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

Completed

• Conditions: Juvenile Idiopathic Arthritis

• Registration Number: NCT02824978
• Lead Sponsor: University Hospital, Brest

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.

Study Timeline

• Study First Submitted: 2016-07-04
• Study First Submitted QC: 2016-07-04
• Study First Posted: 2016-07-07
• Study Start: 2016-10-07
• Primary Completion: 2018-01-01
• Study Completion: 2018-01-01
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-11
• Last Update Posted: 2018-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relationship between therapeutic alliance and compliance judged by the child ( CarQ Questionnaire) and parent ( PARQ Questionnaire).	at inclusion	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.

Secondary Outcome Measures

Name	Time	Method
Quality of Life (CHAQ Questionnaire )	at inclusion	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.

Trial Locations

Locations (17)

Hôpital Femme-Mère-Enfant - HCL; 🇫🇷 Bron, France

CHU Angers; 🇫🇷 Angers, France

Hôpital Nord Franche Comté; 🇫🇷 Belfort, France

CHRU Besançon; 🇫🇷 Besançon, France

CHU Bordeaux; 🇫🇷 Bordeaux, France

CHRU Brest; 🇫🇷 Brest, France

CH Mulhouse; 🇫🇷 Mulhouse, France

CHU Rennes; 🇫🇷 Rennes, France

CHU Dijon; 🇫🇷 Dijon, France

CHRU Lille; 🇫🇷 Lille, France

Hôpital Necker-Enfants Malades - APHP; 🇫🇷 Paris, France

CHU Martinique; 🇫🇷 Fort-de-France, France

Hôpital Bicêtre - APHP; 🇫🇷 Le Kremlin-Bicêtre, France

CHU Nîmes; 🇫🇷 Nîmes, France

CHU Poitiers; 🇫🇷 Poitiers, France

CHRU Strasbourg; 🇫🇷 Strasbourg, France

CHU Nancy; 🇫🇷 Vandœuvre-lès-Nancy, France