<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/NCT03754855</url>
  </required_header>
  <id_info>
    <org_study_id>CHUBX 2018/07</org_study_id>
    <nct_id>NCT03754855</nct_id>
  </id_info>
  <brief_title>Impact of Behavioral Factors on Treatment Adherence in a Sample of Rheumatoid Arthritis Patients</brief_title>
  <acronym>MAINTAIN</acronym>
  <official_title>Impact of Behavioral Factors on Treatment Adherence in a Sample of Rheumatoid Arthritis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Bordeaux</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Association Aquitaine de Recherche Clinique en Rhumatologie</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Bordeaux</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>
      Rheumatoid arthritis (RA) care has been revolutionized in the last decade with the advent of&#xD;
      biotherapies. Only 66% of treated patients are compliant. Nevertheless, studies analyzing the&#xD;
      medication adherence in RA are rare. The aim of this study is thus to evaluate RA treatment&#xD;
      adherence considering demographic data, vaccination coverage, feeding behavior and the use of&#xD;
      e-health tools.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rheumatoid arthritis (RA) care has been revolutionized in the last decade with the advent of&#xD;
      biotherapies. The success of this therapeutic strategy is based on several factors, including&#xD;
      the medication adherence. Whatever the method used, adherence evaluation is not sufficient,&#xD;
      around 66% of the treated patients. Nevertheless, studies analysing the predictive factors of&#xD;
      medication adherence in RA are rare.&#xD;
&#xD;
      RA patients are also educated about the infectious risk related to RA and treatments, and the&#xD;
      importance of vaccination. These recommendations are not always respected by the patients,&#xD;
      without knowing the exact factors leading to this decision. Furthermore, a lot of patients&#xD;
      take personal initiatives without the agreement and the help of their practitioner, like&#xD;
      diets or special feeding behaviors. Lastly, plenty of patients affected bv chronic diseases&#xD;
      claim and use electronic health tools without any real evidence of the efficacy of such&#xD;
      device.&#xD;
&#xD;
      The aim of this study is thus to evaluate RA treatment adherence considering demographic&#xD;
      data, vaccination coverage, feeding behavior and the use of e-health tools.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 28, 2018</start_date>
  <completion_date type="Actual">July 10, 2019</completion_date>
  <primary_completion_date type="Actual">July 10, 2019</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of patients who presented a good medication adherence according to the medication adherence questionnaire</measure>
    <time_frame>At baseline (day 0)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients vaccinated against influenza and pneumococcal bacteria</measure>
    <time_frame>At baseline (day 0)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of reasons of non-vaccination, globally and for each type of vaccination.</measure>
    <time_frame>At baseline (day 0)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of factors influencing rheumatologists to propose vaccination.</measure>
    <time_frame>At baseline (day 0)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of vaccinated patients who present a good medication adherence to RA specific therapies</measure>
    <time_frame>At baseline (day 0)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients using electronic health tools</measure>
    <time_frame>At baseline (day 0)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients using electronic health tools who present a good medication adherence to RA specific therapies</measure>
    <time_frame>At baseline (day 0)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with a special diet, globally and by type of diet</measure>
    <time_frame>At baseline (day 0)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients presenting functional bowel disorder</measure>
    <time_frame>At baseline (day 0)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with a special diet who present a good medication adherence to RA specific therapies</measure>
    <time_frame>At baseline (day 0)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with a good medication adherence, according to age</measure>
    <time_frame>At baseline (day 0)</time_frame>
    <description>Medication adherence will be evaluated with medication adherence questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with a good medication adherence, according to gender</measure>
    <time_frame>At baseline (day 0)</time_frame>
    <description>Medication adherence will be evaluated with medication adherence questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with a good medication adherence, according to socio-professional category</measure>
    <time_frame>At baseline (day 0)</time_frame>
    <description>Medication adherence will be evaluated with medication adherence questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with a good medication adherence, according to educational level</measure>
    <time_frame>At baseline (day 0)</time_frame>
    <description>Medication adherence will be evaluated with medication adherence questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with a good medication adherence, according to involvement in a patients association</measure>
    <time_frame>At baseline (day 0)</time_frame>
    <description>Medication adherence will be evaluated with medication adherence questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with a good medication adherence, according to alcohol and/or tobacco consumption</measure>
    <time_frame>At baseline (day 0)</time_frame>
    <description>Medication adherence will be evaluated with medication adherence questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with a good medication adherence, according to disease duration</measure>
    <time_frame>At baseline (day 0)</time_frame>
    <description>Medication adherence will be evaluated with medication adherence questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with a good medication adherence, according to rheumatoid factor and/or ACPA positivity</measure>
    <time_frame>At baseline (day 0)</time_frame>
    <description>Medication adherence will be evaluated with medication adherence questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with a good medication adherence, according to DAS28 score levels</measure>
    <time_frame>At baseline (day 0)</time_frame>
    <description>Medication adherence will be evaluated with medication adherence questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with a good medication adherence, according to actual RA treatments</measure>
    <time_frame>At baseline (day 0)</time_frame>
    <description>Medication adherence will be evaluated with medication adherence questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with a good medication adherence, according to the use of alternative therapies (acupuncture and/or sophrology).</measure>
    <time_frame>At baseline (day 0)</time_frame>
    <description>Medication adherence will be evaluated with medication adherence questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients for each personality trait category</measure>
    <time_frame>At baseline (day 0)</time_frame>
    <description>Personality trait categories will be evaluated by the French version of Big Five Inventory questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with a good medication adherence, according to each personality trait category</measure>
    <time_frame>At baseline (day 0)</time_frame>
    <description>Medication adherence will be evaluated with medication adherence questionnaires. Personality trait categories will be evaluated by the French version of Big Five Inventory questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with a vaccination coverage, according to each personality trait category.</measure>
    <time_frame>At baseline (day 0)</time_frame>
    <description>Personality trait categories will be evaluated by the French version of Big Five Inventory questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with a special diet, according to each personality trait category</measure>
    <time_frame>At baseline (day 0)</time_frame>
    <description>Personality trait categories will be evaluated by the French version of Big Five Inventory questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients using electronic health tools, according to each personality trait category</measure>
    <time_frame>At baseline (day 0)</time_frame>
    <description>Personality trait categories will be evaluated by the French version of Big Five Inventory questionnaire</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">590</enrollment>
  <condition>Arthritis, Rheumatoid</condition>
  <arm_group>
    <arm_group_label>Rheumatoid Arthritis patients</arm_group_label>
    <description>patients affected by RA according to ACR/EULAR 2010 criteria</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Questionnaire</intervention_name>
    <description>Questionnaire</description>
    <arm_group_label>Rheumatoid Arthritis patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient aged over 18 years old, affected by RA according to ACR/EULAR 2010 criteria&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient aged over 18 years old,&#xD;
&#xD;
          -  affected by RA according to ACR/EULAR 2010 criteria,&#xD;
&#xD;
          -  francophone,&#xD;
&#xD;
          -  and informed about the aims of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  guardianship patient,&#xD;
&#xD;
          -  patient who refuses to participate.&#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>Marie-Elise TRUCHETET, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Bordeaux</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU de Bordeaux - service de rhumatologie</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de Rhumatologie</name>
      <address>
        <city>Clermont-Ferrand</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de rhumatologie</name>
      <address>
        <city>Limoges</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de rhumatologie</name>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de Rhumatologie</name>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 22, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>June 19, 2020</last_update_submitted>
  <last_update_submitted_qc>June 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Rheumatoid arthritis</keyword>
  <keyword>medication adherence</keyword>
  <keyword>vaccination coverage</keyword>
  <keyword>electronic health tools</keyword>
  <keyword>diet</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</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/NCT03754855
org study id: CHUBX 2018/07
nct id: NCT03754855
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Rheumatoid arthritis (RA) care has been revolutionized in the last decade with the advent of
      biotherapies. Only 66% of treated patients are compliant. Nevertheless, studies analyzing the
      medication adherence in RA are rare. The aim of this study is thus to evaluate RA treatment
      adherence considering demographic data, vaccination coverage, feeding behavior and the use of
      e-health tools.
Rheumatoid arthritis (RA) care has been revolutionized in the last decade with the advent of
      biotherapies. The success of this therapeutic strategy is based on several factors, including
      the medication adherence. Whatever the method used, adherence evaluation is not sufficient,
      around 66% of the treated patients. Nevertheless, studies analysing the predictive factors of
      medication adherence in RA are rare.

      RA patients are also educated about the infectious risk related to RA and treatments, and the
      importance of vaccination. These recommendations are not always respected by the patients,
      without knowing the exact factors leading to this decision. Furthermore, a lot of patients
      take personal initiatives without the agreement and the help of their practitioner, like
      diets or special feeding behaviors. Lastly, plenty of patients affected bv chronic diseases
      claim and use electronic health tools without any real evidence of the efficacy of such
      device.

      The aim of this study is thus to evaluate RA treatment adherence considering demographic
      data, vaccination coverage, feeding behavior and the use of e-health tools.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Proportion of patients who presented a good medication adherence according to the medication adherence questionnaire
time frame: At baseline (day 0)
measure: Proportion of patients vaccinated against influenza and pneumococcal bacteria
time frame: At baseline (day 0)
measure: Proportion of reasons of non-vaccination, globally and for each type of vaccination.
time frame: At baseline (day 0)
measure: Proportion of factors influencing rheumatologists to propose vaccination.
time frame: At baseline (day 0)
measure: Proportion of vaccinated patients who present a good medication adherence to RA specific therapies
time frame: At baseline (day 0)
measure: Proportion of patients using electronic health tools
time frame: At baseline (day 0)
measure: Proportion of patients using electronic health tools who present a good medication adherence to RA specific therapies
time frame: At baseline (day 0)
measure: Proportion of patients with a special diet, globally and by type of diet
time frame: At baseline (day 0)
measure: Proportion of patients presenting functional bowel disorder
time frame: At baseline (day 0)
measure: Proportion of patients with a special diet who present a good medication adherence to RA specific therapies
time frame: At baseline (day 0)
measure: Number of patients with a good medication adherence, according to age
time frame: At baseline (day 0)
description: Medication adherence will be evaluated with medication adherence questionnaires
measure: Number of patients with a good medication adherence, according to gender
time frame: At baseline (day 0)
description: Medication adherence will be evaluated with medication adherence questionnaires
measure: Number of patients with a good medication adherence, according to socio-professional category
time frame: At baseline (day 0)
description: Medication adherence will be evaluated with medication adherence questionnaires
measure: Number of patients with a good medication adherence, according to educational level
time frame: At baseline (day 0)
description: Medication adherence will be evaluated with medication adherence questionnaires
measure: Number of patients with a good medication adherence, according to involvement in a patients association
time frame: At baseline (day 0)
description: Medication adherence will be evaluated with medication adherence questionnaires
measure: Number of patients with a good medication adherence, according to alcohol and/or tobacco consumption
time frame: At baseline (day 0)
description: Medication adherence will be evaluated with medication adherence questionnaires
measure: Number of patients with a good medication adherence, according to disease duration
time frame: At baseline (day 0)
description: Medication adherence will be evaluated with medication adherence questionnaires
measure: Number of patients with a good medication adherence, according to rheumatoid factor and/or ACPA positivity
time frame: At baseline (day 0)
description: Medication adherence will be evaluated with medication adherence questionnaires
measure: Number of patients with a good medication adherence, according to DAS28 score levels
time frame: At baseline (day 0)
description: Medication adherence will be evaluated with medication adherence questionnaires
measure: Number of patients with a good medication adherence, according to actual RA treatments
time frame: At baseline (day 0)
description: Medication adherence will be evaluated with medication adherence questionnaires
measure: Number of patients with a good medication adherence, according to the use of alternative therapies (acupuncture and/or sophrology).
time frame: At baseline (day 0)
description: Medication adherence will be evaluated with medication adherence questionnaires
measure: Number of patients for each personality trait category
time frame: At baseline (day 0)
description: Personality trait categories will be evaluated by the French version of Big Five Inventory questionnaire.
measure: Number of patients with a good medication adherence, according to each personality trait category
time frame: At baseline (day 0)
description: Medication adherence will be evaluated with medication adherence questionnaires. Personality trait categories will be evaluated by the French version of Big Five Inventory questionnaire.
measure: Number of patients with a vaccination coverage, according to each personality trait category.
time frame: At baseline (day 0)
description: Personality trait categories will be evaluated by the French version of Big Five Inventory questionnaire.
measure: Number of patients with a special diet, according to each personality trait category
time frame: At baseline (day 0)
description: Personality trait categories will be evaluated by the French version of Big Five Inventory questionnaire
measure: Number of patients using electronic health tools, according to each personality trait category
time frame: At baseline (day 0)
description: Personality trait categories will be evaluated by the French version of Big Five Inventory questionnaire
arm group label: Rheumatoid Arthritis patients
description: patients affected by RA according to ACR/EULAR 2010 criteria
intervention type: Behavioral
intervention name: Questionnaire
description: Questionnaire
arm group label: Rheumatoid Arthritis patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marie-Elise TRUCHETET, MD, PhD
role: Principal Investigator
affiliation: CHU Bordeaux
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
sharing ipd: No