Biotherapies and Therapeutic Education in Chronic Inflammatory Rheumatism

Not Applicable

Completed

• Conditions: Rheumatoid Arthritis; Spondyloarthritis
• Interventions: Other: Therapeutic education

• Registration Number: NCT03838939
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2019-01-21
• Study First Submitted: 2019-01-22
• Study First Submitted QC: 2019-02-11
• Study First Posted: 2019-02-12
• Status Verified: 2021-12
• Primary Completion: 2021-12-10
• Study Completion: 2021-12-10
• Last Update Submitted: 2021-12-21
• Last Update Posted: 2021-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
interventional group	Therapeutic education	M3 (group with 3 to 10 patients) Intensification Biotherapy Education Workshops : "Subcutaneous injection education" and "biotherapy management
Control group	Therapeutic education	M3 (individual) Intensification Biotherapy Education: "Subcutaneous injection education" and "biotherapy management".

Primary Outcome Measures

Name	Time	Method
Change from Baseline Biosecure's score at 6 months after biological treatment initiation	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

Name	Time	Method
Change from Baseline Biosecure's score at 6 months after biological treatment initiation	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	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)	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 )	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	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.	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.	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	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

Trial Locations

Locations (1)

Chu Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France