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Completed

NCT Number: NCT03838939

Biotherapies and Therapeutic Education in Chronic Inflammatory Rheumatism

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Bone Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylitis Spondyloarthritis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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) :

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Therapeutic education

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • French Society of Rheumatology

Registry information

Official study 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

Acronym: ERIBIO

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Feb 12, 2019
Registry last updated
Dec 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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