Clinical trial NCT02824978: Therapeutic Alliance is it Associated With Better Compliance Amongst Children With Juvenile Idiopathic Arthritis ?
Official title: Therapeutic Alliance is it Associated With Better Compliance Amongst Children With Juvenile Idiopathic Arthritis ?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Juvenile Idiopathic Arthritis
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2016-07-07
Enrollment: 120
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children with Juvenile idiopathic arthritis (JIA) and aged from 8 to 18 years, that have been akready seen more than 2 times in consultation by the same practitioner.

Treatment is based on the non-steroidal anti-inflammatory drugs, corticosteroids or immunosuppressant therapy and due to chronic nature of JIA, it requires a strong ability of the child to follow his treatment. The role of parents going to be important and the relationship built with the caregiver is essential. As much as in adults, and can be more complex way the question of adherence / therapeutic adherence.

Brief summary: to evalute if therapeutic alliance is related to adherence in JIA

Detailed description: The therapeutic alliance is the agreement that is being built between doctor and patient during the construction process of care. So active collaboration based on a shared assessment of issues and agreement on possible solutions. Initially described in psychiatry, this analytical concept has been extended to several chronic diseases in particular requiring more often a strong link between doctor and patient. His measure is important since it has been demonstrated by several previous studies that the therapeutic alliance is predictive of the therapeutic effects of treatment. This alliance, however, was little studied in juvenile idiopathic arthritis, its connection with the observance or the quality of life has never been evaluated.

The chronic nature of juvenile idiopathic arthritis (JIA) requires a strong ability of the child to follow his treatment, where the role of parents going to be important and where the relationship built with the caregiver is also essential.

Adherence is a complex concept for which there is no ideal measure. Direct evaluation criteria such as bioassays prove still incomplete and difficult to implement in observational studies. Indirect measures have been developed through self-administered questionnaires and literature showed their relatively good correlation with actual catches. The innovative hypothesis of this research is that a better therapeutic alliance is associated with better adherence child in JIA.

Eligibility criteria: Inclusion Criteria:

* Patients with JIA (see classification above)
* Aged at least 8 to 18 years.
* Having already seen more than 2 times in consultation with the referring physician will even include the child in the study so that the alliance could build process
* Children can read, understand and complete questionnaires
* No opposition made

Exclusion Criteria:

* Systemic form of JIA;
* Children aged under 8 years old or over 18 years;
* Child or parent does not understand French
* Refusal of participation

Primary outcomes:
measure: Relationship between therapeutic alliance and compliance judged by the child ( CarQ Questionnaire) and parent ( PARQ Questionnaire).
timeFrame: at inclusion
Secondary outcomes:
measure: Quality of Life (CHAQ Questionnaire )
timeFrame: at inclusion
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Belfort
country: France
facility: Hôpital Nord Franche Comté
city: Besançon
country: France
facility: CHRU Besançon
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Brest
country: France
facility: CHRU Brest
city: Bron
country: France
facility: Hôpital Femme-Mère-Enfant - HCL
city: Dijon
country: France
facility: CHU Dijon
city: Fort-de-France
country: France
facility: CHU Martinique
city: Le Kremlin-Bicêtre
country: France
facility: Hôpital Bicêtre - APHP
city: Lille
country: France
facility: CHRU Lille
city: Mulhouse
country: France
facility: CH Mulhouse
city: Nîmes
country: France
facility: CHU Nîmes
city: Paris
country: France
facility: Hôpital Necker-Enfants Malades - APHP
city: Poitiers
country: France
facility: CHU Poitiers
city: Rennes
country: France
facility: CHU Rennes
city: Strasbourg
country: France
facility: CHRU Strasbourg
city: Vandœuvre-lès-Nancy
country: France
facility: CHU Nancy
Study officials:
affiliation: University Hospital, Brest
name: Valérie Devauchelle-Pensec, Professor
role: PRINCIPAL_INVESTIGATOR
References: