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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

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Spondyloarthritis Other: Therapeutic education Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Masking Description: no masking
Primary Purpose: Treatment
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
Estimated Study Start Date : February 28, 2019
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : June 30, 2022


Arm Intervention/treatment
Experimental: interventional group
M3 (group with 3 to 10 patients) Intensification Biotherapy Education Workshops : "Subcutaneous injection education" and "biotherapy management
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 ...

Placebo Comparator: Control group
M3 (individual) Intensification Biotherapy Education: "Subcutaneous injection education" and "biotherapy management".
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 ...




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  7. 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

  8. 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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03838939


Contacts
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Contact: Lise LACLAUTRE 04 73 75 49 63 drci@chu-clermontferrand.fr

Locations
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France
Chu Clermont-Ferrand Not yet recruiting
Clermont-Ferrand, France, 63003
Contact: Lise LACLAUTRE    04 73 75 49 63    drci@chu-clermontferrand.fr   
Principal Investigator: Françoise FAYET         
Sub-Investigator: Catherine BEAUVAIS         
Sub-Investigator: Béatrice PALLOT PRADES         
Sub-Investigator: Martine BERANGER         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
French Society of Rheumatology
Investigators
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Principal Investigator: Françoise FAYET University Hospital, Clermont-Ferrand

Publications:
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03838939     History of Changes
Other Study ID Numbers: CHU-420
2018-A00647-48 ( Other Identifier: 2018-A00647-48 )
First Posted: February 12, 2019    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Clermont-Ferrand:
chronic inflammatory rheumatism
biotherapies
therapeutic education
safety skills

Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Spondylarthritis
Rheumatic Diseases
Collagen Diseases
Rheumatic Fever
Arthritis
Joint Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Spondylitis
Spinal Diseases
Bone Diseases
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections