Juvenile Idiopathic ArthritisALLIANCENCT02824978
Therapeutic Alliance is it Associated With Better Compliance Amongst Children With Juvenile Idiopathic Arthritis ?
An observational study of Juvenile Idiopathic Arthritis, run by University Hospital, Brest at 17 sites in France.
Trial summary
to evalute if therapeutic alliance is related to adherence in JIA Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis
- How many people
- 120 participants
- Where
- 17 sitesFrance
- Study dates
- 7 Oct 2016to 1 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- Systemic form of JIA;
- Children aged under 8 years old or over 18 years;
- Child or parent does not understand French
- Refusal of participation
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
France17 sites
CHU Angers
Angers, 49033
Hôpital Nord Franche Comté
Belfort, 90015
CHRU Besançon
Besançon, 25030
CHU Bordeaux
Bordeaux, 33076
CHRU Brest
Brest, 29200
Hôpital Femme-Mère-Enfant - HCL
Bron, 69677
CHU Dijon
Dijon, 21079
CHU Martinique
Fort-de-France, 97261
Hôpital Bicêtre - APHP
Le Kremlin-Bicêtre, 94275
CHRU Lille
Lille, 59000
CH Mulhouse
Mulhouse, 68100
CHU Nîmes
Nîmes, 30029
Hôpital Necker-Enfants Malades - APHP
Paris, 75015
CHU Poitiers
Poitiers, 86021
CHU Rennes
Rennes, 35000
CHRU Strasbourg
Strasbourg, 67098
CHU Nancy
Vandœuvre-lès-Nancy, 54511
About this study
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.
- Conditions
- Juvenile Idiopathic Arthritis
- Medical subject headings
- Arthritis, Juvenile
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study start7 Oct 2016
- Primary completion1 Jan 2018
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valérie Devauchelle-Pensec, Professor, Principal investigator, University Hospital, Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02824978
- Sponsor's protocol ID
- ALLIANCE (RB 16.004 )
- Acronym
- ALLIANCE
- Status last verified
- Jul 2018
- First submitted
- 4 Jul 2016
- Last updated
- 12 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Alliance is it Associated With Better Compliance Amongst Children With Juvenile Idiopathic Arthritis ?
- ClinicalTrials.gov ID
- NCT02824978
- Acronym / sponsor ID
- ALLIANCE / ALLIANCE (RB 16.004 )
- Conditions
- Juvenile Idiopathic Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 7 Oct 2016 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 7 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Systemic form of JIA;
- Children aged under 8 years old or over 18 years;
- Child or parent does not understand French
- Refusal of participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Quality of Life (CHAQ Questionnaire )
Time frame: at inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valérie Devauchelle-Pensec, Professor principal investigator
University Hospital, Brest
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Juvenile Idiopathic Arthritis, run by University Hospital, Brest at 17 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between therapeutic alliance and compliance judged by the child ( CarQ Questionnaire) and parent ( PARQ Questionnaire). (time frame: at inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2018.