Therapeutic Alliance is it Associated With Better Compliance Amongst Children With Juvenile Idiopathic Arthritis ?

Juvenile Idiopathic Arthritis Clinical Trial

— ALLIANCE  

Official title:

Therapeutic Alliance is it Associated With Better Compliance Amongst Children With Juvenile Idiopathic Arthritis ?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02824978
• Other study ID #: ALLIANCE (RB 16.004 )
• Status: Completed
• Start date: October 7, 2016
• Est. completion date: January 1, 2018

Study information

• Verified date: July 2018
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

to evalute if therapeutic alliance is related to adherence in JIA

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 1, 2018
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Juvenile Idiopathic Arthritis

Locations

Country	Name	City	State
France	CHU Angers	Angers
France	Hôpital Nord Franche Comté	Belfort
France	CHRU Besançon	Besançon
France	CHU Bordeaux	Bordeaux
France	CHRU Brest	Brest
France	Hôpital Femme-Mère-Enfant - HCL	Bron
France	CHU Dijon	Dijon
France	CHU Martinique	Fort-de-France
France	Hôpital Bicêtre - APHP	Le Kremlin-Bicêtre
France	CHRU Lille	Lille
France	CH Mulhouse	Mulhouse
France	CHU Nîmes	Nîmes
France	Hôpital Necker-Enfants Malades - APHP	Paris
France	CHU Poitiers	Poitiers
France	CHU Rennes	Rennes
France	CHRU Strasbourg	Strasbourg
France	CHU Nancy	Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relationship between therapeutic alliance and compliance judged by the child ( CarQ Questionnaire) and parent ( PARQ Questionnaire).	Several questionnaires (6-8) measure the alliance in adults and have shown the link between early alliance and therapeutic efficacy and especially the need to measure not made by the therapist but by the treatment. Then the scores were developed in children where the alliance is special since the role of the adult, the parent is part of the monitoring and assistance to the acceptance of the disease and guarantee the continuity of care . Among them, the HQA I was designed to examine the child-parent-caregiver triad. The HQA-CP score (Helping questionnaires Alliance for Child and Parents) is derived from this score. HQA-CP was validated in French by Kermarrec et al.	at inclusion
Secondary	Quality of Life (CHAQ Questionnaire )	The quality of life related to health is important to consider in children in JIA. It can be modified by the treatment, and many other non-medical factors, some limit adherence. Research has shown that better adherence to treatment was associated with a better quality of life. The quality of life is typically measured by the validated CHAQ in French since 2001. It includes 30 items divided into eight areas rated from 0 to 3. It has been validated for different age groups.	at inclusion