Representation and Medication Use in Juvenile Idiopathic Arthritis (RUMAJI)

Representation and Medication Use in Juvenile Idiopathic Arthritis - RUMAJI

According to the International League of Associations for Rheumatology classification, Juvenile Idiopathic Arthritis (JIA) comprises a heterogeneous group of arthritis of unknown cause and with onset before 16 years of age, characterized by joint inflammation lasting for 6 or more weeks. Few studies exist regarding the care experience of children affected by this rheumatic condition. On the other hand, methotrexate and biologics constitute the primary treatment for children with JIA. As with adults undergoing the same treatment, adherence is critical. Difficulties for children to take the drugs have been reported. Notwithstanding, if adherence promotion in pediatric chronic conditions has been the subject of recommendations with regard to care management, the investigators lack information to understand the grounds for adherence specifically in JIA. In order to understand and decipher the parent-child adherence mechanisms and practices, the RUMAJI study will be conducted. Indeed, improving the relational approach between children and their caregivers as well as unrestricted drug adherence involves researching and understanding how appropriation of the disease and treatment could be achieved.

Study Overview

• Status: Completed
• Conditions: Juvenile Idiopathic Arthritis
• Intervention / Treatment: Other: Interviews with Physicians; Other: Interviews with parents of children with juvenile idiopathic arthritis; Other: Interviews with children with juvenile idiopathic arthritis

• Study Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Uhmontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children with JIA and their parents

Description

Inclusion criteria:

• all JIA forms
• all treatment type (NSAIDs, MTX, bDMARDs)

Exclusion criteria:

- none

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Children	Other: Interviews with children with juvenile idiopathic arthritis; Interviews with children with juvenile idiopathic arthritis
Physicians; 3 paediatricians and 3 rheumatologists	Other: Interviews with Physicians; Interviews with Physicians
Parents	Other: Interviews with parents of children with juvenile idiopathic arthritis; Interviews with parents of children with juvenile idiopathic arthritis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interview with parents	Interview with parents to learn about role of parents in the management of juvenile idiopathic arthritis in their children	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interview with children	Interview with children to learn about role of children in the management of their juvenile idiopathic arthritis	1 day
Interview with physicians	Interview with physicians to learn about role of physicians in the management of juvenile idiopathic arthritis	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: Research department, unknowns, Strategic & innovation consulting, Paris (anthropologists); NORDIC pharma (funding)
• Investigators: Principal Investigator: Jean-David COHEN, MD, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2017
• Primary Completion (ACTUAL): October 1, 2017
• Study Completion (ACTUAL): December 1, 2017

Study Registration Dates

• First Submitted: March 18, 2019
• First Submitted That Met QC Criteria: March 25, 2019
• First Posted (ACTUAL): March 27, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 29, 2019
• Last Update Submitted That Met QC Criteria: April 25, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Adherence; Qualitative; Juvenile idiopathic arthritis; Interview; Role of parents, children and physician; mechanisms of adherence in juvenile idiopathic arthritis
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Juvenile
• Other Study ID Numbers: RECHMPL19_0171

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No