Biotherapies and Therapeutic Education in Chronic Inflammatory Rheumatism (ERIBIO)

December 21, 2021 updated by: University Hospital, Clermont-Ferrand

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • CHU Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 ...

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at 6 months
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
at 12 months
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
at 6 months and 12 months
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
at 6 months and 12 months
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
at 6 months and 12 months
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.
at 6 months and 12 months
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
at 6 months and 12 months
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
at 12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

French Society of Rheumatology

Investigators

  • Principal Investigator: Françoise FAYET, University Hospital, Clermont-Ferrand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2019

Primary Completion (Actual)

December 10, 2021

Study Completion (Actual)

December 10, 2021

Study Registration Dates

First Submitted

January 22, 2019

First Submitted That Met QC Criteria

February 11, 2019

First Posted (Actual)

February 12, 2019

Study Record Updates

Last Update Posted (Actual)

December 22, 2021

Last Update Submitted That Met QC Criteria

December 21, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-420
  • 2018-A00647-48 (Other Identifier: 2018-A00647-48)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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