NCT03892135

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2017

Shorter than P25 for all trials

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

April 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 27, 2019

Completed
Last Updated

April 29, 2019

Status Verified

March 1, 2019

Enrollment Period

6 months

First QC Date

March 18, 2019

Last Update Submit

April 25, 2019

Conditions

Keywords

Role of parents, children and physicianQualitativeInterviewJuvenile idiopathic arthritisAdherencemechanisms of adherence in juvenile idiopathic arthritis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Interview with children

    1 day

  • Interview with physicians

    1 day

Study Arms (3)

Physicians

3 paediatricians and 3 rheumatologists

Other: Interviews with Physicians

Parents

Parents

Other: Interviews with parents of children with juvenile idiopathic arthritis

Children

Children

Other: Interviews with children with juvenile idiopathic arthritis

Interventions

Interviews with parents of children with juvenile idiopathic arthritis

Parents

Interviews with children with juvenile idiopathic arthritis

Children

Interviews with Physicians

Physicians

Eligibility Criteria

Age1 Year - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children with JIA and their parents

You may qualify if:

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

You may not qualify if:

  • \- none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

Interviews as TopicPhysicians

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthHealth PersonnelHealth Care Facilities Workforce and Services

Study Officials

  • Jean-David COHEN, MD

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2019

First Posted

March 27, 2019

Study Start

April 1, 2017

Primary Completion

October 1, 2017

Study Completion

December 1, 2017

Last Updated

April 29, 2019

Record last verified: 2019-03

Locations