and satisfaction score 3 questions scored 1-5
measure: Compare difference in therapeutic alliance between groups
time frame: 3 months
description: 4-Point ordinal Alliance Scale
measure: Compare difference in therapeutic alliance between groups
time frame: 6 months
description: 4-Point ordinal Alliance Scale
measure: Compare difference in therapeutic alliance between groups
time frame: 9 months
description: 4-Point ordinal Alliance Scale
measure: Compare difference in therapeutic alliance between groups
time frame: 12 months
description: 4-Point ordinal Alliance Scale
measure: Compare difference in knowledge of disease and treatment necessary to making decisions between groups
time frame: 3 months
description: Knowledge questionnaire: % correct answers
measure: Compare difference in knowledge of disease and treatment necessary to making decisions between groups
time frame: 6 months
description: Knowledge questionnaire: % correct answers
measure: Compare difference in knowledge of disease and treatment necessary to making decisions between groups
time frame: 9 months
description: Knowledge questionnaire: % correct answers
measure: Compare difference in knowledge of disease and treatment necessary to making decisions between groups
time frame: 12 months
description: Knowledge questionnaire: % correct answers
measure: Compare difference in patient attitude towards the treatment between groups
time frame: 3 months
description: Beliefs about Medicines Questionnaire: 18 questions 1-5
measure: Compare difference in patient attitude towards the treatment between groups
time frame: 6 months
description: Beliefs about Medicines Questionnaire: 18 questions 1-5
measure: Compare difference in patient attitude towards the treatment between groups
time frame: 9 months
description: Beliefs about Medicines Questionnaire: 18 questions 1-5
measure: Compare difference in patient attitude towards the treatment between groups
time frame: 12 months
description: Beliefs about Medicines Questionnaire: 18 questions 1-5
measure: Compare number and duration of mood episodes between groups months
time frame: 3 months
description: number of events; number of days
measure: Compare number and duration of mood episodes between groups months
time frame: 6 months
description: number of events; number of days
measure: Compare number and duration of mood episodes between groups months
time frame: 9 months
description: number of events; number of days
measure: Compare number and duration of mood episodes between groups months
time frame: 12 months
description: number of events; number of days
measure: Compare number and duration of hospitalizations in psychiatric service between groups
time frame: 3 months
description: number of events; number of days
measure: Compare number and duration of hospitalizations in psychiatric service between groups
time frame: 6 months
description: number of events; number of days
measure: Compare number and duration of hospitalizations in psychiatric service between groups
time frame: 9 months
description: number of events; number of days
measure: Compare number and duration of hospitalizations in psychiatric service between groups
time frame: 12 months
description: number of events; number of days
measure: Compare manic symptomatology during evaluations between groups
time frame: 3 months
description: Young Mania Rating Scale
measure: Compare manic symptomatology during evaluations between groups
time frame: 6 months
description: Young Mania Rating Scale
measure: Compare manic symptomatology during evaluations between groups
time frame: 9 months
description: Young Mania Rating Scale
measure: Compare manic symptomatology during evaluations between groups
time frame: 12 months
description: Young Mania Rating Scale
measure: Compare the depressive symptomatology during evaluations between groups
time frame: 3 months
description: Montgomery-Asberg Depression Rating Scale
measure: Compare the depressive symptomatology during evaluations between groups
time frame: 6 months
description: Montgomery-Asberg Depression Rating Scale
measure: Compare the depressive symptomatology during evaluations between groups
time frame: 9 months
description: Montgomery-Asberg Depression Rating Scale
measure: Compare the depressive symptomatology during evaluations between groups
time frame: 12 months
description: Montgomery-Asberg Depression Rating Scale
measure: Compare severity and intensity of suicidal ideas between groups
time frame: 3 months
description: Columbia-Suicide Severity Rating Scale
measure: Compare severity and intensity of suicidal ideas between groups
time frame: 6 months
description: Columbia-Suicide Severity Rating Scale
measure: Compare severity and intensity of suicidal ideas between groups
time frame: 9 months
description: Columbia-Suicide Severity Rating Scale
measure: Compare severity and intensity of suicidal ideas between groups
time frame: 12 months
description: Columbia-Suicide Severity Rating Scale
measure: Compare the psychosocial functioning between groups
time frame: 3 months
description: Functioning Assessment Short Test (0-72)
measure: Compare the psychosocial functioning between groups
time frame: 6 months
description: Functioning Assessment Short Test (0-72)
measure: Compare the psychosocial functioning between groups
time frame: 9 months
description: Functioning Assessment Short Test (0-72)
measure: Compare the psychosocial functioning between groups
time frame: 12 months
description: Functioning Assessment Short Test (0-72)
measure: Compare quality of life between groups
time frame: 3 months
description: WHOQOL-BREF (0-100)
measure: Compare quality of life between groups
time frame: 6 months
description: WHOQOL-BREF (0-100)
measure: Compare quality of life between groups
time frame: 9 months
description: WHOQOL-BREF (0-100)
measure: Compare quality of life between groups
time frame: 12 months
description: WHOQOL-BREF (0-100)
measure: Compare length of consultations between groups
time frame: every consultation for 12 months
description: minutes
measure: Clinician satisfaction concerning the therapeutic decisions taken between groups
time frame: 3 months
description: adapted QSH-45 doctor version 3 questions scored 1-5
measure: Clinician satisfaction concerning the therapeutic decisions taken between groups
time frame: 6 months
description: adapted QSH-45 doctor version 3 questions scored 1-5
measure: Clinician satisfaction concerning the therapeutic decisions taken between groups
time frame: 9 months
description: adapted QSH-45 doctor version 3 questions scored 1-5
measure: Clinician satisfaction concerning the therapeutic decisions taken between groups
time frame: 12 months
description: adapted QSH-45 doctor version 3 questions scored 1-5
measure: Clinician satisfaction concerning the decision-making process between groups
time frame: 3 months
description: Adapted clinical decision making involvement and satisfaction score doctor version 3: questions scored 1-5
measure: Clinician satisfaction concerning the decision-making process between groups
time frame: 6 months
description: Adapted clinical decision making involvement and satisfaction score doctor version 3: questions scored 1-5
measure: Clinician satisfaction concerning the decision-making process between groups
time frame: 9 months
description: Adapted clinical decision making involvement and satisfaction score doctor version 3: questions scored 1-5
measure: Clinician satisfaction concerning the decision-making process between groups
time frame: 12 months
description: Adapted clinical decision making involvement and satisfaction score doctor version 3: questions scored 1-5
measure: Clinician perceptions related to the uncertainty of the medical decisions taken between groups
time frame: 3 months
description: decisional conflict scale doctor version (0-100)
measure: Clinician perceptions related to the uncertainty of the medical decisions taken between groups
time frame: 6 months
description: decisional conflict scale doctor version (0-100)
measure: Clinician perceptions related to the uncertainty of the medical decisions taken between groups
time frame: 9 months
description: decisional conflict scale doctor version (0-100)
measure: Clinician perceptions related to the uncertainty of the medical decisions taken between groups
time frame: 12 months
description: decisional conflict scale doctor version (0-100)
arm group label: Shared Decision making for care
arm group label: Standard decision making for care
intervention type: Other
intervention name: Shared-decision making process
description: Completion of the Ottawa Personal Decision Guide to help guide care with the support of online and printed material describing the therapeutic options available
arm group label: Shared Decision making for care
intervention type: Other
intervention name: standard care
description: Care of patients according to standard practice of managing patients with bipolar disorder
arm group label: Standard decision making for care
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ludovic Samalin
role: Principal Investigator
affiliation: University Hospital, Clermont-Ferrand
last name: Ludovic Samalin, MD
phone: +33 (0)4 73 752 125
email: lsamalin@chu-clermontferrand.fr
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Bipolar Disorder