<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/NCT03838939</url>
  </required_header>
  <id_info>
    <org_study_id>CHU-420</org_study_id>
    <secondary_id>2018-A00647-48</secondary_id>
    <nct_id>NCT03838939</nct_id>
  </id_info>
  <brief_title>Biotherapies and Therapeutic Education in Chronic Inflammatory Rheumatism</brief_title>
  <acronym>ERIBIO</acronym>
  <official_title>Impact of Association of Individual and Group Therapeutic Education Sessions on the Acquisition of Safety Skills by Patients With Chronic Inflammatory Rheumatism (CIR) Treated With Subcutaneous Biotherapy, Compared to Individual Therapeutic Education Sessions Alone</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>French Society of Rheumatology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Clermont-Ferrand</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 hypothesis is that group interaction associated with individual interviews intensify the&#xD;
      acquisition of safety skills compared to individual interviews alone in patients with CIR&#xD;
      treated by subcutaneous biotherapies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Selection and inclusion of patients will be done by principal investigator of Rheumatology&#xD;
      Department. After verification of inclusion and non-inclusion criteria by principal&#xD;
      investigator and signature of consent, patients will be randomized by 1: 1 randomization&#xD;
      (centralized randomization by statistician into 2 groups at M0) :&#xD;
&#xD;
        1. Experimental group (individual and group therapeutic education )&#xD;
&#xD;
             -  M0 (individual) Educational diagnosis and biotherapy education: &quot;subcutaneous&#xD;
                injection education&quot; and &quot;biotherapy management&quot;.&#xD;
&#xD;
             -  M3 (group with 3 to 10 patients) Intensification Biotherapy Education: Workshops :&#xD;
                &quot;Subcutaneous injection education&quot; and &quot;biotherapy management&quot;.&#xD;
&#xD;
             -  M6 (individual presential or by phone) Assessment of security skills and&#xD;
                questionnaires.&#xD;
&#xD;
             -  M12 (individual presential or by phone) Assessment of security skills and&#xD;
                questionnaires.&#xD;
&#xD;
        2. Control group (individual therapeutic education alone ) :&#xD;
&#xD;
             -  M0 (individual) Educational diagnosis and biotherapy education: &quot;subcutaneous&#xD;
                injection education&quot; and &quot;biotherapy management&quot;.&#xD;
&#xD;
             -  M3 (individual) Intensification Biotherapy Education: &quot;Subcutaneous injection&#xD;
                education&quot; and &quot;biotherapy management&quot;.&#xD;
&#xD;
             -  M6 (individual présential or by phone) Assessment of security skills and&#xD;
                questionnaires.&#xD;
&#xD;
             -  M12 (individual présential or by phone) Assessment of security skills and&#xD;
                questionnaires. Group session proposed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 21, 2019</start_date>
  <completion_date type="Actual">December 10, 2021</completion_date>
  <primary_completion_date type="Actual">December 10, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>no masking</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline Biosecure's score at 6 months after biological treatment initiation</measure>
    <time_frame>at 6 months</time_frame>
    <description>Biosecure questionnaire assesses safety skills regarding infections, vaccinations, and situations of daily life (travel, surgery, pregnancy,…). It's composed of 29 questions about knowledge and 7 scenarios. The response methods are: yes / no / I don't know, with 55 items (score from 0 to 100 points), developed by Therapeutic Education Section of French Society of Rheumatology.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Biosecure's score at 6 months after biological treatment initiation</measure>
    <time_frame>at 6 months</time_frame>
    <description>Biosecure questionnaire assesses safety skills regarding infections, vaccinations, and situations of daily life (travel, surgery, pregnancy,…). It's composed of 29 questions about knowledge and 7 scenarios. The response methods are: yes / no / I don't know, with 55 items (score from 0 to 100 points), developed by Therapeutic Education Section French Society of Rheumatology.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of hospitalizations for infection during the year, collected from patient (tracking book) and in medical file, at the follow-up at M12</measure>
    <time_frame>at 12 months</time_frame>
    <description>patient tracking book includes type of infection, stop biotherapy, consultation with attending physician, taking antibiotics, hospitalization and validation by treating physician</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of biotherapy stops and number of visits to physician for infection, collected from patient at M6 and M12 (tracking book)</measure>
    <time_frame>at 6 months and 12 months</time_frame>
    <description>patient tracking book includes type of infection, stop biotherapy, consultation with attending physician, taking antibiotics, hospitalization and validation by treating physician</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type of infections occurring, collected from patient at M6 and M12 (tracking book )</measure>
    <time_frame>at 6 months and 12 months</time_frame>
    <description>patient tracking book includes type of infection, stop biotherapy, consultation with attending physician, taking antibiotics, hospitalization and validation by treating physician</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Coping evaluated by analogical visual scale at M6 and M12</measure>
    <time_frame>at 6 months and 12 months</time_frame>
    <description>RAID questionnaire is calculated according to 7 numerical rating scales: pain, functional ability, fatigue, sleep, emotional well-being, physical well-being, and disease management. Each scale is evaluated by a number between 0 and 10. A final RAID score with high values characterize a disturbing state of the patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological well-being evaluated by Analogical visual scale at M6 and M12 by RAID questionnaire.</measure>
    <time_frame>at 6 months and 12 months</time_frame>
    <description>RAID questionnaire is calculated according to 7 numerical rating scales: pain, functional ability, fatigue, sleep, emotional well-being, physical well-being, and disease management. Each scale is evaluated by a number between 0 and 10. A final RAID score with high values characterize a disturbing state of the patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fear about treatment evaluated by FAIR questionnaire at M6 and M12.</measure>
    <time_frame>at 6 months and 12 months</time_frame>
    <description>FAIR questionnaire (Fear Assessment in Inflammatory Rheumatic diseases) evaluate the levels of fear (side effects of treatment, disease progress,…) and psychological distress in patients, it be included in clinical trial protocols to measure the impact of specific interventions on psychological distress</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction evaluated with Patient satisfaction questionnaire</measure>
    <time_frame>at 12 month</time_frame>
    <description>Patient satisfaction questionnaire items are: overall satisfaction of education sessions, quality of content in line with expectations, teaching methods and tools used, course flow, quality of the exchange</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <condition>Spondyloarthritis</condition>
  <arm_group>
    <arm_group_label>interventional group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>M3 (group with 3 to 10 patients) Intensification Biotherapy Education Workshops : &quot;Subcutaneous injection education&quot; and &quot;biotherapy management</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>M3 (individual) Intensification Biotherapy Education: &quot;Subcutaneous injection education&quot; and &quot;biotherapy management&quot;.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Therapeutic education</intervention_name>
    <description>Individual and group therapeutic education sessions will consist of :&#xD;
acquisition by patient of self-care skills such as performing subcutaneous injection,&#xD;
acquisition by patient of safety skills such as identifying symptoms that should lead to consult general practitioner, and stop treatment ...</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>interventional group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient age &gt; 18 years old with RA (ACR/EULAR criteria) or SA (ASAS criteria)&#xD;
             initiating a first subcutaneous biotherapy.&#xD;
&#xD;
          -  Patient able to complete a questionnaire&#xD;
&#xD;
          -  Patient giving informed consent.&#xD;
&#xD;
          -  Patient covered by social security&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  - Patient with disorder of higher mental function or psychiatric disorders.&#xD;
&#xD;
          -  Patient previously treated by intravenous biotherapy.&#xD;
&#xD;
          -  Protected populations: pregnant women, breastfeeding women, tutorship, trusteeship,&#xD;
             deprived of liberty, safeguard of justice.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Françoise FAYET</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Clermont-Ferrand</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chu Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Gossec L, Fautrel B, Flipon E, Lecoq d'Andre F, Marguerie L, Nataf H, Pallot Prades B, Piperno M, Poilverd RM, Rat AC, Sadji F, Sordet C, Thevenot C, Beauvais C. Safety of biologics: elaboration and validation of a questionnaire assessing patients' self-care safety skills: the BioSecure questionnaire. An initiative of the French Rheumatology Society Therapeutic Education section. Joint Bone Spine. 2013 Oct;80(5):471-6. doi: 10.1016/j.jbspin.2012.11.009. Epub 2013 Aug 20.</citation>
    <PMID>23972274</PMID>
  </reference>
  <reference>
    <citation>Gronning K, Rannestad T, Skomsvoll JF, Rygg LO, Steinsbekk A. Long-term effects of a nurse-led group and individual patient education programme for patients with chronic inflammatory polyarthritis - a randomised controlled trial. J Clin Nurs. 2014 Apr;23(7-8):1005-17. doi: 10.1111/jocn.12353. Epub 2013 Jul 22.</citation>
    <PMID>23875718</PMID>
  </reference>
  <reference>
    <citation>Homer D, Nightingale P, Jobanputra P. Providing patients with information about disease-modifying anti-rheumatic drugs: Individually or in groups? A pilot randomized controlled trial comparing adherence and satisfaction. Musculoskeletal Care. 2009 Jun;7(2):78-92. doi: 10.1002/msc.141.</citation>
    <PMID>18792423</PMID>
  </reference>
  <reference>
    <citation>Koev DJ, Tankova TI, Kozlovski PG. Effect of structured group education on glycemic control and hypoglycemia in insulin-treated patients. Diabetes Care. 2003 Jan;26(1):251. doi: 10.2337/diacare.26.1.251. No abstract available.</citation>
    <PMID>12502698</PMID>
  </reference>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>December 21, 2021</last_update_submitted>
  <last_update_submitted_qc>December 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>chronic inflammatory rheumatism</keyword>
  <keyword>biotherapies</keyword>
  <keyword>therapeutic education</keyword>
  <keyword>safety skills</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spondylitis</mesh_term>
    <mesh_term>Rheumatic Fever</mesh_term>
    <mesh_term>Spondylarthritis</mesh_term>
    <mesh_term>Rheumatic Diseases</mesh_term>
    <mesh_term>Collagen Diseases</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/NCT03838939
org study id: CHU-420
secondary id: 2018-A00647-48
nct id: NCT03838939
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The hypothesis is that group interaction associated with individual interviews intensify the
      acquisition of safety skills compared to individual interviews alone in patients with CIR
      treated by subcutaneous biotherapies.
Selection and inclusion of patients will be done by principal investigator of Rheumatology
      Department. After verification of inclusion and non-inclusion criteria by principal
      investigator and signature of consent, patients will be randomized by 1: 1 randomization
      (centralized randomization by statistician into 2 groups at M0) :

        1. Experimental group (individual and group therapeutic education )

             -  M0 (individual) Educational diagnosis and biotherapy education: "subcutaneous
                injection education" and "biotherapy management".

             -  M3 (group with 3 to 10 patients) Intensification Biotherapy Education: Workshops :
                "Subcutaneous injection education" and "biotherapy management".

             -  M6 (individual presential or by phone) Assessment of security skills and
                questionnaires.

             -  M12 (individual presential or by phone) Assessment of security skills and
                questionnaires.

        2. Control group (individual therapeutic education alone ) :

             -  M0 (individual) Educational diagnosis and biotherapy education: "subcutaneous
                injection education" and "biotherapy management".

             -  M3 (individual) Intensification Biotherapy Education: "Subcutaneous injection
                education" and "biotherapy management".

             -  M6 (individual présential or by phone) Assessment of security skills and
                questionnaires.

             -  M12 (individual présential or by phone) Assessment of security skills and
                questionnaires. Group session proposed.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: no masking
measure: Change from Baseline Biosecure's score at 6 months after biological treatment initiation
time frame: at 6 months
description: Biosecure questionnaire assesses safety skills regarding infections, vaccinations, and situations of daily life (travel, surgery, pregnancy,…). It's composed of 29 questions about knowledge and 7 scenarios. The response methods are: yes / no / I don't know, with 55 items (score from 0 to 100 points), developed by Therapeutic Education Section of French Society of Rheumatology.
measure: Change from Baseline Biosecure's score at 6 months after biological treatment initiation
time frame: at 6 months
description: Biosecure questionnaire assesses safety skills regarding infections, vaccinations, and situations of daily life (travel, surgery, pregnancy,…). It's composed of 29 questions about knowledge and 7 scenarios. The response methods are: yes / no / I don't know, with 55 items (score from 0 to 100 points), developed by Therapeutic Education Section French Society of Rheumatology.
measure: Number of hospitalizations for infection during the year, collected from patient (tracking book) and in medical file, at the follow-up at M12
time frame: at 12 months
description: patient tracking book includes type of infection, stop biotherapy, consultation with attending physician, taking antibiotics, hospitalization and validation by treating physician
measure: Number of biotherapy stops and number of visits to physician for infection, collected from patient at M6 and M12 (tracking book)
time frame: at 6 months and 12 months
description: patient tracking book includes type of infection, stop biotherapy, consultation with attending physician, taking antibiotics, hospitalization and validation by treating physician
measure: Type of infections occurring, collected from patient at M6 and M12 (tracking book )
time frame: at 6 months and 12 months
description: patient tracking book includes type of infection, stop biotherapy, consultation with attending physician, taking antibiotics, hospitalization and validation by treating physician
measure: Coping evaluated by analogical visual scale at M6 and M12
time frame: at 6 months and 12 months
description: RAID questionnaire is calculated according to 7 numerical rating scales: pain, functional ability, fatigue, sleep, emotional well-being, physical well-being, and disease management. Each scale is evaluated by a number between 0 and 10. A final RAID score with high values characterize a disturbing state of the patient
measure: Psychological well-being evaluated by Analogical visual scale at M6 and M12 by RAID questionnaire.
time frame: at 6 months and 12 months
description: RAID questionnaire is calculated according to 7 numerical rating scales: pain, functional ability, fatigue, sleep, emotional well-being, physical well-being, and disease management. Each scale is evaluated by a number between 0 and 10. A final RAID score with high values characterize a disturbing state of the patient.
measure: Fear about treatment evaluated by FAIR questionnaire at M6 and M12.
time frame: at 6 months and 12 months
description: FAIR questionnaire (Fear Assessment in Inflammatory Rheumatic diseases) evaluate the levels of fear (side effects of treatment, disease progress,…) and psychological distress in patients, it be included in clinical trial protocols to measure the impact of specific interventions on psychological distress
measure: Patient satisfaction evaluated with Patient satisfaction questionnaire
time frame: at 12 month
description: Patient satisfaction questionnaire items are: overall satisfaction of education sessions, quality of content in line with expectations, teaching methods and tools used, course flow, quality of the exchange
arm group label: interventional group
arm group type: Experimental
description: M3 (group with 3 to 10 patients) Intensification Biotherapy Education Workshops : "Subcutaneous injection education" and "biotherapy management
arm group label: Control group
arm group type: Placebo Comparator
description: M3 (individual) Intensification Biotherapy Education: "Subcutaneous injection education" and "biotherapy management".
intervention type: Other
intervention name: Therapeutic education
description: Individual and group therapeutic education sessions will consist of :
acquisition by patient of self-care skills such as performing subcutaneous injection,
acquisition by patient of safety skills such as identifying symptoms that should lead to consult general practitioner, and stop treatment ...
arm group label: Control group
arm group label: interventional group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Françoise FAYET
role: Principal Investigator
affiliation: University Hospital, Clermont-Ferrand
facility: 
country: France
citation: Gossec L, Fautrel B, Flipon E, Lecoq d'Andre F, Marguerie L, Nataf H, Pallot Prades B, Piperno M, Poilverd RM, Rat AC, Sadji F, Sordet C, Thevenot C, Beauvais C. Safety of biologics: elaboration and validation of a questionnaire assessing patients' self-care safety skills: the BioSecure questionnaire. An initiative of the French Rheumatology Society Therapeutic Education section. Joint Bone Spine. 2013 Oct;80(5):471-6. doi: 10.1016/j.jbspin.2012.11.009. Epub 2013 Aug 20.
PMID: 23972274
citation: Gronning K, Rannestad T, Skomsvoll JF, Rygg LO, Steinsbekk A. Long-term effects of a nurse-led group and individual patient education programme for patients with chronic inflammatory polyarthritis - a randomised controlled trial. J Clin Nurs. 2014 Apr;23(7-8):1005-17. doi: 10.1111/jocn.12353. Epub 2013 Jul 22.
PMID: 23875718
citation: Homer D, Nightingale P, Jobanputra P. Providing patients with information about disease-modifying anti-rheumatic drugs: Individually or in groups? A pilot randomized controlled trial comparing adherence and satisfaction. Musculoskeletal Care. 2009 Jun;7(2):78-92. doi: 10.1002/msc.141.
PMID: 18792423
citation: Koev DJ, Tankova TI, Kozlovski PG. Effect of structured group education on glycemic control and hypoglycemia in insulin-treated patients. Diabetes Care. 2003 Jan;26(1):251. doi: 10.2337/diacare.26.1.251. No abstract available.
PMID: 12502698
responsible party type: Sponsor
mesh term: Spondylitis
mesh term: Rheumatic Fever
mesh term: Spondylarthritis
mesh term: Rheumatic Diseases
mesh term: Collagen Diseases