Clinical trial NCT03838939: Biotherapies and Therapeutic Education in Chronic Inflammatory Rheumatism
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Spondyloarthritis
Keywords: chronic inflammatory rheumatism
biotherapies
therapeutic education
safety skills
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: French Society of Rheumatology
First posted: 2019-02-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Change from Baseline Biosecure's score at 6 months after biological treatment initiation
timeFrame: at 6 months
Secondary outcomes:
measure: Change from Baseline Biosecure's score at 6 months after biological treatment initiation
timeFrame: at 6 months
measure: Number of hospitalizations for infection during the year, collected from patient (tracking book) and in medical file, at the follow-up at M12
timeFrame: at 12 months
measure: Number of biotherapy stops and number of visits to physician for infection, collected from patient at M6 and M12 (tracking book)
timeFrame: at 6 months and 12 months
measure: Type of infections occurring, collected from patient at M6 and M12 (tracking book )
timeFrame: at 6 months and 12 months
measure: Coping evaluated by analogical visual scale at M6 and M12
timeFrame: at 6 months and 12 months
measure: Psychological well-being evaluated by Analogical visual scale at M6 and M12 by RAID questionnaire.
timeFrame: at 6 months and 12 months
measure: Fear about treatment evaluated by FAIR questionnaire at M6 and M12.
timeFrame: at 6 months and 12 months
measure: Patient satisfaction evaluated with Patient satisfaction questionnaire
timeFrame: at 12 month
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Chu Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Françoise FAYET
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gossec L, Fautrel B, Flipon E, Lecoq d'Andre 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.
citation: Gronning K, Rannestad T, Skomsvoll JF, Rygg LO, 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.
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.
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. doi: 10.2337/diacare.26.1.251. No abstract available.