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Biotherapies and Therapeutic Education in Chronic Inflammatory Rheumatism (ERIBIO)

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ClinicalTrials.gov Identifier: NCT03838939
Recruitment Status : Not yet recruiting
First Posted : February 12, 2019
Last Update Posted : February 12, 2019
Sponsor:
Collaborator:
French Society of Rheumatology
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Tracking Information
First Submitted Date  ICMJE January 22, 2019
First Posted Date  ICMJE February 12, 2019
Last Update Posted Date February 12, 2019
Estimated Study Start Date  ICMJE February 28, 2019
Estimated Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2019)
Change from Baseline Biosecure's score at 6 months after biological treatment initiation [ Time Frame: at 6 months ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2019)
  • Change from Baseline Biosecure's score at 6 months after biological treatment initiation [ Time Frame: at 6 months ]
    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.
  • 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 ]
    patient tracking book includes type of infection, stop biotherapy, consultation with attending physician, taking antibiotics, hospitalization and validation by treating physician
  • 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 ]
    patient tracking book includes type of infection, stop biotherapy, consultation with attending physician, taking antibiotics, hospitalization and validation by treating physician
  • Type of infections occurring, collected from patient at M6 and M12 (tracking book ) [ Time Frame: at 6 months and 12 months ]
    patient tracking book includes type of infection, stop biotherapy, consultation with attending physician, taking antibiotics, hospitalization and validation by treating physician
  • Coping evaluated by analogical visual scale at M6 and M12 [ Time Frame: at 6 months and 12 months ]
    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
  • Psychological well-being evaluated by Analogical visual scale at M6 and M12 by RAID questionnaire. [ Time Frame: at 6 months and 12 months ]
    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.
  • Fear about treatment evaluated by FAIR questionnaire at M6 and M12. [ Time Frame: at 6 months and 12 months ]
    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
  • Patient satisfaction evaluated with Patient satisfaction questionnaire [ Time Frame: at 12 month ]
    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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Biotherapies and Therapeutic Education in Chronic Inflammatory Rheumatism
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Masking Description:
no masking
Primary Purpose: Treatment
Condition  ICMJE
  • Rheumatoid Arthritis
  • Spondyloarthritis
Intervention  ICMJE Other: Therapeutic education

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 ...
Study Arms  ICMJE
  • Experimental: interventional group
    M3 (group with 3 to 10 patients) Intensification Biotherapy Education Workshops : "Subcutaneous injection education" and "biotherapy management
    Intervention: Other: Therapeutic education
  • Placebo Comparator: Control group
    M3 (individual) Intensification Biotherapy Education: "Subcutaneous injection education" and "biotherapy management".
    Intervention: Other: Therapeutic education
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: February 11, 2019)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2022
Estimated Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient age > 18 years old with RA (ACR/EULAR criteria) or SA (ASAS criteria) initiating a first subcutaneous biotherapy.
  • Patient able to complete a questionnaire
  • Patient giving informed consent.
  • Patient covered by social security

Exclusion Criteria:

  • - Patient with disorder of higher mental function or psychiatric disorders.
  • Patient previously treated by intravenous biotherapy.
  • Protected populations: pregnant women, breastfeeding women, tutorship, trusteeship, deprived of liberty, safeguard of justice.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lise LACLAUTRE 04 73 75 49 63 drci@chu-clermontferrand.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03838939
Other Study ID Numbers  ICMJE CHU-420
2018-A00647-48 ( Other Identifier: 2018-A00647-48 )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Clermont-Ferrand
Study Sponsor  ICMJE University Hospital, Clermont-Ferrand
Collaborators  ICMJE French Society of Rheumatology
Investigators  ICMJE
Principal Investigator: Françoise FAYET University Hospital, Clermont-Ferrand
PRS Account University Hospital, Clermont-Ferrand
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP