NCT02824978

Brief Summary

to evalute if therapeutic alliance is related to adherence in JIA

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 4, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 7, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

October 7, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

July 12, 2018

Status Verified

July 1, 2018

Enrollment Period

1.2 years

First QC Date

July 4, 2016

Last Update Submit

July 11, 2018

Conditions

Outcome Measures

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.

    at inclusion

Secondary Outcomes (1)

  • Quality of Life (CHAQ Questionnaire )

    at inclusion

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • Systemic form of JIA;
  • Children aged under 8 years old or over 18 years;
  • Child or parent does not understand French
  • Refusal of participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

CHU Angers

Angers, 49033, France

Location

Hôpital Nord Franche Comté

Belfort, 90015, France

Location

CHRU Besançon

Besançon, 25030, France

Location

CHU Bordeaux

Bordeaux, 33076, France

Location

CHRU Brest

Brest, 29200, France

Location

Hôpital Femme-Mère-Enfant - HCL

Bron, 69677, France

Location

CHU Dijon

Dijon, 21079, France

Location

CHU Martinique

Fort-de-France, 97261, France

Location

Hôpital Bicêtre - APHP

Le Kremlin-Bicêtre, 94275, France

Location

CHRU Lille

Lille, 59000, France

Location

CH Mulhouse

Mulhouse, 68100, France

Location

CHU Nîmes

Nîmes, 30029, France

Location

Hôpital Necker-Enfants Malades - APHP

Paris, 75015, France

Location

CHU Poitiers

Poitiers, 86021, France

Location

CHU Rennes

Rennes, 35000, France

Location

CHRU Strasbourg

Strasbourg, 67098, France

Location

CHU Nancy

Vandœuvre-lès-Nancy, 54511, France

Location

MeSH Terms

Conditions

Arthritis, Juvenile

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Valérie Devauchelle-Pensec, Professor

    University Hospital, Brest

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2016

First Posted

July 7, 2016

Study Start

October 7, 2016

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

July 12, 2018

Record last verified: 2018-07

Locations