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CompletedNCT02824978ALLIANCEUpdated Jul 12, 2018

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

An observational study in Juvenile Idiopathic Arthritis, sponsored by University Hospital, Brest. Completed at 17 sites in France. Open to participants aged 8 Years to 18 Years. Per ClinicalTrials.gov, last updated 2018-07-12.

Sponsored by University Hospital, Brest · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
8 Years to 18 Years
Sex
All
01

Study summary

to evalute if therapeutic alliance is related to adherence in JIA

Read the 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.

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Conditions studied

  • Juvenile Idiopathic Arthritis
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In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 318 are open to participants now.

This study's enrollment of 120 is below the median of 155 across 1,057 observational studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

University Hospital, Brest is the lead sponsor of 594 studies on the registry; 135 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
8 Years to 18 Years
Sexes eligible
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.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: at inclusion

Secondary outcomes

  1. 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.

    Time frame: at inclusion

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Study locations

17 sites
  • CHU Angers
    Angers, 49033, France
  • Hôpital Nord Franche Comté
    Belfort, 90015, France
  • CHRU Besançon
    Besançon, 25030, France
  • CHU Bordeaux
    Bordeaux, 33076, France
  • CHRU Brest
    Brest, 29200, France
  • Hôpital Femme-Mère-Enfant - HCL
    Bron, 69677, France
  • CHU Dijon
    Dijon, 21079, France
  • CHU Martinique
    Fort-de-France, 97261, France
  • Hôpital Bicêtre - APHP
    Le Kremlin-Bicêtre, 94275, France
  • CHRU Lille
    Lille, 59000, France
  • CH Mulhouse
    Mulhouse, 68100, France
  • CHU Nîmes
    Nîmes, 30029, France
  • Hôpital Necker-Enfants Malades - APHP
    Paris, 75015, France
  • CHU Poitiers
    Poitiers, 86021, France
  • CHU Rennes
    Rennes, 35000, France
  • CHRU Strasbourg
    Strasbourg, 67098, France
  • CHU Nancy
    Vandœuvre-lès-Nancy, 54511, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 12, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02824978
Lead sponsor
University Hospital, Brest
Responsible party
Sponsor
First posted
Jul 7, 2016
Start date
Oct 7, 2016
Primary completion
Jan 1, 2018
Completion
Jan 1, 2018
Last update
Jul 12, 2018

Study contacts

Valérie Devauchelle-Pensec, Professor
principal investigator · University Hospital, Brest

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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