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AzTrials

Juvenile Idiopathic ArthritisSNAPS-JIANCT04791189

Survey on the Expectations of Adolescents With Juvenile Idiopathic Arthritis (JIA) Regarding Knowledge and Communication With Health Care Professionals in the Field of Sexual Health, and Their Parents' Views on the Subject. (SNAPS-JIA)

An observational study of Juvenile Idiopathic Arthritis, run by University Hospital, Clermont-Ferrand at 15 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Sexual health is a legitimate area to explore in the care of these patients, as it has such an impact on quality of life. However, addressing sexual health in a situation of chronic disease confronts the double societal taboo of disease and sexuality. Read more about this study

Who is it for?
Ages 18 to 45 years
Conditions the study is for
Juvenile Idiopathic Arthritis
What is being tested?
questionnaire
How many people
300 participants
Where
15 sitesFrance
Study dates
May 2021to Jun 2022
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 18 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: - Patients with juvenile rheumatoid arthritis aged from 18 to 45 years, and their parents

Who may be able to join

  • Patients :
  • Patients with juvenile rheumatoid arthritis aged from 18 to 45 years
  • - Major male or female patient [18 to 45 years of age] with juvenile idiopathic arthritis reported before the age of 16.
  • - Able to understand and complete the questionnaire online (speaking and reading French, with an internet connection for completion via RedCap°). ¬
  • - Able to give informed consent to participate
  • - Involving one's parents in the survey is not a prerequisite for inclusion.
Show all 12Show fewer
  • Parents :
  • Parents of patients with juvenile rheumatoid arthritis aged from 18 to 45 years
  • - Parents of adult patients with JIA
  • - Parents able to understand and complete the questionnaire online (speaking and reading French, having an internet connection for completion via Red Cap°).
  • - Able to give informed consent to participate
  • - The parents must have been in charge of the patient as a teenager.

Who cannot join

  • Persons opposing participation in the study. The study information letters will specify that participation is consent to participate in the study.
  • Protected persons

Trial locations and contacts

15 sites in 1 country.

Lise LACLAUTRE contact

+334 73 754 963

promo_interne_drci@chu-clermontferrand.fr

15 sites in 1 country

France15 sites

  • CHU Bordeaux Pellegrin

    Bordeau, 33000

    Thierry SHAEVERBEKE

    Thierry SHAEVERBEKE

  • AP-HP

    Boulogne-Billancourt, 92104

    Gilles Hayem

    Gilles Hayem

  • Hôpital de La Cavale Blanche

    Brest, 29200

    Valérie DEVAUCHELLE-PENSEC

    Valérie DEVAUCHELLE-PENSEC

  • CHU de Clermont-Ferrand

    Clermont-Ferrand, 63000

    Lise LACLAUTRE, +33473754963, promo_interne_drci@chu-clermontferrand.fr

    Carine SAVEL

  • CHUGA - Hôpital Sud

    Échirolles, 38434

    Philippe Gaudin

    Philippe Gaudin

  • CHR Metz-Thionville

    Metz, 57085

    Didier Poivret

    Didier Poivret

  • Association Nationale de Défense contre l'Arthrite Rhumatoïde

    Montpellier, 34080

    Sonia TROPE

    Sonia Trope

  • CHU de Montpellier

    Montpellier, 34090

    Jean David Cohen

    Jean David Cohen

  • Centre Hospitalier Universitaire de Nantes

    Nantes, 44093

    Pascale Guillot

    Pascale Guillot

  • CHU de Nice Hopital Pasteur

    Nice, 0600

    Laura Cabane

    Laura Cabane

  • Association KOURIR

    Paris, 75011

    Nadine PEZIERE

    Nadine PEZIERE

  • APHP La Pitié Salpétrière

    Paris, 75013

    Bruno Fautrel

    Bruno Fautrel

  • CHU de Strasbourg - Hôpital de Hautepierre

    Strasbourg, 67200

    Christelle Sordet

    Christelle Sordet

  • CHU Toulouse

    Toulouse, 31300

    Bénédicte Jamard

    Bénédicte Jamard

  • Association France Spondyloarthrite

    Tulle, 19000

    Delphine Lafarge

    Delphine Lafarge

Other trials in France

About this study

Official title: Survey on the Expectations of Adolescents With Juvenile Idiopathic Arthritis (JIA) Regarding Knowledge and Communication With Health Care Professionals in the Field of Sexual Health, and Their Parents' Views on the Subject.

Sexual health is a legitimate area to explore in the care of these patients, as it has such an impact on quality of life. However, addressing sexual health in a situation of chronic disease confronts the double societal taboo of disease and sexuality. Health professionals are uncomfortable because they are not trained to talk about the subject, especially in the presence of parents and with a teenager they have watched grow up.

In this context, a needs survey among juvenile idiopathic arthritis (JIA) patients and the point of view of their parents in the field of sexual health seems necessary.

Main objective: To determine the expectations of adolescents (aged 10-19 years) with juvenile idiopathic arthritis regarding knowledge and communication with health care professionals in the field of sexual health.

Read the detailed description

This study is non-interventional, multi-centre and does not change current practice.

It will begin with the construction in a multidisciplinary team of two "needs assessment" questionnaires, the first for adult patients who have suffered from JIA, the second for their parents.

They will be drawn up by three sexologists, two rheumatologists, a pediatrician, a nurse from UTEP, a biostatistician, a statistician specializing in questionnaire metrology, two patients with JIA, two parents of JIA patients, and the Director of the ANDAR patient association.

These "needs assessment" questionnaires, entirely anonymous, will be composed of closed, Likert scale or semi-open questions.

The questionnaires will be implemented under RedCap° for patient associations.

The material necessary for the study (invitation letter + "patients"/"parents"-information letters + paper questionnaires for both surveys + pre-stamped letters) will be in paper format for hospital centres. These centres will ensure the follow-up of the study.

The invitation to participate in the survey by mailing or newsletter or association website will be made by the heads of patient associations.

Being tested
questionnaire
Keywords
Juvenile idiopathic arthritis, Sexual health, Patient education, Needs assessment
Medical subject headings
Arthritis, Juvenile

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • questionnaireOther

    questionnaire to survey the needs of adolescents with juvenile idiopathic arthritis and the views of their parents in the area of sexual health.

Study groups in NCT04791189
Study groupRoleWhat they receive
Patients with juvenile rheumatoid arthritis aged from 18 to 45 years* Major male or female patient [18 to 45 years of age] with juvenile idiopathic arthritis reported before the age of 16. * - Able to understand and complete the questionnaire online (speaking and reading French, with an internet connection for completion via RedCap°). ¬ * - Able to give informed consent to participate * - Involving one's parents in the survey is not a prerequisite for inclusion.
Receives: Other: questionnaire
Parents of patients with juvenile rheumatoid arthritis aged from 18 to 45 yearsParents of adult patients with JIA * - Parents able to understand and complete the questionnaire online (speaking and reading French, having an internet connection for completion via Red Cap°). * - Able to give informed consent to participate * - The parents must have been in charge of the patient as a teenager.
Receives: Other: questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Responses of JIA patients to a questionnaire on their expectations during adolescence regarding knowledge and communication with health professionals in the field of sexual health ("patient needs assessment" questionnaire) .

    Responses of JIA patients to a questionnaire on their expectations during adolescence regarding knowledge and communication with health professionals in the field of sexual health ("patient needs assessment" questionnaire)

    Measured: Day 1

Secondary outcomes (2)

  1. Responses of JIA patients to a questionnaire on their expectations during adolescence regarding knowledge and communication with health professionals in the field of sexual health ("patient needs assessment" questionnaire)

    Responses of JIA patients to a questionnaire on their expectations during adolescence regarding knowledge and communication with health professionals in the field of sexual health ("patient needs assessment" questionnaire) .

    Measured: Day 1

  2. Responses of parents of JIA patients to a questionnaire on their child's assumed expectations during adolescence regarding knowledge and communication with health professionals in the field of sexual health ("parent needs assessment" questionnaire).

    Responses of parents of JIA patients to a questionnaire on their child's assumed expectations during adolescence regarding knowledge and communication with health professionals in the field of sexual health ("parent needs assessment" questionnaire).

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2021
  2. Study startMay 2021 (estimated)
  3. Primary completionFeb 2022 (estimated)
  4. Study completionJun 2022 (estimated)

Resources

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
Case only
Time perspective
Retrospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04791189
Sponsor's protocol ID
RNI 2020 SAVEL
Acronym
SNAPS-JIA
Status last verified
Mar 2021
First submitted
8 Mar 2021
Last updated
10 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Savel C, Chausset A, Berland P, Guiguet-Auclair C, Cabane L, Fautrel B, Gaudin P, Guillot P, Hayem G, Lafarge D, Merlin E, Peziere N, Sordet C, Trope S, Tournadre A, Malochet S, Cohen JD. Survey of adolescents' needs and parents' views on sexual health in juvenile idiopathic arthritis. Pediatr Rheumatol Online J. 2023 Sep 5;21(1):95. doi: 10.1186/s12969-023-00884-x.

    PubMed 37670340

Questions about this trial

What is this clinical trial studying?

An observational study of Juvenile Idiopathic Arthritis, run by University Hospital, Clermont-Ferrand at 15 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 12 inclusion and 2 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 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 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?

Responses of JIA patients to a questionnaire on their expectations during adolescence regarding knowledge and communication with health professionals in the field of sexual health ("patient needs assessment" questionnaire) . (time frame: Day 1). 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 NCT04791189, which also lists 1 linked publication.

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 10 Mar 2021.

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