ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02824978
Recruitment Status : Completed
First Posted : July 7, 2016
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

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

Condition or disease
Juvenile Idiopathic Arthritis

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 Type : Observational
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02824978


Locations
France
CHU Angers
Angers, France, 49033
Hôpital Nord Franche Comté
Belfort, France, 90015
CHRU Besançon
Besançon, France, 25030
CHU Bordeaux
Bordeaux, France, 33076
CHRU Brest
Brest, France, 29200
Hôpital Femme-Mère-Enfant - HCL
Bron, France, 69677
CHU Dijon
Dijon, France, 21079
CHU Martinique
Fort-de-France, France, 97261
Hôpital Bicêtre - APHP
Le Kremlin-Bicêtre, France, 94275
CHRU Lille
Lille, France, 59000
CH Mulhouse
Mulhouse, France, 68100
CHU Nîmes
Nîmes, France, 30029
Hôpital Necker-Enfants Malades - APHP
Paris, France, 75015
CHU Poitiers
Poitiers, France, 86021
CHU Rennes
Rennes, France, 35000
CHRU Strasbourg
Strasbourg, France, 67098
CHU Nancy
Vandœuvre-lès-Nancy, France, 54511
Sponsors and Collaborators
University Hospital, Brest
Investigators
Principal Investigator: Valérie Devauchelle-Pensec, Professor University Hospital, Brest

Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT02824978     History of Changes
Other Study ID Numbers: ALLIANCE (RB 16.004 )
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
Arthritis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases