Juvenile Idiopathic ArthritisAJILITTNCT05696340
Access to Pediatric Rheumatology Centers for JIA Patients: Factors Associated With Time to Access Pediatric Rheumatology Centers
An observational study of Juvenile Idiopathic Arthritis, run by University Hospital, Clermont-Ferrand at 4 sites in France.
Trial summary
JIA patients, their parents, and the health care professionals experience the complexity of the initial care pathway. The aim of the study is to explore the referral pathway to access pediatric rheumatology centers for JIA patients. Read more about this study
- Who is it for?
- Ages 11 years and olderHealthy volunteers can take part
- Conditions the study is for
- Juvenile Idiopathic Arthritis
- What is being tested?
- semi-structured interview
- How many people
- 45 participants
- Where
- 4 sitesFrance
- Study dates
- 18 Oct 2022to Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Children, adolescents, their parents, and the health care professionnals who have experienced the initial care pathway for JIA (between symptom onset and first visit with a pediatric rheumatologist).
Who may be able to join
- Children:
- age > 11 years
- JIA diagnosed between 4 and 24 months prior to the start of the study
- Parents:
- parent of a child with JIA diagnosed between 4 and 24 months prior to the start of the study
- Health care professional:
- Physician with experience in the initial management of children with JIA (between symptom onset and first visit with a pediatric rheumatologist).
Who cannot join
- For all participants:
- Refusal to participate in interviews
- Presenting a health condition incompatible with an interview
- Participants with inadequate French to take part in semi-structured interviews
Trial locations and contacts
4 sites in 1 country.
France4 sites, 4 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
Etienne MERLIN
Stephane ECHAUBARD
- Not yet recruiting
Hospices Civils de Lyon
Lyon
Alexandre BELOT
- Not yet recruiting
APHP
Paris
Caroline FREYCHET
- Recruiting
Hopital Nord Franche-Comté
Trévenans
Anne LOHSE
About this study
JIA patients, their parents, and the health care professionals experience the complexity of the initial care pathway. The aim of the study is to explore the referral pathway to access pediatric rheumatology centers for JIA patients. The exploration will aim to identify the barriers and facilitators of referral, based on the conceptual framework of the health literacy. The investigators will conduct a qualitative study using semi-structured interviews. The perspectives of parents/children/health care professionals will be crossed to enrich the data.
- Conditions
- Juvenile Idiopathic Arthritis
- Being tested
- semi-structured interview
- Keywords
- qualitative research, access to care, time to referral, health literacy
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semi-structured interviewOther
Subjects will be recruited in a purposive, non-randomized manner. Data will be collected to obtain a sufficient diversity of perspectives on the topic, while maintaining sufficient homogeneity for analysis.
The number of participants cannot be determined in advance; it will be determined after data saturation.
| Study group | Role | What they receive |
|---|---|---|
| JIA patients | Children diagnosed with JIA between 4 and 24 months before the start of the study, treated and followed in a pediatric rheumatology center (old enough to answer the questions) Receives: Other: semi-structured interview | |
| Parents of JIA patients | Parents of a child diagnosed with JIA between 4 and 24 months prior to the start of the study (treated and followed in a pediatric rheumatology center) Receives: Other: semi-structured interview | |
| Health care professionals | Physician with experience in the initial management of JIA patients (between symptom onset and first visit with a pediatric rheumatologist) Receives: Other: semi-structured interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Experience and views of barriers and solutions to the referral to pediatric rheumatology center for JIA patients
Through semi-structured interviews, the study will reconstruct the referral pathway to the pediatric rheumatology center for JIA patients.
- For patients and their parents, the interviews will focus on their experiences of the health care system, their feelings about interactions with health professional, their expectations and the elements that led to the parents' decision regarding their child's health.
- For health care professionals, the interviews will focus on their experience in managing children with JIA (from the symptom onset to the first visit with the pediatric rheumatologist), the difficulties they encountered, and the improvements to be made in training and communication.
Measured: About 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start18 Oct 2022
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Research on Healthcare Performance Lab U1290
- Responsible party
- Sponsor
- Investigators
- Aurélie CHAUSSET, Study director, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05696340
- Sponsor's protocol ID
- 2022 CHAUSSET AJILITT
- Acronym
- AJILITT
- Status last verified
- Dec 2022
- First submitted
- 22 Dec 2022
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chausset A, Pereira B, Echaubard S, Merlin E, Freychet C. Access to paediatric rheumatology care in juvenile idiopathic arthritis: what do we know? A systematic review. Rheumatology (Oxford). 2020 Dec 1;59(12):3633-3644. doi: 10.1093/rheumatology/keaa438.
PubMed 32940701Davies K, Cleary G, Foster H, Hutchinson E, Baildam E; British Society of Paediatric and Adolescent Rheumatology. BSPAR Standards of Care for children and young people with juvenile idiopathic arthritis. Rheumatology (Oxford). 2010 Jul;49(7):1406-8. doi: 10.1093/rheumatology/kep460. Epub 2010 Feb 19. No abstract available.
PubMed 20173199Scott C, Chan M, Slamang W, Okong'o L, Petty R, Laxer RM, Katsicas MM, Fredrick F, Chipeta J, Faller G, Pileggi G, Saad-Magalhaes C, Wouters C, Foster HE, Kubchandani R, Ruperto N, Russo R. Juvenile arthritis management in less resourced countries (JAMLess): consensus recommendations from the Cradle of Humankind. Clin Rheumatol. 2019 Feb;38(2):563-575. doi: 10.1007/s10067-018-4304-y. Epub 2018 Sep 28.
PubMed 30267356Chausset A, Freychet C, Lohse A, Belot A, Merlin E, Echaubard S, Schott AM, Lachal J. Diagnosis journey for children with juvenile idiopathic arthritis: a qualitative study. Arch Dis Child. 2024 Nov 19;109(12):1003-1009. doi: 10.1136/archdischild-2024-327426.
PubMed 39174297
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Access to Pediatric Rheumatology Centers for JIA Patients: Factors Associated With Time to Access Pediatric Rheumatology Centers
- ClinicalTrials.gov ID
- NCT05696340
- Acronym / sponsor ID
- AJILITT / 2022 CHAUSSET AJILITT
- Conditions
- Juvenile Idiopathic Arthritis
- Keywords
- qualitative research, access to care, time to referral, health literacy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Research on Healthcare Performance Lab U1290
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 25 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
JIA patients, their parents, and the health care professionals experience the complexity of the initial care pathway. The aim of the study is to explore the referral pathway to access pediatric rheumatology centers for JIA patients. The exploration will aim to identify the barriers and facilitators of referral, based on the conceptual framework of the health literacy. The investigators will conduct a qualitative study using semi-structured interviews. The perspectives of parents/children/health care professionals will be crossed to enrich the data.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| JIA patients | – | Other: semi-structured interviewChildren diagnosed with JIA between 4 and 24 months before the start of the study, treated and followed in a pediatric rheumatology center (old enough to answer the questions) |
| Parents of JIA patients | – | Other: semi-structured interviewParents of a child diagnosed with JIA between 4 and 24 months prior to the start of the study (treated and followed in a pediatric rheumatology center) |
| Health care professionals | – | Other: semi-structured interviewPhysician with experience in the initial management of JIA patients (between symptom onset and first visit with a pediatric rheumatologist) |
Who may qualify
- Ages
- 11 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children, adolescents, their parents, and the health care professionnals who have experienced the initial care pathway for JIA (between symptom onset and first visit with a pediatric rheumatologist).
Key inclusion criteria (7 listed)
- age > 11 years
- JIA diagnosed between 4 and 24 months prior to the start of the study
- parent of a child with JIA diagnosed between 4 and 24 months prior to the start of the study
- Physician with experience in the initial management of children with JIA (between symptom onset and first visit with a pediatric rheumatologist).
Key exclusion criteria (4 listed)
- Refusal to participate in interviews
- Presenting a health condition incompatible with an interview
- Participants with inadequate French to take part in semi-structured interviews
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| semi-structured interviewSubjects will be recruited in a purposive, non-randomized manner. Data will be collected to obtain a sufficient diversity of perspectives on the topic, while maintaining sufficient homogeneity for analysis. The number of participants cannot be determined in advance; it will be determined after data saturation. | Other | Health care professionals, JIA patients, Parents of JIA patients |
Primary outcome
Experience and views of barriers and solutions to the referral to pediatric rheumatology center for JIA patients
Time frame: About 1 hour
Through semi-structured interviews, the study will reconstruct the referral pathway to the pediatric rheumatology center for JIA patients. * For patients and their parents, the interviews will focus on their experiences of the health care system, their feelings about interactions with health professional, their expectations and the elements that led to the parents' decision regarding their child's health. * For health care professionals, the interviews will focus on their experience in managing children with JIA (from the symptom onset to the first visit with the pediatric rheumatologist), the difficulties they encountered, and the improvements to be made in training and communication.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Background: PubMed 32940701Chausset A, Pereira B, Echaubard S, Merlin E, Freychet C. Access to paediatric rheumatology care in juvenile idiopathic arthritis: what do we know? A systematic review. Rheumatology (Oxford). 2020 Dec 1;59(12):3633-3644. doi: 10.1093/rheumatology/keaa438.
- Background: PubMed 20173199Davies K, Cleary G, Foster H, Hutchinson E, Baildam E; British Society of Paediatric and Adolescent Rheumatology. BSPAR Standards of Care for children and young people with juvenile idiopathic arthritis. Rheumatology (Oxford). 2010 Jul;49(7):1406-8. doi: 10.1093/rheumatology/kep460. Epub 2010 Feb 19. No abstract available.
- Background: PubMed 30267356Scott C, Chan M, Slamang W, Okong'o L, Petty R, Laxer RM, Katsicas MM, Fredrick F, Chipeta J, Faller G, Pileggi G, Saad-Magalhaes C, Wouters C, Foster HE, Kubchandani R, Ruperto N, Russo R. Juvenile arthritis management in less resourced countries (JAMLess): consensus recommendations from the Cradle of Humankind. Clin Rheumatol. 2019 Feb;38(2):563-575. doi: 10.1007/s10067-018-4304-y. Epub 2018 Sep 28.
- Derived from this study: PubMed 39174297Chausset A, Freychet C, Lohse A, Belot A, Merlin E, Echaubard S, Schott AM, Lachal J. Diagnosis journey for children with juvenile idiopathic arthritis: a qualitative study. Arch Dis Child. 2024 Nov 19;109(12):1003-1009. doi: 10.1136/archdischild-2024-327426.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aurélie CHAUSSET study director
University Hospital, Clermont-Ferrand
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Juvenile Idiopathic Arthritis, run by University Hospital, Clermont-Ferrand at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise LACLAUTRE (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Experience and views of barriers and solutions to the referral to pediatric rheumatology center for JIA patients (time frame: About 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05696340, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2023.