Biotherapies and Therapeutic Education in Chronic Inflammatory Rheumatism

Rheumatoid Arthritis Clinical Trial

— ERIBIO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03838939
• Other study ID #: CHU-420
• Secondary ID: 2018-A00647-48
• Status: Completed
• Phase: N/A
• Start date: January 21, 2019
• Est. completion date: December 10, 2021

Study information

• Verified date: December 2021
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 10, 2021
• Est. primary completion date: December 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Collagen Diseases
• Rheumatic Diseases
• Rheumatic Fever
• Rheumatoid Arthritis
• Spondylarthritis
• Spondyloarthritis

Intervention

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 ...

Locations

Country	Name	City	State
France	Chu Clermont-Ferrand	Clermont-Ferrand

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	French Society of Rheumatology

Country where clinical trial is conducted

France, 

References & Publications (4)

Gossec L, Fautrel B, Flipon É, Lecoq d'André F, Marguerie L, Nataf H, Pallot Prades B, Piperno M, Poilverd RM, Rat AC, Sadji F, Sordet C, Thevenot C, Beauvais C. Safety of biologics: elaboration and validation of a questionnaire assessing patients' self-care safety skills: the BioSecure questionnaire. An initiative of the French Rheumatology Society Therapeutic Education section. Joint Bone Spine. 2013 Oct;80(5):471-6. doi: 10.1016/j.jbspin.2012.11.009. Epub 2013 Aug 20. — View Citation

Grønning K, Rannestad T, Skomsvoll JF, Rygg LØ, Steinsbekk A. Long-term effects of a nurse-led group and individual patient education programme for patients with chronic inflammatory polyarthritis - a randomised controlled trial. J Clin Nurs. 2014 Apr;23(7-8):1005-17. doi: 10.1111/jocn.12353. Epub 2013 Jul 22. — View Citation

Homer D, Nightingale P, Jobanputra P. Providing patients with information about disease-modifying anti-rheumatic drugs: Individually or in groups? A pilot randomized controlled trial comparing adherence and satisfaction. Musculoskeletal Care. 2009 Jun;7(2):78-92. doi: 10.1002/msc.141. — View Citation

Koev DJ, Tankova TI, Kozlovski PG. Effect of structured group education on glycemic control and hypoglycemia in insulin-treated patients. Diabetes Care. 2003 Jan;26(1):251. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Biosecure's score at 6 months after biological treatment initiation	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	Change from Baseline Biosecure's score at 6 months after biological treatment initiation	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
Secondary	Number of hospitalizations for infection during the year, collected from patient (tracking book) and in medical file, at the follow-up at M12	patient tracking book includes type of infection, stop biotherapy, consultation with attending physician, taking antibiotics, hospitalization and validation by treating physician	at 12 months
Secondary	Number of biotherapy stops and number of visits to physician for infection, collected from patient at M6 and M12 (tracking book)	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
Secondary	Type of infections occurring, collected from patient at M6 and M12 (tracking book )	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
Secondary	Coping evaluated by analogical visual scale at M6 and M12	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
Secondary	Psychological well-being evaluated by Analogical visual scale at M6 and M12 by RAID questionnaire.	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
Secondary	Fear about treatment evaluated by FAIR questionnaire at M6 and M12.	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
Secondary	Patient satisfaction evaluated with Patient satisfaction questionnaire	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