NCT03838939

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 21, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 22, 2019

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 12, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2021

Completed
Last Updated

December 22, 2021

Status Verified

December 1, 2021

Enrollment Period

2.9 years

First QC Date

January 22, 2019

Last Update Submit

December 21, 2021

Conditions

Rheumatoid ArthritisSpondyloarthritis

Keywords

chronic inflammatory rheumatismbiotherapiestherapeutic educationsafety skills

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Change from Baseline Biosecure's score at 6 months after biological treatment initiation

    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

    at 12 months

  • 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

  • Type of infections occurring, collected from patient at M6 and M12 (tracking book )

    at 6 months and 12 months

  • Coping evaluated by analogical visual scale at M6 and M12

    at 6 months and 12 months

  • +3 more secondary outcomes

Study Arms (2)

interventional group

EXPERIMENTAL

M3 (group with 3 to 10 patients) Intensification Biotherapy Education Workshops : "Subcutaneous injection education" and "biotherapy management

Other: Therapeutic education

Control group

PLACEBO COMPARATOR

M3 (individual) Intensification Biotherapy Education: "Subcutaneous injection education" and "biotherapy management".

Other: Therapeutic education

Interventions

Therapeutic educationOTHER

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 ...

Control groupinterventional group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (5)

  • 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.

    PMID: 23972274BACKGROUND

  • 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.

    PMID: 23875718BACKGROUND

  • 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.

    PMID: 18792423BACKGROUND

  • 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.

    PMID: 12502698BACKGROUND

  • Fayet F, Beauvais C, Pereira B, Beranger M, Rodere M, Pallot-Prades B, Peyrard P, Pouplin S, Grandjean M, Chu Miow Lin D, Ardizzone M, Cherillat MS, Tournadre A, Fan A, Soubrier M. Comparison of group versus individual patient education for promoting safety skills of patients with autoimmune rheumatic diseases treated with biologics: a multicentre randomised controlled trial. Clin Rheumatol. 2025 Jan;44(1):487-494. doi: 10.1007/s10067-024-07218-6. Epub 2024 Nov 5.

    PMID: 39499437DERIVED

MeSH Terms

Conditions

Arthritis, RheumatoidSpondylarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesSpondylitisSpinal DiseasesBone Diseases

Study Officials

  • Françoise FAYET

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
no masking
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2019

First Posted

February 12, 2019

Study Start

January 21, 2019

Primary Completion

December 10, 2021

Study Completion

December 10, 2021

Last Updated

December 22, 2021

Record last verified: 2021-12

Locations

FR(1)