Therapeutic Alliance is it Associated With Better Compliance Amongst Children With Juvenile Idiopathic Arthritis ? (ALLIANCE)
|ClinicalTrials.gov Identifier: NCT02824978|
Recruitment Status : Completed
First Posted : July 7, 2016
Last Update Posted : July 12, 2018
|Condition or disease|
|Juvenile Idiopathic Arthritis|
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 Type :||Observational|
|Actual Enrollment :||120 participants|
|Official Title:||Therapeutic Alliance is it Associated With Better Compliance Amongst Children With Juvenile Idiopathic Arthritis ?|
|Actual Study Start Date :||October 7, 2016|
|Actual Primary Completion Date :||January 1, 2018|
|Actual Study Completion Date :||January 1, 2018|
- Relationship between therapeutic alliance and compliance judged by the child ( CarQ Questionnaire) and parent ( PARQ Questionnaire). [ Time Frame: 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.
- Quality of Life (CHAQ Questionnaire ) [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02824978
|Angers, France, 49033|
|Hôpital Nord Franche Comté|
|Belfort, France, 90015|
|Besançon, France, 25030|
|Bordeaux, France, 33076|
|Brest, France, 29200|
|Hôpital Femme-Mère-Enfant - HCL|
|Bron, France, 69677|
|Dijon, France, 21079|
|Fort-de-France, France, 97261|
|Hôpital Bicêtre - APHP|
|Le Kremlin-Bicêtre, France, 94275|
|Lille, France, 59000|
|Mulhouse, France, 68100|
|Nîmes, France, 30029|
|Hôpital Necker-Enfants Malades - APHP|
|Paris, France, 75015|
|Poitiers, France, 86021|
|Rennes, France, 35000|
|Strasbourg, France, 67098|
|Vandœuvre-lès-Nancy, France, 54511|
|Principal Investigator:||Valérie Devauchelle-Pensec, Professor||University Hospital, Brest|